RELUGOLIX for Prostate cancer

Inclusion criteria

• {"criterion_text":"- Age > 18 years\n- IIEF-5 score: > 8\n- Patient compliance with completing periodic questionnaires and attending regular follow-ups as required by the study.\n- Diagnosis of prostate cancer via transperineal core biopsy\n- Classified as unfavorable intermediate-risk (T2b-2c, PSA ≤ 20 ng/mL, and Gleason score 7(4+3); ISUP grade 3)\n- Signed consent for REDI-CaP data processing Version 1.0 dated 05.10.2024\n- Prostate volume < 80 cc\n- No evidence of prostate capsule invasion (documented by multiparametric MRI of the prostate)\n- Performance status: 0-1\n- Negative total-body CT with contrast and bone scan for metastases\n- Negative PSMA PET for secondary lesions"}

Exclusion criteria

• {"criterion_text":"- Have prostate cancer classified as low-risk, favorable intermediate-risk, or high-risk\n- Exhibit erectile dysfunction at baseline (IIEF-5 score: < 8)\n- Show positive PSMA PET results for metastases or pelvic lymph nodes\n- Have capsular involvement documented by multiparametric prostate MRI\n- Have contraindications to radiotherapy and/or hormone therapy\n- Are unable to undergo MRI\n- Cannot adhere to periodic tests and follow-ups\n- Refuse or have contraindications to the implantation of intraprostatic fiducials"}

Primary endpoints

• {"endpoint_text":"- Assessment of the International Index of Erectile Function-5 (IIEF-5) score at six months after hormonal therapy cessation, indicating recovery in at least 70% of the study population.","definition_or_measurement_approach":"IIEF-5 questionnaire score assessed at six months after hormonal therapy cessation; primary outcome defined as recovery in at least 70% of the study population."}

Secondary endpoints

• {"endpoint_text":"- Time from hormonal therapy cessation to sexual function recovery relative to pre-treatment levels (SFRT)","definition_or_measurement_approach":"Time-to-event measure from hormonal therapy cessation to recovery of sexual function compared to pre-treatment baseline (SFRT)."}
• {"endpoint_text":"- Correlation of erectile function recovery with dose to the penile bulb, crura, internal pudendal artery, periprostatic neurovascular bundles, and testes","definition_or_measurement_approach":"Correlation analysis between dosimetric parameters (dose to specified structures) and erectile function recovery (IIEF-5)."}
• {"endpoint_text":"- bPFS per Phoenix criteria (nadir + 2 ng/mL)","definition_or_measurement_approach":"Biochemical progression-free survival defined by Phoenix criteria (PSA nadir + 2 ng/mL)."}
• {"endpoint_text":"- Local control, defined as time from treatment to local recurrence or last follow-up","definition_or_measurement_approach":"Time from treatment to local recurrence (or censored at last follow-up)."}
• {"endpoint_text":"- dPFS, defined as time from treatment to distant metastases or last follow-up","definition_or_measurement_approach":"Time from treatment to occurrence of distant metastases (or censored at last follow-up)."}
• {"endpoint_text":"- Acute and late urinary and rectal toxicity, measured using RTOG and IPSS scales","definition_or_measurement_approach":"Toxicity assessed using RTOG criteria and IPSS scale for urinary/rectal adverse events (acute and late)."}
• {"endpoint_text":"- QoL scores from questionnaires (EORTC QLQ-C30, PR25, IIEF-5)","definition_or_measurement_approach":"Quality of life measured using EORTC QLQ-C30, PR25 modules and IIEF-5 instrument at scheduled timepoints."}
• {"endpoint_text":"- Financial toxicity assessment (PROFFIT questionnaire)","definition_or_measurement_approach":"Financial toxicity assessed using the PROFFIT questionnaire."}
• {"endpoint_text":"- OS, defined as time from treatment to death or last follow-up","definition_or_measurement_approach":"Overall survival measured as time from treatment to death from any cause or censored at last follow-up."}

Italy

Earliest CTIS Part Ii Submission Date

10-06-2025

Latest Decision Or Authorization Date

13-05-2026

Processing Time Days

337

Number Of Sites

1

Number Of Participants

50

Primary sponsor

Full Name

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy