Prostate CancerPhase 1NCT03253744
Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy
A Phase 1 study testing 18F-DCFPyL, Tumor Irradiation and Prostate + tumor irradiation in people with Prostate Cancer and Prostatic Neoplasm, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Prostate cancer is the second leading cause of cancer death in United States (U.S.) men. Radiation is an effective treatment for most patients with localized prostate cancer, but sometimes the tumor returns. Researchers want to see if a highly focused type of radiation can help. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostatic Neoplasm
- What is being tested?
- 18F-DCFPyL, Tumor Irradiation and Prostate + tumor irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2018to 30 Jan 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed locally recurrent adenocarcinoma of the prostate after prior radiation (external beam radiation therapy (EBRT) or brachytherapy).
- Prostate-specific antigen (PSA) failure after definitive radiation as defined by the Phoenix criteria (PSA elevation at least 2 nanograms (ng) per deciliter (dL) above post-radiotherapy nadir)
- Age greater than or equal to 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).
- Ability of subject to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients who are receiving any other investigational agents.
- PSA greater than or equal to 20 ng/dL if no prior 2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid (18F-DCFPyL) scan obtained (If PSA > 20 and 18F-DCFPyL obtained within 3 months prior to enrollment shows no evidence of metastatic disease, subjects may be included in the study)
- Biochemical recurrence within one year of completion of radiotherapy
- Need for chronic anticoagulation therapy (chronic low dose aspirin is not an exclusion)
- Pre-existing and ongoing radiation-related grade 3 bowel or bladder toxicity
- Inflammatory bowel disease
Show all 17Show fewer
- Active Lupus or Active scleroderma
- Patients with distant metastatic disease (prostate adjacent adenopathy is not an exclusion)
- Prior prostatectomy
- Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
- Subjects with severe claustrophobia that is unresponsive to oral anxiolytics
- Other medical conditions deemed by the Principal Investigator (or associates) to make the subject unsafe or ineligible for protocol procedures
- Subjects weighing > 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry
- Serum creatinine > 2 times the upper limit of normal
- Total bilirubin > 2 times the upper limit of normal OR in patients with Gilbert's syndrome, a total bilirubin > 3.0.
- Liver transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (AST) greater than 3 times the upper limit of normal
- Patients with positive Human Immunodeficiency Virus (HIV) status and currently requiring treatment with agents known to sensitize to irradiation, such as protease inhibitors.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Phase I Trial of Image Guided Focally Dose Escalated Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy
Background:
Prostate cancer is the second leading cause of cancer death in United States (U.S.) men. Radiation is an effective treatment for most patients with localized prostate cancer, but sometimes the tumor returns. Researchers want to see if a highly focused type of radiation can help. It is given in only 5 treatments. It is called stereotactic body radiation therapy (SBRT).
Read more
Objective:
To study the maximum tolerated dose and side effects of stereotactic body radiation therapy in people with a local recurrence of prostate cancer after radiation.
Eligibility:
Men at least 18 years old who have recurrent prostate cancer after radiation therapy and no evidence of distant metastatic disease.
Design:
Participants will be screened with blood tests, physical exam, and medical history. They may also have:
Magnetic resonance imaging (MRI) scan of the prostate.
Positron emission tomography (PET)/computed tomography (CT) scan. Participants will get an injection of 2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid (18F-DCFPyL) for the PET scan. They will lie very still on their back on the scanner table.
Small samples of prostate tumor tissue will be taken by a needle through the skin or rectum to see if the cancer is in the prostate. Small metal seeds will be placed into the prostate at the same time to help guide the radiation.
About 2 weeks later, participants will have a radiation treatment planning CT scan.
Participants will answer questions about their urine function, bowel function, erectile function, and mood.
Participants will receive SBRT. They will have 5 radiation treatments over 2 weeks.
Participants will have follow-up visits. They will have a physical exam, blood tests, and questionnaires.
Six months after ending SBRT, the 18F-DCFPyL PET/CT will be repeated.
Participants will continue to have routine visits until two years after treatment is completed....
Read the detailed description
Background:
- Prostate cancer that recurs after prior radiation treatment can be challenging to cure due to the side effects of available treatments such as surgery and cryoablation.
- Re-irradiation with brachytherapy or stereotactic approaches has shown excellent rates of prostate cancer disease control with tolerable side effects.
- Using image guidance to allow highly conformal focal re-irradiation may potentially increase the efficacy of re-irradiation.
Objectives:
-Define the maximum tolerated dose (MTD) of image guided, focally dose escalated prostate radiation with stereotactic body radiation therapy (SBRT) in patients with a local recurrence of prostate cancer after prior radiotherapy.
Eligibility:
- Histological confirmation of recurrent prostate cancer after prior irradiation (external beam or brachytherapy)
- No evidence of distant metastases of prostate cancer
- No prior prostatectomy
- Subject is greater than or equal to18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).
Design:
- This is a Phase I trial of focal dose escalation with SBRT using image and pathologic guidance.
- Areas in the prostate shown to have tumor on biopsy or with advanced imaging studies will be treated with highly conformal SBRT over a period of two to three weeks. Treatment will be guided and gated by fiducials implanted in the prostate.
- Patients will be treated to escalating doses based on tolerability of the treatment.
- Quality of life and functional outcomes such as urine, bowel, and erectile function will be assessed with questionnaires.
- Up to 52 patients will be enrolled.
- Conditions
- Prostate Cancer, Prostatic Neoplasm
- Being tested
- 18F-DCFPyL, Tumor Irradiation, Prostate + tumor irradiation
- Keywords
- Image Guidance, Dose Escalation, Radiotherapy, Re-irradiation, Quality of Life
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-DCFPyLDrug
Also called 2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid
Participants will receive 2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid at baseline and 6 months after radiation. The maximum amount of injected active drug will be less than 4.02 micrograms. The target administered activity will be 6-6.5 mCi.
Tumor IrradiationRadiation
Also called SBRT
Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy.
Prostate + tumor irradiationRadiation
Also called SBRT
Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate.
Tumor IrradiationRadiation
Also called EBRT
External beam radiation therapy (EBRT): Participants with locally recurrent prostate cancer after treatment with EBRT. These participants cannot have had permanent brachytherapy as part of their treatment.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, Level 1, Arm 1: Tumor Irradiation | Experimental | Arm 1: Tumor irradiation.
Cohort 1, Level 1, Arm 1 - 40 gray (Gy) to Tumor planning target volume (PTV)
Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy.
External beam radiation therapy (EBRT): Participants with locally recurrent prostate cancer after treatment with EBRT. These participants cannot have had permanent brachytherapy as part of their treatment. Receives: Drug: 18F-DCFPyL; Radiation: Tumor Irradiation |
| Cohort 1, Level 2, Arm 1 - Tumor Irradiation | Experimental | Arm 1: Tumor irradiation.
Cohort 1, Level 2, Arm 1 - 42.5 gray (Gy) to Tumor planning target volume (PTV)
Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate.
External beam radiation therapy (EBRT): Participants with locally recurrent prostate cancer after treatment with EBRT. These participants cannot have had permanent brachytherapy as part of their treatment. Receives: Drug: 18F-DCFPyL; Radiation: Tumor Irradiation |
| Cohort 2, Level 1, Arm 2 - Prostate and Tumor Irradiation | Experimental | Arm 2: Prostate and tumor irradiation
Cohort 2, Level 1, Arm 2 - 30 gray (Gy) PTV to Prostate and 40 Gy to Tumor planning target volume (PTV)
Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate.
Brachytherapy: Participants with locally recurrent prostate cancer after treatment with brachytherapy +/- external beam radiation therapy (EBRT). These participants must have had brachytherapy as part of their treatment. Receives: Drug: 18F-DCFPyL; Radiation: Prostate + tumor irradiation; Radiation: Tumor Irradiation |
| Cohort 2, Level 2, Arm 2 - Prostate and Tumor Irradiation | Experimental | Arm 2: Prostate and tumor irradiation
Arm 2 - 30 gray (Gy) planning target volume (PTV) to Prostate and 42.5 Gy to Tumor PTV
Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate.
Brachytherapy: Participants with locally recurrent prostate cancer after treatment with brachytherapy +/- external beam radiation therapy (EBRT). These participants must have had brachytherapy as part of their treatment. Receives: Drug: 18F-DCFPyL; Radiation: Prostate + tumor irradiation; Radiation: Tumor Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
The MTD of image-guided, focally dose escalated prostate stereotactic body radiation therapy (SBRT) in participants with a local recurrence of prostate cancer after prior radiotherapy. The MTD is the dose level at which no more than 1 of up to 6 participants experience dose-limiting toxicity (DLT) during treatment and up to 3 weeks following completion of treatment, and the dose below that at which at least 2 (of .6) participants have DLT as a result of treatment. A DLT is a Grade 3 rectal, small bowel, or urinary toxicity that does not resolve to Grade 2 or less within 4 days, other Grade 3 in-field toxicities attributable to Stereotactic body radiation therapy (SBRT) that do not resolve to a Grade 2 or less within 4 days, and delays of more than one week in completing radiation treatment due to toxicity.
