Clinical trial · Interventional
Vessel Sparing Prostate Radiation Therapy
Vessel Sparing Prostate Radiation Therapy: Dose Limitation to Critical Erectile Structures (Corpus Cavernosum and Internal Pudendal Artery) by MRI Based Treatment Planning
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prostate cancer patients have a number of excellent treatment options to consider, and quality of life following treatment is often a consideration in treatment choice. One critical quality of life concern for patients diagnosed with prostate cancer is sexual function. Previous studies point to a vascular mechanism of impotence post-radiation therapy, as opposed to a nerve-based mechanism following surgery. In this study, the critical vascular structures (internal pudendal artery and corpus cavernosum) are defined by MRI-based imaging and included in treatment planning for radiation treatments, hopefully preserving critical artery function. This study will collect erectile function preservation rates at 5-years post-vessel-sparing radiotherapy with or without aids using the patient reported using the simplified three-question erectile function scale.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the PROSTATE | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Vessel Sparing Radiation Therapy using MRI based treatment planning to limit dose to critical erectile structures
- interventionNames
- Radiation: Radiation Therapy
Primary outcomes (1)
- measure
- The Percentage of Patients Able to be Sexually Active With or Without the Use of Aids
- timeFrame
- 5 years from end of radiation treatment
- description
- The primary endpoint of the study was to accurately determine the preservation of erectile function post radiation therapy. Erectile preservation was defined as a score of 1 or 2 on the three-tier patient reported questionnaire equating to being able to be sexually active with or without aids. Scoring: 1. Sexually active without aids 2. Sexually active with aids 3. Not sexually active with or without aids
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of prostate cancer * Patients must have measurable erectile function. Patients with erectile function on Viagra and drugs of the same class are eligible. Patients who require 6 months of hormonal therapy or less are eligible, provided baseline erectile function is measured prior to or within 14 days of the start of hormonal therapy. * Baseline PSA (Prostate Specific Antigen), TNM stage (a classification of malignant tumors in cancer), and Gleason Score (A system of grading prostate cancer tissue based on how it looks under a microscope): Patients with low (PSA less than 10, T2a or less, Gleason 6 or less), intermediate, or high (Gleason 8-10, T3a, PSA over 20) risk disease are eligible for this protocol. Patients on finasteride or drugs of the same class are eligible. * Patients must be 18 years or older. No upper age restriction. * Patients treated with external beam radiotherapy alone or external beam therapy plus implant therapy are eligible. * Patients must have an ECOG (Eastern Cooperative Oncology Group system of grading patient status that attempts to quantify cancer patients' general well-being and activities of daily life) performance status \<2. * The patient must sign study specific informed consent approved by the IRB of U of M indicating they are aware of the investigational nature of the treatment. Exclusion Criteria: * Patients who are impotent or have an IIEF (International Index of Erectile Function) \<16. * Patients who are medically ineligible for radiation therapy due to other medical conditions. * Patients given hormonal therapy before baseline questionnaires filled out. * Patients who receive implant only therapy. * Patients unable to undergo MRI (Magnetic Resonance Imaging).
References
Publications (1)
- DERIVEDSpratt DE, Lee JY, Dess RT, Narayana V, Evans C, Liss A, Winfield R, Schipper MJ, Lawrence TS, McLaughlin PW. Vessel-sparing Radiotherapy for Localized Prostate Cancer to Preserve Erectile Function: A Single-arm Phase 2 Trial. Eur Urol. 2017 Oct;72(4):617-624. doi: 10.1016/j.eururo.2017.02.007. Epub 2017 Feb 21. PMID 28233591