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Prostate Oncologic Therapy While Ensuring Neurovascular Conservation (POTEN-C)

NCT03525262 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2026-06-05

No results posted yet for this 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

  • Prostate Cancer Adenocarcinoma

Interventions

RADIATION

30Gy (Gray) planning target volume (PTV)

PTV1\_30Gy represents a 3mm expansion on the prostate (and proximal seminal vesicle per physician discretion), excluding the neurovascular structures on the side to be spared (left or right). PTV1 will receive 6 Gy per fraction for 5 fractions (30 Gy).

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-24
Primary Completion
2027-04-30
Completion
2029-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03525262 on ClinicalTrials.gov