Prostatic NeoplasmsNCT01834001
Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
An observational study of Prostatic Neoplasms and Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Radiation is a common treatment for prostate cancer. It helps damage tumor cells and causes them to die. Radiation can be effective, but some tumors may be harder to treat with radiation or even with surgery. This happens to a small number of men who have either radiation or surgery for prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Prostatic Neoplasms, Prostate Cancer
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2013to 25 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with untreated prostate cancer and men with presumed prostate cancer relapse
Who may be able to join
- Patients must have histologically or cytologically confirmed prostate cancer. The outside pathology report is acceptable for study entry. Every effort will be made to acquire the outside pathology slides to be confirmed by the Laboratory of Pathology, NCI.
- Intermediate or high risk prostate cancer (clinical tumor stage T2b or higher, Gleason 7 or higher, or PSA greater than 10). Previously obtained MR imaging may be used for clinical T staging (extracapsular extension, seminal vesicle invasion).
- No prior local therapy (prostatectomy, radiation, cryotherapy) or hormonal therapy for prostate cancer.
- Age >18 years.
- ECOG performance status <2 (Karnofsky >60%).
- Radiotherapy is planned as definitive therapy for prostate cancer. For patients not treated at NCI ROB patients must have a radiation oncologist who is willing to collaborate with the ROB and provide documentation of treatment.
Show all 14Show fewer
- Ability of subject to understand and the willingness to sign a written informed consent document.
- INCLUSION CRITERIA: for men with presumed prostate cancer relapse
- Patients must have a history of histologically or cytologically confirmed prostate cancer. The outside pathology report is acceptable for study entry. Every effort will be made to acquire the outside pathology slides to be confirmed by the Laboratory of Pathology, NCI
- Age greater than or equal to 18 years.
- ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).
- Radiotherapy (external beam irradiation alone or in combination with hormonal therapy and/or brachytherapy) was delivered as definitive therapy for prostate cancer and documentation is available.
- Evidence of prostate cancer recurrence (biochemical relapse by the Phoenix definition, enlarging palpable prostatic abnormality, imaging evidence strongly suggestive of local failure)
- Ability of subject to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients unable to tolerate MRI (patients with pacemakers, cerebral aneurysm clips, shrapnel injuries, or other implantable electronic devices or metal not compatible with MRI).
- Evidence of metastases (pelvic lymph node involvement is not an exclusion criteria). For patients with recurrent prostate cancer, oligometastatic disease (3 or fewer visible metastases) is not an exclusion criterion.
- Patients with coagulopathies who are at increased risk for bleeding or on active anticoagulation therapy (platelets less than 100,000 per mm^3 or PT/PTT greater than 1.5 times the upper normal limit (UNL). Patients are eligible if the underlying cause is correctable.
- Subject s weight exceeding MRI or radiation treatment table tolerance.
- Patients with active urinary tract infections.
- Patients with renal insufficiency with a GFR less than 30, due to the fact that they will not be able to undergo gadolinium enhanced MRI.
Show all 9Show fewer
- Uncontrolled illness or comorbidity that in the judgment of the PI would preclude participation in the study.
- Hepatitis B or Hepatitis C active infection.
- HIV-positive patients are ineligible because HIV is known to increase radiation toxicity and may result in under-dosing or alterations in the treatment plan that would alter the likelihood of local recurrence. Appropriate studies will be undertaken in HIV positive patients when indicated.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of Local Response of Prostate Cancer to Irradiation Using Multiparametric MRI and MR-Guided Biopsies
Background:
- Radiation is a common treatment for prostate cancer. It helps damage tumor cells and causes them to die. Radiation can be effective, but some tumors may be harder to treat with radiation or even with surgery. This happens to a small number of men who have either radiation or surgery for prostate cancer. Most men who have these hard-to-treat tumors do not know if the tumor has recurred only in the prostate or has spread to another area. Also, men whose prostate cancer has recurred only after radiation may have different treatment options. This study will use improved imaging studies to better understand why some men do not respond as well to initial radiation treatments.
Read more
Objectives:
- To use detailed imaging studies to look at the results of local radiation therapy for prostate cancer.
Eligibility:
- Men at least 18 years of age who are scheduled to have radiation for prostate cancer.
