Phase 2
N=135
Vessel Sparing Prostate Radiation Therapy
Cancer of the PROSTATE
Bottom Line
View on ClinicalTrials.gov: NCT02958787 ↗Enrolled (actual)
135
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: The Percentage of Patients Able to be Sexually Active With or Without the Use of Aids — 88 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Radiation Therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Michigan Rogel Cancer Center
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Patients Able to be Sexually Active With or Without the Use of Aids |
88 | — |
Summary
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT02958787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.