🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients)

RecruitingPhase 2Ages 18 Years - anyMaleNational Cancer Institute, Naples
NCT07302451 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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 recov

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
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.
💊

What it tests

  • Combined Androgen Deprivation Therapy with Relugolix and Image-Guided Stereotactic Body Radiotherapy (SBRT)
📍

Where

1 site
Istituto Nazionale Tumori - IRCCS - Fondazione G. Pascale - Napoli
Naples, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy