CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
68Ga-PSMA-11 PET Scanother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04936334
NCT04936334Phase 2Completed
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The Role of 68Ga-PSMA-11 PET in Surgery Guidance in Prostate Cancer: A Prospective Pilot Trial

Clinton Bahler·interventional·Posted Jun 23, 2021·Updated Aug 3, 2023

In Brief

A Phase 2 clinical trial evaluating 68Ga-PSMA-11 PET Scan for Prostate Cancer. Completed, enrolled 51 participants across 1 site.

Detailed Summary

Obtain PSMA-PET imaging preoperatively and calculate performance for predicting extra-prostatic extension based on whole-mount pathology (gold standard). Quantify the frequency of proper treatment changes directed by PSMA-PET, focusing on appropriate preservation of surrounding structures important for genito-urinary function including: 1) Bladder neck, 2) Nerve bundles, 3) Urethral Sphincter (Figure 4). Directly compare PSMA-PET performance for predicting extra-prostatic extension to standard-of-care assessments. Assess quality of life changes from preoperative baseline.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJun 23, 2021
Enrollment StartJun 11, 2021
Primary CompletionJul 18, 2022
Study CompletionJul 19, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.0 years ago

Interventions

68Ga-PSMA-11 PET Scanother

Patients will undergo injection of 68Ga-PSMA-11 at the time of their pre treatment PSMA PET scan and followed until 12 months post surgery.