- Men at least 18 years of age whose prostate cancer has returned after earlier treatments.
Design:
- All participants will have a medical history and physical exam. Blood and urine samples will be collected. Imaging studies will be used to evaluate the cancer at the start of the study.
- All participants will have an initial full magnetic resonance imaging (MRI) scan of the prostate. Tumor and healthy tissue samples will be collected.
- Those whose cancer has recurred after treatment will discuss possible treatment options with the study doctors.
- Participants who are scheduled to have radiation will have radiation therapy. This will be given according to the current standard of treatment.
- After radiation, participants will have regular follow-up tests and imaging studies. They will have another full MRI scan 6 months after the end of radiation treatment.
Read the detailed description
Background:
Radiation therapy is a commonly used therapy for prostate cancers. The majority of men with prostate cancer will be cured by therapy; however, a subset, typically men with bulky or higher risk disease will develop PSA failure after definitive radiotherapy.
Currently, men with a rising PSA after radiotherapy may receive hormonal therapy or may undergo further evaluation for local failure.
It is not known how many men with rising PSA after radiotherapy may have a local failure and would benefit from a salvage local therapy. With the availability of a growing number of local salvage options, accurately defining the presence and characteristics of local failure is critical.
Objective:
To determine the rate of local recurrence in patients with prostate cancer treated with radiotherapy using multiparametric prostate MR guided and standard biopsies.
Eligibility:
Patients with no local therapy for prostate cancer:
Age >= 18 years.
Histologically confirmed adenocarcinoma of the prostate.
Intermediate or high risk prostate cancer (clinical stage >=T2b, Gleason score 7 or higher, or PSA >10, extracapsular extension or seminal vesicle invasion on MRI).
Patient will be treated with radiotherapy for prostate cancer.
ECOG performance status <=2.
Patients with biochemical relapse after radiotherapy for prostate cancer:
Evidence of prostate cancer recurrence (palpable abnormality after radiotherapy, radiographic evidence of local failure, biochemical relapse).
ECOG performance status <=2.
Age >= 18 years.
Histologically confirmed adenocarcinoma of the prostate.
Design:
Patients with untreated prostate cancer:
Participants will be screened with a physical examination, medical history, laboratory tests (CBC, chemistries, liver transaminases, PSA, PT/PTT), and imaging studies (as appropriate to staging).
Patients will undergo multiparametric MR imaging and MR guided prostate biopsy of all suspicious lesions (diagnostic and research).
Patients will receive radiotherapy at NIH or at an outside facility.
Patients will return for follow up at 3 month intervals for the first 2 years and then every six months for 5 years for PSA measurement.
Patients will undergo a multiparametric MR at 6 months after therapy. No biopsy is obtained unless patients meet the definition of treatment failure. This study would allow future correlation with early changes that may predict for eventual outcome.
Patients with a rising PSA that meet the criteria for biochemical failure by the Phoenix definition will undergo repeat multiparametric prostate MRI with biopsy of suspicious lesions (diagnostic and research).
Patients with recurrent prostate cancer:
Participants will be screened with a physical examination, medical history, laboratory tests (CBC, chemistries, Liver transaminases, PSA, PT/PTT), and imaging studies.
Patients will undergo multiparametric MR imaging and MR guided prostate biopsy of all suspicious lesions (diagnostic and research).
120 patients with untreated prostate cancer and 100 patients with biochemical recurrence after radiotherapy will be accrued to this study.
- Conditions
- Prostatic Neoplasms, Prostate Cancer
- Keywords
- Prostatic Neoplasms, Radiation, Biochemical Failure, Natural History
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1/Untreated prostate cancer | Patients with untreated prostate cancer | |
| 2/Radiotherapy treated prostate cancer | Patients with prostate cancer who have already received definitive radiotherapy and have experienced biochemical failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the rate of local recurrence in patients with prostate cancer treated with radiotherapy using multiparametric prostate MR -guided and standard biopsies.
The primary objective is to determine the rate of local recurrence in patients with intermediate and high risk prostate cancer treated with radiotherapy that develop a rising PSA.
