Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy
Phase I Trial of Image Guided Focally Dose Escalated Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy
2 other identifiers
interventional
17
1 country
1
Brief 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. 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....
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 prostate-cancer
Started Jul 2018
Longer than P75 for phase_1 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2017
CompletedFirst Posted
Study publicly available on registry
August 18, 2017
CompletedStudy Start
First participant enrolled
July 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2023
CompletedResults Posted
Study results publicly available
November 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2025
CompletedOctober 8, 2025
September 1, 2025
4.8 years
August 17, 2017
October 18, 2023
September 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
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
6 months after radiation
Changes of Sexual Health Inventory for Men (SHIM) Quality of Life (QOL) Scores During and After Treatment
Baseline compared to 24 months after treatment
Changes of American Urologic Association (AUA) Symptom Index Quality of Life (QOL) Scores During and After Treatment
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
Baseline compared to 24 months after treatment
- +2 more secondary outcomes
Other Outcomes (1)
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
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.
Study Arms (4)
Cohort 1, Level 1, Arm 1: Tumor Irradiation
EXPERIMENTALArm 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
EXPERIMENTALArm 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
EXPERIMENTALArm 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
EXPERIMENTALArm 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.
Interventions
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.
Stereotactic body radiation therapy (SBRT) will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- Pre-existing and ongoing radiation-related grade 3 bowel or bladder toxicity
- Inflammatory bowel disease
- Active Lupus or Active scleroderma
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Deborah E. Citrin
- Organization
- National Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah E Citrin, M.D.
National Cancer Institute (NCI)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- NIH
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 17, 2017
First Posted
August 18, 2017
Study Start
July 5, 2018
Primary Completion
May 3, 2023
Study Completion
January 30, 2025
Last Updated
October 8, 2025
Results First Posted
November 14, 2023
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.
- Access Criteria
- Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.
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).