Erectile Function PRESERVation in Definitive Radiotherapy for Prostate Cancer by MRI-Enhanced Adaptive Sparing of the Neurovascular Bundle
NCT07916779, Not applicable, Not yet recruiting, University of Zurich
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Erectile Function PRESERVation in Definitive Radiotherapy for Prostate Cancer by MRI-Enhanced Adaptive Sparing of the Neurovascular Bundle | ClinicalTrials.gov |
| NCT number | NCT07916779 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 48 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Zurich | ClinicalTrials.gov |
| Conditions | Prostate Cancer, Localized Prostate Carcinoma, Low-Risk Prostate Cancer, Intermediate-risk Prostate Cancer, Radiation-Induced Erectile Dysfunction, Erectile Dysfunction Following Radiation Therapy | ClinicalTrials.gov |
| Interventions | Daily Adaptive MR-Enhanced SBRT with Neurovascular Bundle Sparing | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proportion of Patients with CTCAE v6.0 Grade ≥2 Erectile Dysfunction at 1 Year Post-SBRT | 1 year post-SBRT | Evaluates the proportion of sexually active patients who develop clinician-reported moderate to severe erectile dysfunction (defined as CTCAE v6.0 Grade ≥2) 1 year following the completion of adaptive MR-enhanced prostate SBRT with neurovascular bundle (NVB) sparing. The rate will be evaluated against historical controls from the PACE-B trial benchmark. | ClinicalTrials.gov |
| Secondary | Patient-Reported Erectile Function Change via IIEF-5 Score | Baseline, every 3 months for the first 1 year, and annually thereafter up to 5 years post-SBRT | Evaluates changes in patient-reported erectile function using the 5-item International Index of Erectile Function (IIEF-5) questionnaire. Scores range from 5 to 25, with lower scores indicating more severe erectile dysfunction (ED). The mean score change from baseline, the proportion of patients maintaining potency, and the proportion experiencing a clinically meaningful decline (≥4 point drop in IIEF-5 score) will be evaluated across time points. | ClinicalTrials.gov |
| Secondary | Biochemical progression-free survival | Baseline, every 3 months for the first 1 year, and annually thereafter up to 5 years post-SBRT | Measurement of PSA, biochemical progression is defined according to phoenix criteria. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 9
The papers the trial lists on ClinicalTrials.gov.
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)