NCT07302451RecruitingPhase 2
REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients)
REDI-CaP (Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients). Innovative Management of Patients With Unfavorable Intermediate-Risk Prostate Cancer: a Special Focus on Quality of Life and Erectile Function Recovery
Source: ClinicalTrials.gov · Last updated 21 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 11 Dec 2025
- Start date
- 23 Feb 2026
- Primary completion date
- 31 May 2027
- Lead sponsor
- National Cancer Institute, Naples
- Diseases
- Prostate cancer
- NCT number
- NCT07302451
- EU CT number
- 2025-521170-33-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 23 Feb 2026 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have contraindications to radiotherapy and/or hormone therapy;
Other illness
- Have prostate cancer classified as low-risk, favorable intermediate-risk, or high-risk;
Other
- 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;
- Are unable to undergo MRI;
- Cannot adhere to periodic tests and follow-ups;
- Refuse or have contraindications to the implantation of intraprostatic fiducials.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
Related publications
- Study protocol on quality of life and erectile function recovery in unfavorable intermediate-risk prostate cancer: REDI-CaP trial.Future Oncol · 2026 · PMID 42656189
This page is information, not medical advice. Discuss any trial with your doctor.