NCT07302451 REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients)
| NCT ID | NCT07302451 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | National Cancer Institute, Naples |
| Condition | Prostate Cancer (Adenocarcinoma) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-02-23 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2026-02-23 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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, 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07302451 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer (Adenocarcinoma). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07302451 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07302451 currently recruiting?
Yes, NCT07302451 is actively recruiting participants. Contact the research team at r.difranco@istitutotumori.na.it for enrollment information.
Where is the NCT07302451 trial being conducted?
This trial is being conducted at Naples, Italy.
Who is sponsoring the NCT07302451 clinical trial?
NCT07302451 is sponsored by National Cancer Institute, Naples. The trial plans to enroll 50 participants.
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