Measured: 3 weeks post-treatment
Secondary outcomes (7)
Sensitivity of 2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-Amino]-Pentyl}-Ureido)-Pentanedioic Acid (18F-DCFPyL) Imaging as Compared to Biopsy in Detecting Locally Recurrent Prostate Cancer
The sensitivity of DCF-PyL for detecting locally recurrent prostate cancer (at baseline) will be reported using biopsy as the gold standard to evaluate 18F-DCFPyL imaging as a method to detect locally recurrent prostate cancer after radiation. Sensitivity is the number of true positives divided by the sum of the number of true positives and false negatives. Lesions detected on DCF-PyL that are biopsy confirmed are considered true positives. Lesions that are not detected on DCFPyL and are biopsy positive are considered false negatives.
Measured: 6 months after radiation
Specificity of 2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-Amino]-Pentyl}-Ureido)-Pentanedioic Acid (18F-DCFPyL) Imaging as Compared to Biopsy in Detecting Locally Recurrent Prostate Cancer
The specificity of DCF-PyL for detecting locally recurrent prostate cancer (at baseline) will be reported using biopsy as the gold standard to evaluate 18F-DCFPyL imaging as a method to detect locally recurrent prostate cancer after radiation. Specificity is the number of true negatives divided by the sum of the number of true negatives and the number of false positives. Lesions that are not detected on DCF-PyL that are biopsy confirmed to have no tumor are considered true negatives. Lesions that are detected on DCF-PyL and are biopsy negative are considered false positives.
Measured: 6 months after radiation
Changes of Sexual Health Inventory for Men (SHIM) Quality of Life (QOL) Scores During and After Treatment
Changes of QOL scores during and after treatment of focally dose escalated prostate stereotactic body radiation therapy (SBRT) on participant reported outcomes (Sexual Health Inventory for Men (SHIM), in participants previously treated with radiotherapy. The QOL scores will be summarized at baseline and for each visit. Linear mixed effects model will be used to model quality of life scores at baseline and during and after treatment in which random intercept and random slope are used to account for participant-specific trajectory of QOL scores. The SHIM is a 5-question quiz used to identify erectile dysfunction and assess its severity. The composite score is generated by adding the score for each question. The total score can range from 1-25. Higer values represent better erectile function.
Measured: Baseline compared to 24 months after treatment
Changes of American Urologic Association (AUA) Symptom Index Quality of Life (QOL) Scores During and After Treatment
Changes of QOL scores during and after treatment of focally dose escalated prostate stereotactic body radiation therapy (SBRT) on participant reported outcomes, American Urologic Association (AUA) Symptom Index, in participants previously treated with radiotherapy. The QOL scores will be summarized at baseline and for each visit. Linear mixed effects model will be used to model quality of life scores at baseline and during and after treatment in which random intercept and random slope are used to account for participant-specific trajectory of QOL scores. The AUA Symptom Index is a 7-question quiz used to identify urinary symptoms and assess severity. Each question is scored based on the frequency of a different urinary symptoms. The composite score is generated by adding the score for each question. The total score can range from 0-35. Lower values represent less symptoms.
Measured: Baseline compared to 24 months after treatment
Changes of Expanded Prostate Cancer Index Composite (EPIC-26) Quality of Life (QOL) Scores During and After Treatment
Changes of QOL scores during and after treatment on participant reported outcomes, EPIC-26 in participants previously treated with radiotherapy. The QOL scores will be summarized at baseline and for each visit. Linear mixed effects model will be used to model QOL scores at baseline and during and after treatment in which random intercept and random slope are used to account for participant-specific trajectory of QOL scores. The EPIC-26 is a shortened, validated questionnaire used to assess health related QOL in individuals with prostate cancer. The EPIC-26 measures sexual function, bowel function, hormone therapy side effects, urinary incontinence, and urinary irritative symptoms. The survey has 26 individual items that have 4 to 5 response options that reflect a range of function from poor to excellent. The EPIC-26 uses a Likert scale for each item, and scores are transformed to a 0-100 scale, with higher scores indicating better Health-Related Quality of Life.