Measured: completion of study
Secondary outcomes (6)
Post-treatment Multiparametric MR imaging
To determine if post-treatment multiparametric MR imaging correlates with treatment effect or pathologic grade on biopsy
Measured: completion of study
MR images at failure
To compare MR images obtained at failure to whole mount prostate pathology in patients who undergo eventual salvage prostatectomy
Measured: completion of study
Local failure detection
To determine if prostate MR and MR-guided biopsies enhance the ability to detect local failure after radiation compared to standard biopsy alone.
Measured: completion of study
clinical and radiographic predictors of local recurrence
To determine the pre-treatment clinical and radiographic predictors of local recurrence in intermediate and high risk prostate cancer patients treated with radiotherapy
Measured: completion of study
Changes in tumor tissue
To evaluate changes in tumor tissue from post-radiotherapy recurrence compared to pre-treatment biopsies with the goal of defining factors of radiation resistance
Measured: completion of study
Biologic predictors of local recurrence
To define biologic predictors of local recurrence in intermediate and high risk prostate cancer patients treated with radiotherapy
Measured: completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study start13 Nov 2013
- Primary completion25 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Deborah E Citrin, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834001
- Sponsor's protocol ID
- 130119
- Other IDs
- 13-C-0119
- Status last verified
- 4 Nov 2026
- First submitted
- 13 Apr 2013
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All 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 dbGaP.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Local Response of Prostate Cancer to Irradiation Using Multiparametric MRI and MR-Guided Biopsies
- ClinicalTrials.gov ID
- NCT01834001
- Acronym / sponsor ID
- 130119
- Conditions
- Prostatic Neoplasms, Prostate Cancer
- Keywords
- Prostatic Neoplasms, Radiation, Biochemical Failure, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 13 Nov 2013 (actual)
- Primary completion
- 25 Feb 2027 (estimated)
- First posted
- 17 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Radiation is a common treatment for prostate cancer. It helps damage tumor cells and causes them to die. Radiation can be effective, but some tumors may be harder to treat with radiation or even with surgery. This happens to a small number of men who have either radiation or surgery for prostate cancer. Most men who have these hard-to-treat tumors do not know if the tumor has recurred only in the prostate or has spread to another area. Also, men whose prostate cancer has recurred only after radiation may have different treatment options. This study will use improved imaging studies to better understand why some men do not respond as well to initial radiation treatments.
Objectives:
- To use detailed imaging studies to look at the results of local radiation therapy for prostate cancer.
Eligibility:
- Men at least 18 years of age who are scheduled to have radiation for prostate cancer.
- Men at least 18 years of age whose prostate cancer has returned after earlier treatments.
Design:
- All participants will have a medical history and physical exam. Blood and urine samples will be collected. Imaging studies will be used to evaluate the cancer at the start of the study.
- All participants will have an initial full magnetic resonance imaging (MRI) scan of the prostate. Tumor and healthy tissue samples will be collected.
- Those whose cancer has recurred after treatment will discuss possible treatment options with the study doctors.
- Participants who are scheduled to have radiation will have radiation therapy. This will be given according to the current standard of treatment.
- After radiation, participants will have regular follow-up tests and imaging studies. They will have another full MRI scan 6 months after the end of radiation treatment.
Detailed description
Background:
Radiation therapy is a commonly used therapy for prostate cancers. The majority of men with prostate cancer will be cured by therapy; however, a subset, typically men with bulky or higher risk disease will develop PSA failure after definitive radiotherapy.
Currently, men with a rising PSA after radiotherapy may receive hormonal therapy or may undergo further evaluation for local failure.
It is not known how many men with rising PSA after radiotherapy may have a local failure and would benefit from a salvage local therapy. With the availability of a growing number of local salvage options, accurately defining the presence and characteristics of local failure is critical.
Objective:
To determine the rate of local recurrence in patients with prostate cancer treated with radiotherapy using multiparametric prostate MR guided and standard biopsies.
Eligibility:
Patients with no local therapy for prostate cancer:
Age >= 18 years.
Histologically confirmed adenocarcinoma of the prostate.
Intermediate or high risk prostate cancer (clinical stage >=T2b, Gleason score 7 or higher, or PSA >10, extracapsular extension or seminal vesicle invasion on MRI).
Patient will be treated with radiotherapy for prostate cancer.
ECOG performance status <=2.
