Recurrent Prostate CancerPhase 1NCT01923506
Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer After Undergoing Surgery
A Phase 1 study testing stereotactic body radiation therapy, quality-of-life assessment and laboratory biomarker analysis in people with Recurrent Prostate Cancer and Stage I Prostate Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This phase I trial studies the side effects and best dose of stereotactic body radiation therapy in treating patients with prostate cancer after undergoing surgery. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer
- What is being tested?
- stereotactic body radiation therapy, quality-of-life assessment and laboratory biomarker analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2013to 28 Jun 2027
- Phase
- Phase 1
- 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 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of diagnosis of prostate cancer after undergoing prostatectomy
- No evidence of regional nodal or distant metastases based on computed tomography (CT) abdomen and pelvis and whole body bone scan within 120 days prior to study entry; nodes less than 1.5 cm will be considered reactive and biopsy is not required; nodes 1.5 cm or larger are required to undergo biopsy and be negative prior to study registration; bone scan findings in the absence of blastic or lytic lesion correlates on CT imaging will also be deemed non-neoplastic
- Eastern Cooperative Oncology Group (ECOG) performance scale 0-2
- Child bearing potential: In this patient population, this pertains to the ability to conceive a child; eligible patients already have received prostatectomy, and therefore this risk is not applicable
- Prostate specific antigen (PSA) value can be undetectable up to a value of 2.0 within 30 days prior to study entry
- PSA value that is undetectable can be enrolled if pathology from prostatectomy demonstrates one or more of the following: positive margin, extracapsular extension, or seminal vesicle invasion
- All subjects must have the ability to understand and the willingness to sign a written informed consent
Who cannot join
- Patients should not have any uncontrolled illness including ongoing or active infection
- Patients may not be receiving any other investigational agents, or concurrent biological chemotherapy
- Patients with history of prior malignancies (with exception to non-melanoma skin cancer) are ineligible for this study, unless they are documented to be disease-free for at least 5 years
- Study-specific exclusions:
- History of prior radiation to the pelvis
- History of uncontrolled inflammatory bowel disease
- Unable to comply with radiation therapy procedures
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Stereotactic Body Radiation Therapy to the Prostate Fossa: Phase I Dose Escalation Study
This phase I trial studies the side effects and best dose of stereotactic body radiation therapy in treating patients with prostate cancer after undergoing surgery. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the maximum tolerated dose (MTD) with an upper limit of 45 Gray (Gy) in 5 fractions, in the delivery of stereotactic body radiation therapy (SBRT) to the prostate fossa.
SECONDARY OBJECTIVES:
- To assess acute and late toxicities from treatment.
II. To assess biochemical progression-free survival.
III. To collect prospective quality-of-life data related to bowel, urinary, and sexual health.
OUTLINE: This is a dose-escalation study.
Patients receive 5 fractions of SBRT over 1.5 weeks.
After completion of study treatment, patients are followed up at 90 days and then periodically for 3 years.
- Conditions
- Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer
- Being tested
- stereotactic body radiation therapy, quality-of-life assessment, laboratory biomarker analysis
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic body radiation therapyRadiation
Also called SBRT, stereotactic radiation therapy, stereotactic radiotherapy
Undergo SBRT
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (SBRT) | Experimental | Patients receive 5 fractions of SBRT over 1.5 weeks. Receives: Radiation: stereotactic body radiation therapy; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD, defined as the highest dose tested in which fewer than 33% of patients experienced dose limiting toxicity, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Tables will be created to summarize these toxicities and side effects by dose level.
Measured: 90 days
Secondary outcomes (4)
Incidence of acute toxicities observed at each dose level graded according to the NCI CTCAE version 4.0
Tables will be created to summarize these toxicities and side effects by dose level.
Measured: Up to 90 days
Incidence of late toxicities observed at each dose level graded according to the NCI CTCAE version 4.0
Tables will be created to summarize these toxicities and side effects by dose level.
Measured: Up to 3 years
Biochemical progression-free survival
Estimated using Kaplan-Meier. 95% confidence intervals should be provided.
