Clinical trial for Prostate Cancer (Adenocarcinoma)
Official title REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients)
ClinicalTrials.gov ID: NCT07302451
What this study is testing
What is Combined Androgen Deprivation Therapy with Relugolix and Image-Guided Stereotactic Body Radiotherapy (SBRT)?
An investigational combination of oral hormone therapy and targeted radiation being studied for advanced prostate cancer. Relugolix is designed to lower testosterone levels by blocking the luteinizing hormone-releasing hormone receptor.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see how quickly and how well patients regain sexual function and quality of life after stopping hormone treatment and getting radiotherapy, and how the radiation dose affects outcomes.
- Who it's for
- Men with advanced prostate cancer who have been on hormone therapy and are about to receive radiotherapy.
- What's involved
- Participants will take the hormone drug Relugolix, then receive radiotherapy. They will fill out questionnaires on sexual function, quality of life, and finances before, during, and after treatment, and attend follow‑up visits for health checks.
- Time commitment
- The study lasts about six months after stopping hormone therapy, with regular visits and questionnaires during that period.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join 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;
You likely can't join 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;
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Naples, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Naples, Italy. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.