REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients)

NCT07302451 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: INT IRCCS Fondazione PascaleEUCT number: 2025-521170-33-00
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer (Adenocarcinoma)

Keywords

Erectile Function Recovery; Relugolix; Androgen Deprivation Therapy (ADT); Stereotactic Body Radiotherapy (SBRT); Cyberknife System; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months after completion of hormonal therapy (Relugolix)

Secondary Outcomes (1)

• Time to Sexual Function Recovery and Secondary Clinical Outcomes

  From end of hormonal therapy to 36 months post-treatment

Study Arms (1)

Unfavorable Intermediate-Risk Prostate Cancer

EXPERIMENTAL

This single arm study includes male patients over 18 years of age with histologically confirmed unfavorable intermediate-risk prostate cancer, defined as clinical stage T2b-T2c, PSA ≤ 20 ng/mL, Gleason score 7 (4+3), and ISUP grade 3. Participants must have a prostate volume \< 80 cc, preserved erectile function (IIEF-5 \> 8), ECOG performance status 0-1, and no evidence of capsular invasion or metastatic disease (based on multiparametric MRI, PSMA PET, CT with contrast, and bone scan).

Combination Product: Combined Androgen Deprivation Therapy with Relugolix and Image-Guided Stereotactic Body Radiotherapy (SBRT)

Interventions

Combined Androgen Deprivation Therapy with Relugolix and Image-Guided Stereotactic Body Radiotherapy (SBRT) COMBINATION_PRODUCT

Participants will receive oral androgen deprivation therapy (ADT) with Relugolix (120 mg daily for 12 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 5-12). 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 18-month follow-up.

Unfavorable Intermediate-Risk Prostate Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (1)

Istituto Nazionale Tumori - IRCCS - Fondazione G. Pascale - Napoli

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Interventions

relugolix

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Radiation Oncology

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)