REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients)
Recruiting · NCT07302451 · Interventional (participants receive a specific treatment) · Lead sponsor: National Cancer Institute, Naples
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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.
Where it is running
1 location listed.
- Istituto Nazionale Tumori - IRCCS - Fondazione G. Pascale - Napoli - Naples, Italy