Measured: Baseline compared to 24 months after treatment
Biochemical Progression Free Survival (bPFS)
bPFS, prostate-specific antigen (PSA) < 2 ng/dL above post stereotactic body radiation therapy (SBRT) nadir) at 1 and 2 years after treatment with focally dose escalated SBRT for locally recurrent prostate cancer after irradiation: bPFS will be estimated by the Kaplan-Meier survival analysis and effects of clinical variables on bPFS will be assessed by the Cox proportional hazards model. bPFS is defined as the duration of time from start of treatment to time of PSA progression or death, whichever occurs first. PSA progression (also known as biochemical failure) is defined based on elevation of PSA 2 ng/dL beyond the post-treatment nadir PSA, using the Phoenix criteria.
Measured: 1 and 2 years after treatment
Dose Limiting Toxicities (DLT)
DLT's of image-guided, focally dose escalated prostate Stereotactic body radiation therapy (SBRT) in participants previously treated with radiotherapy. A DLT (during treatment and within the first three weeks after treatment) is defined as a Grade 3 rectal, small bowel, or urinary toxicity that does not resolve to Grade 2 or less within 4 days with appropriate medical management. Other grade 3 in-field toxicities attributable to SBRT that do not resolve to Grade 2 or less within 4 days with appropriate medical management. Delays of more than one week in completing radiation treatment due to toxicity. Toxicities were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 2 is moderate. Grade 3 is severe.
Define the dose-limiting toxicities and toxicity profile of image-guided, focally dose escalated prostate SBRT in patients previously treated with radiotherapy: DLTs will be reported descriptively.
Measured: 3 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start5 Jul 2018
- Primary completion3 May 2023
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Deborah Citrin, M.D., National Cancer Institute (NCI)
- Investigators
- Deborah E Citrin, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253744
- Sponsor's protocol ID
- 170153
- Other IDs
- 17-C-0153
- Status last verified
- Sep 2025
- First submitted
- 17 Aug 2017
- Last updated
- 8 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).
Publications
Patel KR, Rydzewski NR, Schott E, Cooley-Zgela T, Ning H, Cheng J, Salerno K, Huang EP, Lindenberg L, Mena E, Choyke P, Turkbey B, Citrin DE. A Phase 1 Trial of Salvage Stereotactic Body Radiation Therapy for Radiorecurrent Prostate Cancer After Brachytherapy. Int J Radiat Oncol Biol Phys. 2024 Aug 1;119(5):1471-1480. doi: 10.1016/j.ijrobp.2024.02.014. Epub 2024 Feb 29.
PubMed 38428681
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Image Guided Focally Dose Escalated Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy
- ClinicalTrials.gov ID
- NCT03253744
- Acronym / sponsor ID
- 170153
- Conditions
- Prostate Cancer, Prostatic Neoplasm
- Keywords
- Image Guidance, Dose Escalation, Radiotherapy, Re-irradiation, Quality of Life
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Posted 14 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Prostate cancer is the second leading cause of cancer death in United States (U.S.) men. Radiation is an effective treatment for most patients with localized prostate cancer, but sometimes the tumor returns. Researchers want to see if a highly focused type of radiation can help. It is given in only 5 treatments. It is called stereotactic body radiation therapy (SBRT).
Objective:
To study the maximum tolerated dose and side effects of stereotactic body radiation therapy in people with a local recurrence of prostate cancer after radiation.
Eligibility:
Men at least 18 years old who have recurrent prostate cancer after radiation therapy and no evidence of distant metastatic disease.
Design:
Participants will be screened with blood tests, physical exam, and medical history. They may also have:
Magnetic resonance imaging (MRI) scan of the prostate.
Positron emission tomography (PET)/computed tomography (CT) scan. Participants will get an injection of 2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid (18F-DCFPyL) for the PET scan. They will lie very still on their back on the scanner table.
Small samples of prostate tumor tissue will be taken by a needle through the skin or rectum to see if the cancer is in the prostate. Small metal seeds will be placed into the prostate at the same time to help guide the radiation.
About 2 weeks later, participants will have a radiation treatment planning CT scan.
Participants will answer questions about their urine function, bowel function, erectile function, and mood.
Participants will receive SBRT. They will have 5 radiation treatments over 2 weeks.
Participants will have follow-up visits. They will have a physical exam, blood tests, and questionnaires.
Six months after ending SBRT, the 18F-DCFPyL PET/CT will be repeated.
