A Phase 1 interventional study of 18F-DCFPyL and Tumor Irradiation in Prostate Cancer and Prostatic Neoplasm, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-08.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
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....
Background:
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:
Design:
EXCLUSION CRITERIA:
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.
Drug: 18F-DCFPyL · Radiation: Tumor Irradiation
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.
Drug: 18F-DCFPyL · Radiation: Tumor Irradiation
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.
Drug: 18F-DCFPyL · Radiation: Prostate + tumor irradiation · Radiation: Tumor Irradiation
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.
Drug: 18F-DCFPyL · Radiation: Prostate + tumor irradiation · Radiation: Tumor Irradiation
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.
Also known as: 2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid
Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy.
Also known as: 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.
Also known as: SBRT
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.
Also known as: EBRT
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.
Time frame: 3 weeks post-treatment
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.
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
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.
Time frame: 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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 3 weeks after end of treatment
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time frame: Date treatment consent signed to date off study, approximately 38 months (mos) & 26 days (d) for Cohort 1, Level 1, Arm 1, 29 mos & 9 d for Cohort 1, Level 2, Arm 1, 43 mos & 12 d for Cohort 2, Level 1, Arm 1, & 26 mos & 9 d for Cohort 2, Level 2, Arm 1.
| Milestone | Cohort 1, Level 1, Arm 1: 40 Gray (Gy) Tumor Irradiation Prostate and Tumor | Cohort 1, Level 2, Arm 1 - 42.5 Gray (Gy) Tumor Irradiation | Cohort 2, Level 1, Arm 2 - 30 Gray (Gy) and 40 Gy Prostate and Tumor Irradiation | Cohort 2, Level 2, Arm 2 - 30 Gray (Gy) and 42.5 Gy Prostate and Tumor Irradiation |
|---|---|---|---|---|
| Started | 6 | 2 | 3 | 6 |
| Completed | 6 | 2 | 3 | 6 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | Cohort 1, Level 1, Arm 1: 40 Gray (Gy) Tumor Irradiation Prostate and Tumor | Cohort 1, Level 2, Arm 1 - 42.5 Gray (Gy) Tumor Irradiation | Cohort 2, Level 1, Arm 2 - 30 Gray (Gy) and 40 Gy Prostate and Tumor Irradiation | Cohort 2, Level 2, Arm 2 - 30 Gray (Gy) and 42.5 Gy Prostate and Tumor Irradiation |
|---|---|---|---|---|
| Started | 6 | 2 | 3 | 6 |
| Completed | 6 | 2 | 3 | 6 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | Cohort 1, Level 1, Arm 1: 40 Gray (Gy) Tumor Irradiation Prostate and Tumor | Cohort 1, Level 2, Arm 1 - 42.5 Gray (Gy) Tumor Irradiation | Cohort 2, Level 1, Arm 2 - 30 Gray (Gy) and 40 Gy Prostate and Tumor Irradiation | Cohort 2, Level 2, Arm 2 - 30 Gray (Gy) and 42.5 Gy Prostate and Tumor Irradiation |
|---|---|---|---|---|
| Started | 6 | 2 | 3 | 6 |
| Completed | 4 | 2 | 3 | 2 |
| Not completed | 2 | 0 | 0 | 4 |
| Withdrew: Continuing follow-up. | 2 | 0 | 0 | 4 |
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.
| gray (Gy) | All Participants in Arm 1 | All Participants in Arm 2 |
|---|---|---|
| Maximum Tolerated Dose (MTD) | 40 | 42.5 |
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.
| Percent | All Participants in Arm 1 | All Participants in Arm 2 |
|---|---|---|
| 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 | 95 (82 to 99) | 100 (88 to 100) |
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.
| Percent | All Participants in Arm 1 | All Participants in Arm 2 |
|---|---|---|
| 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 | 100 (96 to 100) | 100 (96 to 100) |
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.
| Scores on a scale | All Participants in Arm 1 | All Participants in Arm 2 |
|---|---|---|
| Baseline | 7.25 ± 8.36 | 14.33 ± 10.44 |
| After treatment | 5.75 ± 7.61 | 6.71 ± 9.10 |
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.
| Scores on a scale | All Participants in Arm 1 | All Participants in Arm 2 |
|---|---|---|
| Baseline | 5.75 ± 5.48 | 8.77 ± 6.53 |
| After treatment | 11.86 ± 9.56 | 8.14 ± 3.98 |
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.
| Scores on a scale | All Participants in Arm 1 | All Participants in Arm 2 |
|---|---|---|
| Baseline | 93.75 ± 11.57 | 75.00 ± 25.00 |
| After treatment | 82.14 ± 27.82 | 71.43 ± 22.49 |
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.
| percentage of participants | All Participants in Arm 1 | All Participants in Arm 2 |
|---|---|---|
| 1 year after treatment | 100 | 100 |
| 2 years after treatment | 87.5 | 100 |
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.
| toxicities | All Participants in Arm 1 | All Participants in Arm 2 |
|---|---|---|
| Grade 3 Cystitis non-infective | 1 | 0 |
| Grade 3 Urinary incontinence | 1 | 0 |
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
| Participants | Cohort 1, Level 1, Arm 1: 40 Gray (Gy) Tumor Irradiation Prostate and Tumor | Cohort 1, Level 2, Arm 1 - 42.5 Gray (Gy) Tumor Irradiation | Cohort 2, Level 1, Arm 2 - 30 Gray (Gy) and 40 Gy Prostate and Tumor Irradiation | Cohort 2, Level 2, Arm 2 - 30 Gray (Gy) and 42.5 Gy Prostate and Tumor Irradiation |
|---|---|---|---|---|
| Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | 6 | 2 | 3 | 6 |
Collected over Date treatment consent signed to date off study, approximately 38 months and 26 days for Cohort 1, Level 1, Arm 1, 29 months and 9 days for Cohort 1, Level 2, Arm 1, 43 months and 12 days for Cohort 2, Level 1, Arm 1, and 26 months and 9 days for Cohort 2, Level 2, Arm 1.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1, Level 1, Arm 1: 40 Gray (Gy) Tumor Irradiation Prostate and Tumor | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| Cohort 1, Level 2, Arm 1 - 42.5 Gray (Gy) Tumor Irradiation | 0/2 (0%) | 1/2 (50%) | 2/2 (100%) |
| Cohort 2, Level 1, Arm 2 - 30 Gray (Gy) and 40 Gy Prostate and Tumor Irradiation | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Cohort 2, Level 2, Arm 2 - 30 Gray (Gy) and 42.5 Gy Prostate and Tumor Irradiation | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| Event | Cohort 1, Level 1, Arm 1: 40 Gray (Gy) Tumor Irradiation Prostate and Tumor | Cohort 1, Level 2, Arm 1 - 42.5 Gray (Gy) Tumor Irradiation | Cohort 2, Level 1, Arm 2 - 30 Gray (Gy) and 40 Gy Prostate and Tumor Irradiation | Cohort 2, Level 2, Arm 2 - 30 Gray (Gy) and 42.5 Gy Prostate and Tumor Irradiation |
|---|---|---|---|---|
| HematuriaRenal and urinary disorders | 0/6 | 1/2 | 0/3 | 0/6 |
| Event | Cohort 1, Level 1, Arm 1: 40 Gray (Gy) Tumor Irradiation Prostate and Tumor | Cohort 1, Level 2, Arm 1 - 42.5 Gray (Gy) Tumor Irradiation | Cohort 2, Level 1, Arm 2 - 30 Gray (Gy) and 40 Gy Prostate and Tumor Irradiation | Cohort 2, Level 2, Arm 2 - 30 Gray (Gy) and 42.5 Gy Prostate and Tumor Irradiation |
|---|---|---|---|---|
| Urinary incontinenceRenal and urinary disorders | 0/6 | 2/2 | 1/3 | 3/6 |
| Cystitis noninfectiveRenal and urinary disorders | 2/6 | 1/2 | 1/3 | 5/6 |
| DiarrheaGastrointestinal disorders | 0/6 | 0/2 | 2/3 | 3/6 |
| FatigueGeneral disorders | 3/6 | 1/2 | 0/3 | 4/6 |
| Fecal incontinenceGastrointestinal disorders | 0/6 | 0/2 | 2/3 | 0/6 |
