REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients) (NCT07302451) | Clinical Trial Compass
RecruitingPhase 2
REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients)
Italy50 participantsStarted 2026-02-23
Plain-language summary
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 details of the radiation treatment (like the dose and how it's delivered) relate to treatment success, side effects, and long-term outcomes such as cancer control, survival, and financial impact? Participants will receive hormonal therapy (Relugolix) following by radiotherapy. They will complete questionnaires on sexual function, quality of life, and financial impact before, during and after treatment, and attend follow-up visits for health assessments. The study will measure how many patients recover erectile function within six months of stopping hormonal therapy, how long recovery takes, how treatment doses relate to outcomes, and assess cancer control, side effects, quality of life, and survival.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, and Gleason score 7(4+3); ISUP grade 3);
* Signed informed consent for REDI-CaP protocol;
* Signed consent for REDI-CaP data processing;
* Prostate volume ≤ 80 cc;
* No evidence of prostate capsule invasion (documented by multiparametric MRI of the prostate);
* Performance status: 0-1;
* Negative total-body CT with contrast and bone scan for metastases;
* Negative PSMA PET for secondary lesions;
* IIEF-5 score: ≥ 8;
* Patient compliance with completing periodic questionnaires and attending regular follow-ups as required by the study.
Exclusion Criteria:
* Have prostate cancer classified as low-risk, favorable intermediate-risk, or high-risk;
* Exhibit erectile dysfunction at baseline (IIEF-5 score: \< 8);
* Show positive PSMA PET results for metastases or pelvic lymph nodes;
* Have capsular involvement documented by multiparametric prostate MRI;
* Have contraindications to radiotherapy and/or hormone therapy;
* Are unable to undergo MRI;
* Cannot adhere to periodic tests and follow-ups;
* Refuse or have contraindications to the implantation of intraprostatic fiducials.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recovery of Erectile Function (IIEF-5) at 6 Months Post-ADT: ≥70% Threshold for Study Success
Timeframe: 6 months after completion of hormonal therapy (Relugolix)