Measured: Up to 3 years
Prospective quality-of-life data related to bowel, urinary, and sexual health using the numerical scores generated from the patient questionnaires
Quality of life questionnaires include the International Prostate Symptom Scale (IPSS), sexual health inventory for men (SHIM), and Merrick rectal function scale.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2013 (estimated)
- Study start25 Nov 2013
- Primary completion28 Jun 2027 (estimated)
- Study completion28 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Prostate CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sagus Sampath, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923506
- Sponsor's protocol ID
- 13257
- Other IDs
- NCI-2013-01613, 13257
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2013
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiation Therapy to the Prostate Fossa: Phase I Dose Escalation Study
- ClinicalTrials.gov ID
- NCT01923506
- Acronym / sponsor ID
- 13257
- Conditions
- Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Nov 2013 (actual)
- Primary completion
- 28 Jun 2027 (estimated)
- Study completion
- 28 Jun 2027 (estimated)
- First posted
- 15 Aug 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.
This phase I trial studies the side effects and best dose of stereotactic body radiation therapy in treating patients with prostate cancer after undergoing surgery. Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
Detailed description
PRIMARY OBJECTIVES:
- To determine the maximum tolerated dose (MTD) with an upper limit of 45 Gray (Gy) in 5 fractions, in the delivery of stereotactic body radiation therapy (SBRT) to the prostate fossa.
SECONDARY OBJECTIVES:
- To assess acute and late toxicities from treatment.
II. To assess biochemical progression-free survival.
III. To collect prospective quality-of-life data related to bowel, urinary, and sexual health.
OUTLINE: This is a dose-escalation study.
Patients receive 5 fractions of SBRT over 1.5 weeks.
After completion of study treatment, patients are followed up at 90 days and then periodically for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (SBRT) | Experimental | Radiation: stereotactic body radiation therapy, Procedure: quality-of-life assessment, Other: laboratory biomarker analysisPatients receive 5 fractions of SBRT over 1.5 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- History of diagnosis of prostate cancer after undergoing prostatectomy
- No evidence of regional nodal or distant metastases based on computed tomography (CT) abdomen and pelvis and whole body bone scan within 120 days prior to study entry; nodes less than 1.5 cm will be considered reactive and biopsy is not required; nodes 1.5 cm or larger are required to undergo biopsy and be negative prior to study registration; bone scan findings in the absence of blastic or lytic lesion correlates on CT imaging will also be deemed non-neoplastic
- Eastern Cooperative Oncology Group (ECOG) performance scale 0-2
- Child bearing potential: In this patient population, this pertains to the ability to conceive a child; eligible patients already have received prostatectomy, and therefore this risk is not applicable
- Prostate specific antigen (PSA) value can be undetectable up to a value of 2.0 within 30 days prior to study entry
Key exclusion criteria (8 listed)
- Patients should not have any uncontrolled illness including ongoing or active infection
- Patients may not be receiving any other investigational agents, or concurrent biological chemotherapy
- Patients with history of prior malignancies (with exception to non-melanoma skin cancer) are ineligible for this study, unless they are documented to be disease-free for at least 5 years
- Study-specific exclusions:
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
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 |
|---|---|---|
| stereotactic body radiation therapyAlso: SBRT, stereotactic radiation therapy, stereotactic radiotherapyUndergo SBRT | Radiation | Treatment (SBRT) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Treatment (SBRT) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (SBRT) |
Primary outcome
MTD, defined as the highest dose tested in which fewer than 33% of patients experienced dose limiting toxicity, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: 90 days
Tables will be created to summarize these toxicities and side effects by dose level.
4 secondary outcomes
Incidence of acute toxicities observed at each dose level graded according to the NCI CTCAE version 4.0
Time frame: Up to 90 days
Incidence of late toxicities observed at each dose level graded according to the NCI CTCAE version 4.0
Time frame: Up to 3 years
Biochemical progression-free survival
Time frame: Up to 3 years
Prospective quality-of-life data related to bowel, urinary, and sexual health using the numerical scores generated from the patient questionnaires
Time frame: Up to 3 years
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 1 Sep 2026.
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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.
Sagus Sampath principal investigator
City of Hope Medical Center
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 stereotactic body radiation therapy, quality-of-life assessment and laboratory biomarker analysis in people with Recurrent Prostate Cancer and Stage I Prostate Cancer, run by City of Hope Medical Center 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 7 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 1 Sep 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.
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?
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?
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?
MTD, defined as the highest dose tested in which fewer than 33% of patients experienced dose limiting toxicity, graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (time frame: 90 days). 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 1 Sep 2026.