Relugolix and Radiotherapy for Prostate Cancer Recovery
REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients)
Recruiting
Phase 2
Interventional Study
Prostate Cancer (Adenocarcinoma)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- National Cancer Institute, Naples · Other
Who this trial is looking for
This trial is looking for men with advanced prostate cancer who are interested in finding out how well they recover sexual function after stopping hormone therapy. Participants will receive treatment and complete surveys about their health and quality of life during and after the study.
Are You a Good Fit for This Trial?
You may be able to join if
- I am male.
- I am over 18 years old.
- I have been diagnosed with prostate cancer.
- I have an unfavorable intermediate-risk classification.
- I have signed consent forms for the study.
- My prostate volume is 80 cc or less.
- I do not have evidence of prostate capsule invasion.
- I am able to complete questionnaires and attend follow-ups as needed.
You may not be able to join if
- I have prostate cancer classified as low-risk or high-risk.
- I have erectile dysfunction at the start of the trial.
- I have positive results for metastases from a PSMA PET scan.
- I have evidence of capsular involvement from an MRI.
- I have conditions that prevent me from receiving radiotherapy or hormone therapy.
- I cannot undergo an MRI.
- I cannot keep up with periodic tests and follow-ups.
- I refuse or cannot have intraprostatic fiducials implanted.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
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Answer a few quick questions to see if you may meet the eligibility requirements.
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About This Trial
The goal of this study is to evaluate the recovery of erectile function at six months after hormonal therapy cessation in male patients affected by advanced prostate cancer and undergoing radiotherapy. The main questions are:
* How well and how quickly do patients recover their sexual function and overall quality of life after stopping hormone therapy and receiving radiotherapy?
* How do the deta…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Male sex. (This criterion is required for the patient population being studied and for the correct data structuring in CTIS.)
* Age \> 18 years;
* Diagnosis of prostate cancer via transperineal core biopsy;
* Classified as unfavorable intermediate-risk (T2b-2c, PSA ≤ 20 ng/mL,…
Contacts