Trial · NCT07302451
REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients)
NCT07302451, Phase 2, Recruiting, National Cancer Institute, Naples
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients). Trials, record NCT07302451. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07302451
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients)
- NCT number
- NCT07302451
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 50 participants, estimated
- Lead sponsor
- National Cancer Institute, Naples
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Interventions
- Combined Androgen Deprivation Therapy with Relugolix and Image-Guided Stereotactic Body Radiotherapy (SBRT)
- First posted
- 2025-12-24
- Last updated
- 2026-07-21
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recovery of Erectile Function (IIEF-5) at 6 Months Post-ADT: ≥70% Threshold for Study Success | 6 months after completion of hormonal therapy (Relugolix) | 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. |
| Secondary | Time to Sexual Function Recovery and Secondary Clinical Outcomes | From end of hormonal therapy to 36 months post-treatment | Time from cessation of hormonal therapy to recovery of sexual function, defined as achieving and maintaining an IIEF-5 score ≥8 for at least two consecutive assessments. This threshold reflects clinically meaningful erectile function based on literature and the study's primary endpoint. Recovery will be evaluated relative to baseline. Correlations will be explored between recovery and radiation dose to critical structures (penile bulb, crura, internal pudendal artery, neurovascular bundles, testes). Additional outcomes include bPFS (Phoenix criteria), local control, dPFS, OS, urinary/rectal toxicity (RTOG, IPSS), QoL (EORTC QLQ-C30, PR25, IIEF-5), and financial toxicity (PROFFIT). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42656189 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07302451
GET https://conductscience.org/api/trials/v1/NCT07302451/registered