Participants will continue to have routine visits until two years after treatment is completed....
Detailed description
Background:
- Prostate cancer that recurs after prior radiation treatment can be challenging to cure due to the side effects of available treatments such as surgery and cryoablation.
- Re-irradiation with brachytherapy or stereotactic approaches has shown excellent rates of prostate cancer disease control with tolerable side effects.
- Using image guidance to allow highly conformal focal re-irradiation may potentially increase the efficacy of re-irradiation.
Objectives:
-Define the maximum tolerated dose (MTD) of image guided, focally dose escalated prostate radiation with stereotactic body radiation therapy (SBRT) in patients with a local recurrence of prostate cancer after prior radiotherapy.
Eligibility:
- Histological confirmation of recurrent prostate cancer after prior irradiation (external beam or brachytherapy)
- No evidence of distant metastases of prostate cancer
- No prior prostatectomy
- Subject is greater than or equal to18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).
Design:
- This is a Phase I trial of focal dose escalation with SBRT using image and pathologic guidance.
- Areas in the prostate shown to have tumor on biopsy or with advanced imaging studies will be treated with highly conformal SBRT over a period of two to three weeks. Treatment will be guided and gated by fiducials implanted in the prostate.
- Patients will be treated to escalating doses based on tolerability of the treatment.
- Quality of life and functional outcomes such as urine, bowel, and erectile function will be assessed with questionnaires.
- Up to 52 patients will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, Level 1, Arm 1: Tumor Irradiation | Experimental | Drug: 18F-DCFPyL, Radiation: Tumor IrradiationArm 1: Tumor irradiation. Cohort 1, Level 1, Arm 1 - 40 gray (Gy) to Tumor planning target volume (PTV) Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy. External beam radiation therapy (EBRT): Participants with locally recurrent prostate cancer after treatment with EBRT. These participants cannot have had permanent brachytherapy as part of their treatment. |
| Cohort 1, Level 2, Arm 1 - Tumor Irradiation | Experimental | Drug: 18F-DCFPyL, Radiation: Tumor IrradiationArm 1: Tumor irradiation. Cohort 1, Level 2, Arm 1 - 42.5 gray (Gy) to Tumor planning target volume (PTV) Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate. External beam radiation therapy (EBRT): Participants with locally recurrent prostate cancer after treatment with EBRT. These participants cannot have had permanent brachytherapy as part of their treatment. |
| Cohort 2, Level 1, Arm 2 - Prostate and Tumor Irradiation | Experimental | Drug: 18F-DCFPyL, Radiation: Prostate + tumor irradiation, Radiation: Tumor IrradiationArm 2: Prostate and tumor irradiation Cohort 2, Level 1, Arm 2 - 30 gray (Gy) PTV to Prostate and 40 Gy to Tumor planning target volume (PTV) Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate. Brachytherapy: Participants with locally recurrent prostate cancer after treatment with brachytherapy +/- external beam radiation therapy (EBRT). These participants must have had brachytherapy as part of their treatment. |
| Cohort 2, Level 2, Arm 2 - Prostate and Tumor Irradiation | Experimental | Drug: 18F-DCFPyL, Radiation: Prostate + tumor irradiation, Radiation: Tumor IrradiationArm 2: Prostate and tumor irradiation Arm 2 - 30 gray (Gy) planning target volume (PTV) to Prostate and 42.5 Gy to Tumor PTV Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate. Brachytherapy: Participants with locally recurrent prostate cancer after treatment with brachytherapy +/- external beam radiation therapy (EBRT). These participants must have had brachytherapy as part of their treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must have histologically confirmed locally recurrent adenocarcinoma of the prostate after prior radiation (external beam radiation therapy (EBRT) or brachytherapy).
- Prostate-specific antigen (PSA) failure after definitive radiation as defined by the Phoenix criteria (PSA elevation at least 2 nanograms (ng) per deciliter (dL) above post-radiotherapy nadir)
- Age greater than or equal to 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).
- Ability of subject to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (17 listed)
- Patients who are receiving any other investigational agents.
