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.
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);
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;
Single group
Combined Androgen Deprivation Therapy with Relugolix and Image-Guided Stereotactic Body Radiotherapy (SBRT)
Combination productParticipants will receive oral androgen deprivation therapy (ADT) with Relugolix (120 mg daily for 6 months) and stereotactic body radiotherapy (SBRT) via CyberKnife®. ADT includes a neoadjuvant phase (months 1-3), concurrent SBRT phase (month 4), and adjuvant phase (months 5-6). About 7-10 days before SBRT, 3-4 intraprostatic fiducial markers will be implanted. SBRT consists of 5 fractions of 7.25 Gy (total 36.25 Gy) delivered over two weeks. Planning involves contrast-enhanced CT, with defined CTV and PTV, and sparing of organs at risk. Treatment uses real-time image guidance and motion tracking. The regimen aims to optimize tumor control while minimizing toxicity. Patients are monitored using RTOG criteria, quality of life questionnaires, PSA/testosterone levels, and financial toxicity assessments over an 12-month follow-up.
Recovery of Erectile Function (IIEF-5) at 6 Months Post-ADT: ≥70% Threshold for Study Success
Assessment of erectile function recovery 6 months after cessation of hormonal therapy (Relugolix), using the International Index of Erectile Function-5 (IIEF-5). Recovery is defined as either (1) an IIEF-5 score ≥17 (indicating mild or no erectile dysfunction) and/or (2) an increase of ≥5 points from baseline. Only patients with baseline IIEF-5 \<22 (i.e., some degree of erectile dysfunction) will be included in the analysis. The study will be considered successful if ≥70% of the eligible population meets the recovery criteria at the 6-month evaluation following ADT completion.
Time to Sexual Function Recovery and Secondary Clinical Outcomes
Time from cessation of hormonal therapy to recovery of sexual function, defined as achieving and maintaining an IIEF-5 score ≥8 for at least two consecutive assessments. This threshold reflects clinically meaningful erectile function based on literature and the study's primary endpoint. Recovery will be evaluated relative to baseline. Correlations will be explored between recovery and radiation dose to critical structures (penile bulb, crura, internal pudendal artery, neurovascular bundles, testes). Additional outcomes include bPFS (Phoenix criteria), local control, dPFS, OS, urinary/rectal toxicity (RTOG, IPSS), QoL (EORTC QLQ-C30, PR25, IIEF-5), and financial toxicity (PROFFIT).
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