PSMA-PET for Biopsy and Treatment Guidance in Primary Prostate Cancer

NCT ID: NCT03429244

Last Updated: 2023-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2022-05-01

Brief Summary

The overall objective of this Early Phase Clinical Trial is to begin defining the accuracy of 68Ga-PSMA-11 for detecting the location and size of clinically significant prostate cancer lesions in low and intermediate risk disease.

A molecularly-targeted probe (68Ga-PSMA-11), coupled with an advanced clinical imaging system (Siemens Biograph VisionPET-CT), will improve accuracy during biopsy and staging. We propose detailed intra-lesion whole-mount pathologic analysis as the gold standard for critically assessing PSMA PET accuracy in patients undergoing surgery, and blinded PSMA PET-CT comparison with standard multi-parametric MRI (mpMRI) for patients having biopsy on active surveillance. This intensive testing of the accuracy and value of PSMA-based tracers requires our unique collaboration of surgeons, radiologists, pathologists, and imaging scientists with decades of experience and innovation.

Detailed Description

This is a prospective, single arm, phase 2 clinical trial. This patient population will have low (1 = Gleason 3 + 3) or intermediate risk (2 = 3 + 4; 3 = 4 + 3) prostate cancer. It will also enroll those who are at high risk of significant prostate cancer (4Kscore >20%, SelectMDx >20%, PSA density >0.15). Patients will be scheduled for magnetic resonance imaging (MRI) as part of routine care for either surgical planning or for further biopsy. Following the informed consent process, patients who enroll in the study will receive a PSMA positron emission tomography (PET) study along with their standard of care (SOC) MRI on an integrated PET-MRI. Registration of PET and MRI will be done using software to generate the PET-MRI images. Patients receiving SOC MRI guided biopsy will receive additional PET guided biopsies as indicated in a single session. The sensitivity and specificity will be evaluated along with the ability of the tracer to inform the treatment planning. Patients receiving surgical removal of the prostate will have a slice-by-slice whole mount analysis to assess the sensitivity and specificity the PSMA PET.

Primary Objectives Define the accuracy of 68Ga-PSMA-11 PET-CT for detecting the clinically significant prostate cancer lesion.

Secondary Objectives Evaluate how knowledge of the PSMA-PET might inform treatment planning.

Exploratory Objectives Generate pilot data for future larger clinical trials

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Prostate cancer- men being treated with radical prostatectomy

Men being treated for prostate cancer with radical prostatectromy were enrolled in this arm.

Group Type: EXPERIMENTAL

68Ga-PSMA-11 PET-MRI

Intervention Type: DIAGNOSTIC_TEST

Patients will undergo injection of 68Ga-PSMA-11 at the time of pre-treatment MRI scan and followed until biopsy and/or surgical resection.

Prostate cancer- men undergoing cancer screening or active surveillance

Men undergoing cancer screening or active surveillance were enrolled in this arm.

Group Type: EXPERIMENTAL

68Ga-PSMA-11 PET-MRI

Intervention Type: DIAGNOSTIC_TEST

Patients will undergo injection of 68Ga-PSMA-11 at the time of pre-treatment MRI scan and followed until biopsy and/or surgical resection.

Prostate cancer- focal therapy

Men undergoing focal therapy with high intensity focused ultrasound are in this group.

Group Type: EXPERIMENTAL

68Ga-PSMA-11 PET-MRI

Intervention Type: DIAGNOSTIC_TEST

Patients will undergo injection of 68Ga-PSMA-11 at the time of pre-treatment MRI scan and followed until biopsy and/or surgical resection.

Interventions

68Ga-PSMA-11 PET-MRI

Patients will undergo injection of 68Ga-PSMA-11 at the time of pre-treatment MRI scan and followed until biopsy and/or surgical resection.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. ≥ 18 years of age

2. Must provide written informed consent

3. Presence of low or intermediate risk prostate cancer or at risk of having intermediate risk cancer

a. Intermediate risk prostate cancer: i. Grade group 2 = 3 + 4, or ii. Grade group 3 = 4 + 3 b. At Risk of intermediate risk prostate cancer: i. 4K score ≥ 20%, or ii. Select MDx ≥ 20%, or iii. PSA Density ≥ 0.15 iv. Grade group 1= 3+3 (iv. Note: Where multiple cancer lesions are present on biopsy, it is allowable to have Gleason 8 or 9 cancer lesions if they are in addition to the intermediate risk cancer as described above.)

4. Scheduled for MRI or has recently completed SOC MRI (within 6 months) for further biopsy, or surgical removal, or focal therapy.

5. Willing and able to lie still for approximately 50 minutes in an enclosed space for the CT.

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 is not allowed).

3. Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Clinton Bahler

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Clinton Bahler, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Indiana University Health North Hospital

Carmel, Indiana, United States

Indiana University Health Hospital

Indianapolis, Indiana, United States

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Countries

United States

References

Bahler CD, Green MA, Tann MA, Swensson JK, Collins K, Alexoff D, Kung H, Brocken E, Mathias CJ, Cheng L, Hutchins GD, Koch MO. Assessing extra-prostatic extension for surgical guidance in prostate cancer: Comparing two PSMA-PET tracers with the standard-of-care. Urol Oncol. 2023 Jan;41(1):48.e1-48.e9. doi: 10.1016/j.urolonc.2022.10.003. Epub 2022 Nov 1.

Reference Type: RESULT

PMID: 36333187 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1802085219

Identifier Type: OTHER

Identifier Source: secondary_id

IUSCC-0658

Identifier Type: -

Identifier Source: org_study_id