Clinical trial · Interventional
The Role of 68Ga-PSMA-11 PET (Prostate Specific Membrane Antigen) in Surgery Guidance in Prostate Cancer
The Role of 68Ga-PSMA-11 PET in Surgery Guidance in Prostate Cancer: A Prospective Pilot Trial
- 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)
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.
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 | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-PSMA-11 PET Scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Men diagnosed with clinically significant prostate cancer who are scheduled for prostatectomy
- description
- 1\. Men diagnosed with clinically significant prostate cancer who are scheduled or for prostatectomy will undergo injection of 68Ga-PSMA-11 at the time of their pre-treatment PSMA PET. Followed until 12 mo post surgery
- interventionNames
- Diagnostic Test: 68Ga-PSMA-11 PET Scan
Primary outcomes (2)
- measure
- Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension
- timeFrame
- The patients underwent a 60minute PET exam. The surgery was generally performed within 1month of the PET scan. The pathology was done 5-10 days after the surgery.
- description
- Sensitivity detecting extra-prostatic extension of cancer at the nerve bundles
- measure
- Specificity of PSMA-PET and MRI
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Men diagnosed with clinically significant prostate cancer who are scheduled or scheduling for prostatectomy 2. Prostate pathology results consistent with: 1. \> 3 cores of Gleason 3+4 or 2. NCCN unfavorable intermediate risk or 3. NCCN high-risk or 4. NCCN very-high risk 3. Scheduled for standard of care MRI or has recently completed standard of care MRI (within 6 months). Willing and able to lie still for approximately 50 minutes in an enclosed space for the PET/CT and MRI Exclusion Criteria: * 1\. Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days. 2\. Does not meet safety criteria for MRI scan (e.g. metal implant that could affect prostate imaging). 3\. Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.
References
Publications (1)
- DERIVEDBahler CD, Tachibana I, Tann M, Collins K, Swensson JK, Green MA, Mathias CJ, Tong Y, Yong C, Boris RS, Brocken E, Hutchins GD, Sims JB, Hill DV, Smith N, Ferari C, Love H, Koch MO. Comparing Magnetic Resonance Imaging and Prostate-Specific Membrane Antigen-Positron Emission Tomography for Prediction of Extraprostatic Extension of Prostate Cancer and Surgical Guidance: A Prospective Nonrandomized Clinical Trial. J Urol. 2024 Aug;212(2):290-298. doi: 10.1097/JU.0000000000004032. Epub 2024 May 24. PMID 38785259