About this trial
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
Qualifiers
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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Combined Androgen Deprivation Therapy with Relugolix and Image-Guided Stereotactic Body Radiotherapy (SBRT)