- PSA greater than or equal to 20 ng/dL if no prior 2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid (18F-DCFPyL) scan obtained (If PSA > 20 and 18F-DCFPyL obtained within 3 months prior to enrollment shows no evidence of metastatic disease, subjects may be included in the study)
- Biochemical recurrence within one year of completion of radiotherapy
- Need for chronic anticoagulation therapy (chronic low dose aspirin is not an exclusion)
- Pre-existing and ongoing radiation-related grade 3 bowel or bladder toxicity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-DCFPyLAlso: 2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acidParticipants will receive 2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid at baseline and 6 months after radiation. The maximum amount of injected active drug will be less than 4.02 micrograms. The target administered activity will be 6-6.5 mCi. | Drug | Cohort 1, Level 1, Arm 1: Tumor Irradiation, Cohort 1, Level 2, Arm 1 - Tumor Irradiation, Cohort 2, Level 1, Arm 2 - Prostate and Tumor Irradiation, Cohort 2, Level 2, Arm 2 - Prostate and Tumor Irradiation |
| Tumor IrradiationAlso: SBRTStereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy. | Radiation | Cohort 1, Level 1, Arm 1: Tumor Irradiation, Cohort 1, Level 2, Arm 1 - Tumor Irradiation |
| Prostate + tumor irradiationAlso: SBRTStereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate. | Radiation | Cohort 2, Level 1, Arm 2 - Prostate and Tumor Irradiation, Cohort 2, Level 2, Arm 2 - Prostate and Tumor Irradiation |
| Tumor IrradiationAlso: EBRTExternal beam radiation therapy (EBRT): Participants with locally recurrent prostate cancer after treatment with EBRT. These participants cannot have had permanent brachytherapy as part of their treatment. | Radiation | Cohort 1, Level 1, Arm 1: Tumor Irradiation, Cohort 1, Level 2, Arm 1 - Tumor Irradiation, Cohort 2, Level 1, Arm 2 - Prostate and Tumor Irradiation, Cohort 2, Level 2, Arm 2 - Prostate and Tumor Irradiation |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 3 weeks post-treatment
The MTD of image-guided, focally dose escalated prostate stereotactic body radiation therapy (SBRT) in participants with a local recurrence of prostate cancer after prior radiotherapy. The MTD is the dose level at which no more than 1 of up to 6 participants experience dose-limiting toxicity (DLT) during treatment and up to 3 weeks following completion of treatment, and the dose below that at which at least 2 (of .6) participants have DLT as a result of treatment. A DLT is a Grade 3 rectal, small bowel, or urinary toxicity that does not resolve to Grade 2 or less within 4 days, other Grade 3 in-field toxicities attributable to Stereotactic body radiation therapy (SBRT) that do not resolve to a Grade 2 or less within 4 days, and delays of more than one week in completing radiation treatment due to toxicity.
7 secondary outcomes
Sensitivity of 2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-Amino]-Pentyl}-Ureido)-Pentanedioic Acid (18F-DCFPyL) Imaging as Compared to Biopsy in Detecting Locally Recurrent Prostate Cancer
Time frame: 6 months after radiation
Specificity of 2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-Amino]-Pentyl}-Ureido)-Pentanedioic Acid (18F-DCFPyL) Imaging as Compared to Biopsy in Detecting Locally Recurrent Prostate Cancer
Time frame: 6 months after radiation
Changes of Sexual Health Inventory for Men (SHIM) Quality of Life (QOL) Scores During and After Treatment
Time frame: Baseline compared to 24 months after treatment
Changes of American Urologic Association (AUA) Symptom Index Quality of Life (QOL) Scores During and After Treatment
Time frame: Baseline compared to 24 months after treatment
Changes of Expanded Prostate Cancer Index Composite (EPIC-26) Quality of Life (QOL) Scores During and After Treatment
Time frame: Baseline compared to 24 months after treatment
Biochemical Progression Free Survival (bPFS)
Time frame: 1 and 2 years after treatment
Dose Limiting Toxicities (DLT)
Time frame: 3 weeks after end of treatment
Results and safety
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Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38428681Patel KR, Rydzewski NR, Schott E, Cooley-Zgela T, Ning H, Cheng J, Salerno K, Huang EP, Lindenberg L, Mena E, Choyke P, Turkbey B, Citrin DE. A Phase 1 Trial of Salvage Stereotactic Body Radiation Therapy for Radiorecurrent Prostate Cancer After Brachytherapy. Int J Radiat Oncol Biol Phys. 2024 Aug 1;119(5):1471-1480. doi: 10.1016/j.ijrobp.2024.02.014. Epub 2024 Feb 29.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah E Citrin, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 18F-DCFPyL, Tumor Irradiation and Prostate + tumor irradiation in people with Prostate Cancer and Prostatic Neoplasm, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: 3 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03253744, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.