Clinical trial · Interventional
REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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? * 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer (Adenocarcinoma) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined Androgen Deprivation Therapy with Relugolix and Image-Guided Stereotactic Body Radiotherapy (SBRT) | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Unfavorable Intermediate-Risk Prostate Cancer
- description
- 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).
- interventionNames
- Combination Product: Combined Androgen Deprivation Therapy with Relugolix and Image-Guided Stereotactic Body Radiotherapy (SBRT)
Primary outcomes (1)
- measure
- Recovery of Erectile Function (IIEF-5) at 6 Months Post-ADT: ≥70% Threshold for Study Success
- timeFrame
- 6 months after completion of hormonal therapy (Relugolix)
- description
- Assessment of erectile function recovery 6 months after cessation of hormonal therapy (Relugolix), using the International Index of Erectile Function-5 (IIEF-5). Recovery is defined as either (1) an IIEF-5 score ≥17 (indicating mild or no erectile dysfunction) and/or (2) an increase of ≥5 points from baseline. Only patients with baseline IIEF-5 \<22 (i.e., some degree of erectile dysfunction) will be included in the analysis. The study will be considered successful if ≥70% of the eligible population meets the recovery criteria at the 6-month evaluation following ADT completion.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion 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. Exclusion Criteria: * 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.
References
Publications (1)
- DERIVEDDi Franco R, Mercogliano S, Mottareale R, Borzillo V, Scipilliti E, Serra M, Buonanno F, Ametrano G, Perrone F, Piccirillo MC, Pignata S, Rossetti S, Perdona S, Franzese D, Izzo A, Muscariello R, Grimaldi G, Castaldo L, Lastoria S, Di Gennaro F, Raddi M, Petrillo A, Simonetti I, Cavalcanti E, De Falco R, di Franco MA, Maiolino P, Pagliuca MI, Roberta D, Vincenzo R. Study protocol on quality of life and erectile function recovery in unfavorable intermediate-risk prostate cancer: REDI-CaP trial. Future Oncol. 2026 Aug 27:1-8. doi: 10.1080/14796694.2026.2723713. Online ahead of print. PMID 42656189