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NCT03525262 · ClinicalTrials.gov registry record · Phase 2
Prostate Oncologic Therapy While Ensuring Neurovascular Conservation (POTEN-C)
A Phase 2 study of Prostate Cancer (Adenocarcinoma), sponsored by University of Texas Southwestern Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 124
- Enrollment target
- 8
- Study locations
NCT03525262 is a Phase 2 study of Prostate Cancer (Adenocarcinoma) that is active but no longer recruiting, run by University of Texas Southwestern Medical Center. The registered enrollment target is 124 participants, roughly in line with the 121-participant average among 13 other Prostate Cancer (Adenocarcinoma) trials with a reported enrollment target. The trial reports 8 study locations across 7 states.
The verdict
NCT03525262, a Phase 2 study of Prostate Cancer (Adenocarcinoma), is active but no longer recruiting, sponsored by University of Texas Southwestern Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 124 participants
- Enrollment target
- 8
- Study locations
Study Summary
Reduction of dose to or 'sparing' of neurovascular structures during stereotactic ablative body radiotherapy (SAbR) for localized prostate cancer will improve retention of sexual potency, while retaining excellent oncologic control and other secondary health-related quality of life (HRQOL) endpoints. Primary Objectives: • To compare the decline in patient health-related quality of life (HRQOL) instrument-defined erectile dysfunction following stereotactic ablative body radiotherapy (SAbR) with or without neurovascular sparing Secondary Objectives: * Assess acute (within 3 months of treatment) and chronic (\>3 months after treatment) SAbR related GU and GI toxicities, as well as serial impact on HRQOL metrics over time * Assess biochemical progression free survival, local recurrence, distant recurrence, and survival * Evaluate simplified 'practical' secondary HRQOL sexual potency endpoints that can be compared to prior literature. Exploratory Objectives: * Evaluate feasibility of MRI BOLD/TOLD to be integrated as hypoxia monitoring sequences to standard already planned diagnostic and/or treatment planning MRI on the study in five patient pilot. * Evaluate quality of spacer placement and its effect on dose to neurovascular structures * Evaluate rate local recurrence in the area of sparing adjacent to the neurovascular elements by biopsy in those with biochemical progression.
Conditions Studied
Interventions
- RADIATION 30Gy (Gray) planning target volume (PTV)
Study Locations (8)
Colorado
- University of Colorado Hospital - Aurora
- Penrose Hospital - Colorado Springs
California
- UCSF ( Department of Radiation Oncology University of California San Francisco) - San Francisco
Michigan
- University of Michigan- Michigan Medicine - Ann Arbor
New York
- Stony Brook University Cancer Center - Stony Brook
Ohio
- Cleveland Clinic - Cleveland
Pennsylvania
- Penn Medicine Radiation Oncology - Philadelphia
Texas
- UT Southwestern Cancer Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2018-04-24 |
| Est. Completion | 2029-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03525262
The ClinicalTrials.gov registry entry for NCT03525262 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 121-participant average among 13 other Prostate Cancer (Adenocarcinoma) trials with a reported enrollment target. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prostate Cancer (Adenocarcinoma) appearing as the primary indexed condition, and to 1 intervention - of which 30Gy (Gray) planning target volume (PTV) is the first listed.
NCT03525262 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Colorado, California, Michigan.
Frequently Asked Questions
What is clinical trial NCT03525262 about?
NCT03525262 is a clinical study titled "Prostate Oncologic Therapy While Ensuring Neurovascular Conservation (POTEN-C)". Reduction of dose to or 'sparing' of neurovascular structures during stereotactic ablative body radiotherapy (SAbR) for localized prostate cancer will improve retention of sexual potency, while retaining excellent oncologic control and other secondary health-related quality of life (HRQOL) endpoints...
What is the current status of trial NCT03525262?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2018-04-24. Estimated completion is 2029-04.
What conditions does trial NCT03525262 study?
This clinical trial studies the following conditions: Prostate Cancer (Adenocarcinoma).
What interventions are being tested in trial NCT03525262?
The interventions under investigation include: 30Gy (Gray) planning target volume (PTV) (RADIATION).
Who is sponsoring clinical trial NCT03525262?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03525262 being conducted?
This trial has 8 study locations across California, Colorado, Michigan, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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