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Taking people in ItalyPhase 2

Relugolix and focused radiotherapy for prostate cancer, looking at erectile function recovery

Studies how erectile function recovers after relugolix and radiotherapy in men with prostate cancer.

Key facts

Who runs it
National Cancer Institute, Naples
Where
Naples, ItalySee the site
Registry title
REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients)
Status
Recruiting
Phase
Phase 2
People taking part
50 people, planned
Started
23 Feb 2026
Expected to end
23 Feb 2031
Type of study
Interventional
Treatments tested
  • Combined Androgen Deprivation Therapy with Relugolix and Image-Guided Stereotactic Body Radiotherapy (SBRT)
Record updated
21 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men with prostate cancer of unfavorable intermediate risk who have not had spread to other parts of the body. It looks at recovery of erectile function after hormone therapy and radiotherapy.

Age
Older than 18 years.
Sex
Men only.
Disease stage
Prostate cancer confirmed by biopsy, unfavorable intermediate risk (T2b-2c, PSA 20 ng/mL or lower, Gleason score 7(4+3), ISUP grade 3). Prostate volume 80 cc or less. No invasion of the prostate capsule on MRI. No spread to other parts of the body on CT, bone scan and PSMA PET. Performance status 0-1.
Biomarker or test result
Erectile function score (IIEF-5) of 8 or higher at the start.

Main reasons for not taking part

  • Low-risk, favorable intermediate-risk or high-risk prostate cancer
  • Erectile dysfunction at the start (IIEF-5 score below 8)
  • Metastases or pelvic lymph nodes positive on PSMA PET
  • Cannot have an MRI
  • Refuses or cannot have intraprostatic fiducials implanted

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Have contraindications to radiotherapy and/or hormone therapy
  • 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
  • Are unable to undergo MRI
  • Cannot adhere to periodic tests and follow-ups
  • Refuse or have contraindications to the implantation of intraprostatic fiducials

Where in Italy

  • IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, ItalyTaking people

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

* 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.

The group in the trial

  • Unfavorable Intermediate-Risk Prostate CancerTreatment being tested

    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).

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
REDI-CaP (Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients). Innovative Management of Patients With Unfavorable Intermediate-Risk Prostate Cancer: a Special Focus on Quality of Life and Erectile Function Recovery
Plain-language title
Relugolix and focused radiotherapy for prostate cancer, looking at erectile function recoveryGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Publications
Record updated
21 July 2026