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Study on Erectile Dysfunction Recovery in Prostate Cancer Patients Using Relugolix

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The REDI-CaP study focuses on unfavorable intermediate-risk prostate cancer patients who will undergo hormonal therapy. Prostate cancer occurs when abnormal cells grow uncontrollably in the prostate gland, a small walnut-shaped gland in men that produces seminal fluid. The unfavorable intermediate-risk classification refers to specific characteristics of the cancer, including tumor size and aggressiveness.

The purpose of this study is to evaluate the recovery of erectile function (the ability to achieve and maintain an erection) six months after completing hormonal therapy. Hormonal therapy for prostate cancer works by reducing male hormones (androgens) that can stimulate cancer growth, but may cause side effects including erectile dysfunction (difficulty achieving or maintaining an erection).

During the study, participants will receive treatment and then be monitored through regular follow-up visits and questionnaires that assess erectile function, urinary and rectal symptoms, and overall quality of life. The study will also examine factors that might influence erectile function recovery, such as radiation doses to specific anatomical structures like the penile bulb, neurovascular bundles (nerves and blood vessels around the prostate that control erections), and other surrounding tissues.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial Evaluation and Baseline Assessment
At the beginning of the trial, your erectile function will be assessed using the International Index of Erectile Function-5 (IIEF-5) questionnaire. This is a standardized tool that measures erectile function on a numerical scale.
You will also complete several quality of life questionnaires including EORTC QLQ-C30 (general cancer quality of life), PR25 (prostate cancer-specific quality of life), and PROFFIT (financial impact of treatment).
Step 2
Hormonal Therapy with Relugolix
You will receive Orgovyx (relugolix) in the form of 120 mg film-coated tablets. This medication helps to reduce testosterone levels, which can slow the growth of prostate cancer cells.
You will need to take this medication exactly as prescribed. The study will monitor how this hormonal therapy affects your erectile function and overall quality of life.
Step 3
Radiation Treatment Planning
Before radiation therapy begins, detailed imaging of your prostate and surrounding areas will be performed to create a precise treatment plan.
The radiation dose to sensitive structures including the penile bulb, crura, internal pudendal artery, periprostatic neurovascular bundles, and testes will be carefully measured, as these structures are related to erectile function.
Step 4
Radiation Therapy
You will undergo radiation therapy for your prostate cancer according to the treatment plan.
During this period, your side effects will be monitored using standardized scales including the RTOG (Radiation Therapy Oncology Group) scale for radiation side effects and the IPSS (International Prostate Symptom Score) for urinary symptoms.
Step 5
Regular Follow-up Assessments
You will have regular follow-up appointments to monitor your response to treatment, side effects, and overall health.
At these visits, your PSA (Prostate Specific Antigen) levels will be checked to monitor for cancer recurrence.
You will complete questionnaires about your urinary function, bowel function, sexual function, and overall quality of life at scheduled intervals.
Step 6
Cessation of Hormonal Therapy
After completing the prescribed course of hormonal therapy, you will stop taking relugolix as directed by your doctor.
The study will then monitor how quickly your hormonal levels return to normal and how this affects your erectile function.
Step 7
Six-Month Post-Hormonal Therapy Assessment
Six months after stopping hormonal therapy, you will have a comprehensive assessment of your erectile function using the IIEF-5 questionnaire.
This is the primary measurement the study is interested in - how well erectile function recovers after hormonal therapy compared to your baseline function before treatment.
You will also complete additional quality of life questionnaires to assess your overall wellbeing at this point.
Step 8
Long-term Follow-up
You will continue to be monitored for bPFS (biochemical progression-free survival), which measures if your PSA remains at acceptable levels.
The study will track local control (absence of cancer recurrence in the prostate area) and dPFS (distant progression-free survival, or absence of cancer spread to other parts of the body).
Your overall survival and any late side effects from treatment will be monitored until the study concludes in September 2030.

Who can join the trial?

13 criteria

You must be over 18 years old
You must have an IIEF-5 score greater than 8 (this is a questionnaire that measures erectile function)
You must be willing to complete questionnaires and attend regular follow-up appointments as required by the study
You must have a prostate cancer diagnosis confirmed by transperineal core biopsy (a procedure where tissue samples are taken from the prostate through the area between the scrotum and rectum)
Your prostate cancer must be classified as unfavorable intermediate-risk, meaning:
- Tumor stage T2b-2c (cancer confined to the prostate but affecting more than half of one side or both sides)
- PSA level of 20 ng/mL or less (PSA is a protein produced by the prostate that can be measured in blood)
- Gleason score 7(4+3) or ISUP grade 3 (these are systems to grade how aggressive the cancer appears)
- You must have signed consent for REDI-CaP data processing
- Your prostate volume must be less than 80 cc (cubic centimeters)
- You must have no evidence of cancer spreading beyond the prostate capsule (as shown on multiparametric MRI)
- You must have a performance status of 0-1 (meaning you're either fully active or restricted in physically strenuous activity but able to carry out light work)
- You must have negative results on total-body CT scan with contrast and bone scan (showing no spread of cancer to other parts of the body)
- You must have a negative PSMA PET scan (a specialized imaging test that looks for prostate cancer cells throughout the body)

Who cannot join the trial?

12 criteria

Patients with any other cancer besides prostate cancer
Patients who have had previous surgery on the prostate
Patients who have had previous radiation therapy to the pelvic area
Men who have significant heart or blood vessel disease
Men with erectile dysfunction (inability to get or maintain an erection) before starting hormonal therapy
Patients with severe liver or kidney problems
Men taking medications that affect sexual function
Patients with uncontrolled diabetes (a condition where blood sugar levels are too high)
Patients who are unable to provide informed consent
Men with severe psychiatric conditions that would interfere with study participation
Patients allergic to any of the study medications
Men currently participating in other clinical trials

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Verified sites

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IRCCS Istituto Nazionale Tumori Fondazione Pascale
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Naples, Italy

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Investigated drugs

The medications or therapies involved in this clinical trial are: Hormonal therapy is a treatment that affects male hormones (testosterone) in the body. For prostate cancer patients, hormonal therapy works by reducing testosterone levels or blocking its effects, which can slow down the growth of prostate cancer cells. This treatment is commonly used for various stages of prostate cancer.

Relugolix

What is already known about the treatment

Hormonal therapy – A treatment approach for prostate cancer that works by lowering testosterone levels or blocking testosterone effects on cancer cells. Hormonal therapy (also called androgen deprivation therapy) is commonly used in intermediate-risk prostate cancer patients, either alone or in combination with radiation therapy, to slow cancer growth by depriving cancer cells of hormones they need to grow. The medication works at the molecular level by either reducing testosterone production or preventing testosterone from binding to receptors on cancer cells. While effective against cancer, hormonal therapy may cause side effects including erectile dysfunction, which is often temporary and may improve after treatment ends, making erectile function recovery an important focus in prostate cancer care.

Investigated diseases

Prostate Cancer - A disease characterized by abnormal cell growth in the prostate gland, which is part of the male reproductive system. Prostate cancer typically develops slowly and initially remains confined to the prostate gland, where it may not cause serious harm. As the cancer progresses, malignant cells can grow through the prostate and into surrounding tissues. In advanced stages, cancer cells may travel through the bloodstream or lymphatic system to other parts of the body, particularly the bones and lymph nodes. The disease is often asymptomatic in early stages, but later may cause urinary problems, blood in semen, erectile dysfunction, pain in the lower back or pelvis, and weakness or numbness in the legs or feet.