BridgeMD
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
EU CTIS ID: 2025-521170-33-00
What this study is testing
To evaluate the recovery of erectile function at six months after hormonal therapy cessation compared to baseline.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age > 18 years
- IIEF-5 score: > 8
- Patient compliance with completing periodic questionnaires and attending regular follow-ups as required by the study.
- 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 consent for REDI-CaP data processing Version 1.0 dated 05.10.2024
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
- Age > 18 years
- IIEF-5 score: > 8
- Patient compliance with completing periodic questionnaires and attending regular follow-ups as required by the study.
- 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 consent for REDI-CaP data processing Version 1.0 dated 05.10.2024
- 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
- 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.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.