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

Sponsor
National Cancer Institute, Naples
Study ID
NCT07302451
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Prostate Cancer (Adenocarcinoma)

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Dec 1, 2025
Status verified
Dec 2025
Primary completion
May 31, 2027
Completion
Dec 31, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Unfavorable Intermediate-Risk Prostate Cancer
    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).

Primary Outcome Measure

Recovery of Erectile Function (IIEF-5) at 6 Months Post-ADT: ≥70% Threshold for Study Success [ Time Frame: 6 months after completion of hormonal therapy (Relugolix) ]

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