Erectile Dysfunction (ED) Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Istituto Nazionale Tumori - IRCCS - Fondazione G. Pascale - Napoli
RECRUITING
Naples
Contact Information
Primary
Rossella Di Franco, Radiation Oncologist
r.difranco@istitutotumori.na.it
+39 08117770569
Time Frame
Start Date: 2026-02-23
Estimated Completion Date: 2031-02-23
Participants
Target number of participants: 50
Treatments
Experimental: Unfavorable Intermediate-Risk Prostate Cancer
This single arm study includes male patients over 18 years of age with histologically confirmed unfavorable intermediate-risk prostate cancer, defined as clinical stage T2b-T2c, PSA ≤ 20 ng/mL, Gleason score 7 (4+3), and ISUP grade 3. Participants must have a prostate volume \< 80 cc, preserved erectile function (IIEF-5 \> 8), ECOG performance status 0-1, and no evidence of capsular invasion or metastatic disease (based on multiparametric MRI, PSMA PET, CT with contrast, and bone scan).
Sponsors
Leads: National Cancer Institute, Naples

This content was sourced from clinicaltrials.gov