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

NCT07302451 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-06

No results posted yet for this study

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)

Interventions

COMBINATION_PRODUCT

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

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.

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2027-05-31
Completion
2030-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07302451 on ClinicalTrials.gov