| Urinary frequencyRenal and urinary disorders | 1/6 | 0/2 | 1/3 | 4/6 |
| Urinary tract obstructionRenal and urinary disorders | 0/6 | 0/2 | 2/3 | 1/6 |
| Urinary tract painRenal and urinary disorders | 2/6 | 1/2 | 2/3 | 1/6 |
| Anal painGastrointestinal disorders | 1/6 | 1/2 | 0/3 | 0/6 |
| AnemiaBlood and lymphatic system disorders | 1/6 | 1/2 | 0/3 | 0/6 |
| Age, Categorical(Participants) | Cohort 1, Level 1, Arm 1: 40 Gray (Gy) Tumor Irradiation Prostate and Tumor | Cohort 1, Level 2, Arm 1 - 42.5 Gray (Gy) Tumor Irradiation | Cohort 2, Level 1, Arm 2 - 30 Gray (Gy) and 40 Gy Prostate and Tumor Irradiation | Cohort 2, Level 2, Arm 2 - 30 Gray (Gy) and 42.5 Gy Prostate and Tumor Irradiation | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 0 | 0 | 2 | 3 |
| >=65 years | 5 | 2 | 3 | 4 | 14 |
| Age, Continuous(years) | Cohort 1, Level 1, Arm 1: 40 Gray (Gy) Tumor Irradiation Prostate and Tumor | Cohort 1, Level 2, Arm 1 - 42.5 Gray (Gy) Tumor Irradiation | Cohort 2, Level 1, Arm 2 - 30 Gray (Gy) and 40 Gy Prostate and Tumor Irradiation | Cohort 2, Level 2, Arm 2 - 30 Gray (Gy) and 42.5 Gy Prostate and Tumor Irradiation | Total |
|---|---|---|---|---|---|
| Mean | 71.02 ± 5.65 | 78.3 ± 5.66 | 72.7 ± 4.17 | 65.95 ± 4.51 | 70.38 ± 6.07 |
| Sex: Female, Male(Participants) | Cohort 1, Level 1, Arm 1: 40 Gray (Gy) Tumor Irradiation Prostate and Tumor | Cohort 1, Level 2, Arm 1 - 42.5 Gray (Gy) Tumor Irradiation | Cohort 2, Level 1, Arm 2 - 30 Gray (Gy) and 40 Gy Prostate and Tumor Irradiation | Cohort 2, Level 2, Arm 2 - 30 Gray (Gy) and 42.5 Gy Prostate and Tumor Irradiation | Total |
|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 |
| Male | 6 | 2 | 3 | 6 | 17 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1, Level 1, Arm 1: 40 Gray (Gy) Tumor Irradiation Prostate and Tumor | Cohort 1, Level 2, Arm 1 - 42.5 Gray (Gy) Tumor Irradiation | Cohort 2, Level 1, Arm 2 - 30 Gray (Gy) and 40 Gy Prostate and Tumor Irradiation | Cohort 2, Level 2, Arm 2 - 30 Gray (Gy) and 42.5 Gy Prostate and Tumor Irradiation | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 6 | 2 | 3 | 6 | 17 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cohort 1, Level 1, Arm 1: 40 Gray (Gy) Tumor Irradiation Prostate and Tumor | Cohort 1, Level 2, Arm 1 - 42.5 Gray (Gy) Tumor Irradiation | Cohort 2, Level 1, Arm 2 - 30 Gray (Gy) and 40 Gy Prostate and Tumor Irradiation | Cohort 2, Level 2, Arm 2 - 30 Gray (Gy) and 42.5 Gy Prostate and Tumor Irradiation | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 0 | 0 | 1 | 5 |
| White | 2 | 2 | 3 | 5 | 12 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Cohort 1, Level 1, Arm 1: 40 Gray (Gy) Tumor Irradiation Prostate and Tumor | Cohort 1, Level 2, Arm 1 - 42.5 Gray (Gy) Tumor Irradiation | Cohort 2, Level 1, Arm 2 - 30 Gray (Gy) and 40 Gy Prostate and Tumor Irradiation | Cohort 2, Level 2, Arm 2 - 30 Gray (Gy) and 42.5 Gy Prostate and Tumor Irradiation | Total |
|---|---|---|---|---|---|
| United States | 6 | 2 | 3 | 6 | 17 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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).
Supporting information: Study protocol, Sap, Icf
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