Patients with biochemical relapse after radiotherapy for prostate cancer:
Evidence of prostate cancer recurrence (palpable abnormality after radiotherapy, radiographic evidence of local failure, biochemical relapse).
ECOG performance status <=2.
Age >= 18 years.
Histologically confirmed adenocarcinoma of the prostate.
Design:
Patients with untreated prostate cancer:
Participants will be screened with a physical examination, medical history, laboratory tests (CBC, chemistries, liver transaminases, PSA, PT/PTT), and imaging studies (as appropriate to staging).
Patients will undergo multiparametric MR imaging and MR guided prostate biopsy of all suspicious lesions (diagnostic and research).
Patients will receive radiotherapy at NIH or at an outside facility.
Patients will return for follow up at 3 month intervals for the first 2 years and then every six months for 5 years for PSA measurement.
Patients will undergo a multiparametric MR at 6 months after therapy. No biopsy is obtained unless patients meet the definition of treatment failure. This study would allow future correlation with early changes that may predict for eventual outcome.
Patients with a rising PSA that meet the criteria for biochemical failure by the Phoenix definition will undergo repeat multiparametric prostate MRI with biopsy of suspicious lesions (diagnostic and research).
Patients with recurrent prostate cancer:
Participants will be screened with a physical examination, medical history, laboratory tests (CBC, chemistries, Liver transaminases, PSA, PT/PTT), and imaging studies.
Patients will undergo multiparametric MR imaging and MR guided prostate biopsy of all suspicious lesions (diagnostic and research).
120 patients with untreated prostate cancer and 100 patients with biochemical recurrence after radiotherapy will be accrued to this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/Untreated prostate cancer | – | –Patients with untreated prostate cancer |
| 2/Radiotherapy treated prostate cancer | – | –Patients with prostate cancer who have already received definitive radiotherapy and have experienced biochemical failure |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with untreated prostate cancer and men with presumed prostate cancer relapse
Key inclusion criteria (14 listed)
- INCLUSION CRITERIA: for men with presumed prostate cancer relapse
- Patients must have a history of histologically or cytologically confirmed prostate cancer. The outside pathology report is acceptable for study entry. Every effort will be made to acquire the outside pathology slides to be confirmed by the Laboratory of Pathology, NCI
- Age greater than or equal to 18 years.
- ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).
- Radiotherapy (external beam irradiation alone or in combination with hormonal therapy and/or brachytherapy) was delivered as definitive therapy for prostate cancer and documentation is available.
Key exclusion criteria (9 listed)
- Patients unable to tolerate MRI (patients with pacemakers, cerebral aneurysm clips, shrapnel injuries, or other implantable electronic devices or metal not compatible with MRI).
- Evidence of metastases (pelvic lymph node involvement is not an exclusion criteria). For patients with recurrent prostate cancer, oligometastatic disease (3 or fewer visible metastases) is not an exclusion criterion.
- Patients with coagulopathies who are at increased risk for bleeding or on active anticoagulation therapy (platelets less than 100,000 per mm^3 or PT/PTT greater than 1.5 times the upper normal limit (UNL). Patients are eligible if the underlying cause is correctable.
- Subject s weight exceeding MRI or radiation treatment table tolerance.
- Patients with active urinary tract infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the rate of local recurrence in patients with prostate cancer treated with radiotherapy using multiparametric prostate MR -guided and standard biopsies.
Time frame: completion of study
The primary objective is to determine the rate of local recurrence in patients with intermediate and high risk prostate cancer treated with radiotherapy that develop a rising PSA.
6 secondary outcomes
Post-treatment Multiparametric MR imaging
Time frame: completion of study
MR images at failure
Time frame: completion of study
Local failure detection
Time frame: completion of study
clinical and radiographic predictors of local recurrence
Time frame: completion of study
Changes in tumor tissue
Time frame: completion of study
Biologic predictors of local recurrence
Time frame: completion of study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All 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 dbGaP.
Related trials for Prostatic Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
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?
An observational study of Prostatic Neoplasms and Prostate Cancer, 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 14 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rukayat O Salau ((240) 858-3712, rukayat.salau@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the rate of local recurrence in patients with prostate cancer treated with radiotherapy using multiparametric prostate MR -guided and standard biopsies. (time frame: completion of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2026.