Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 2 study of Prostate Cancer (Adenocarcinoma), sponsored by University of Texas Southwestern Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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. The Expanded Prostate Cancer Index Composite (EPIC) health-related quality of life (HRQOL) instrument includes four sub-scales like urinary function, bowel habits, sexual function, and hormonal function. The primary outcome (sexual function) which has a range score of 0-100 from 9 questions
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 |
What the registry record for NCT03525262 still lists
NCT03525262 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 121-participant average among 13 other Prostate Cancer (Adenocarcinoma) trials with a reported enrollment target.
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 lists 8 locations in 7 states (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.
Learn More About Clinical Trials
Similar trials for Prostate Cancer (Adenocarcinoma)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03525262's enrollment target sits among peer trials
124 3rd of 13 higher than 11 of 13 other Prostate Cancer (Adenocarcinoma) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer (Adenocarcinoma) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer
RECRUITING · Phase 2
-
Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer
RECRUITING · Phase 2
-
A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec
RECRUITING · Phase 2
-
Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy
RECRUITING · Phase 2
-
A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate
RECRUITING · Phase 2
-
Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02523014 · 124 participants · Phase 2
Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas
- NCT02670707 · 124 participants · Phase 3
Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)
- NCT02830724 · 124 participants · Phase 1
Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers
- NCT04748809 · 124 participants · NA
Effect of Anti-inflammatory Diet in Rheumatoid Arthritis
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI