Relugolix with SBRT for erectile function recovery after prostate cancer therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial assigns men to receive Relugolix as androgen deprivation therapy followed by image-guided SBRT. It measures erectile function recovery at six months after stopping hormonal therapy, using the IIEF-5 score with predefined recovery criteria. Participants complete questionnaires on sexual function, quality of life, and financial impact throughout treatment and during follow-up. The study also analyzes how radiation dose and delivery influence cancer control, side effects, and long-term outcomes. Enrollment targets men with unfavorable intermediate-risk prostate cancer who meet specific clinical criteria.

Why it matters

Who can join: the full rules

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's running

• Istituto Nazionale Tumori - IRCCS - Fondazione G. Pascale - Napoli
  Naples, Italy Recruiting

Study contacts

• Study coordinator: Rossella Di Franco, Radiation Oncologist
• Email: r.difranco@istitutotumori.na.it
• Phone: +39 08117770569

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.