BridgeMD
New treatment option 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)?
Combined Androgen Deprivation Therapy with Relugolix and Image-Guided Stereotactic Body Radiotherapy (SBRT) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for prostate cancer (adenocarcinoma).
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 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?
- 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's taking place
- 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 - 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?
Study sites include Naples, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.