Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy
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ClinicalTrials.gov Identifier: NCT03253744 |
Recruitment Status :
Recruiting
First Posted : August 18, 2017
Last Update Posted : October 19, 2020
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Tracking Information | |||||
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First Submitted Date ICMJE | August 17, 2017 | ||||
First Posted Date ICMJE | August 18, 2017 | ||||
Last Update Posted Date | October 19, 2020 | ||||
Actual Study Start Date ICMJE | July 5, 2018 | ||||
Estimated Primary Completion Date | June 20, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Maximum tolerated dose [ Time Frame: 3 weeks post-treatment ] Define the MTD of imageguided, focally dose escalated prostate SBRT in patients with a local recurrence of prostate cancer after priorradiotherapy.
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Original Primary Outcome Measures ICMJE |
Maximum tolerated dose [ Time Frame: 3 weeks post-treatment ] | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy | ||||
Official Title ICMJE | Phase I Trial of Image Guided Focally Dose Escalated Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy | ||||
Brief Summary | Background: Prostate cancer is the second leading cause of cancer death in 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.. PET/CT scan. Participants will get an injection of 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. Participantes will continue to have routine visits until two years after treatment is completed.... |
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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 reirradiation 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:
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
52 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 20, 2024 | ||||
Estimated Primary Completion Date | June 20, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
EXCLUSION CRITERIA:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03253744 | ||||
Other Study ID Numbers ICMJE | 170153 17-C-0153 |
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Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ) | ||||
Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | National Institutes of Health Clinical Center (CC) | ||||
Verification Date | October 15, 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |