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

NCT03429244 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IUSCC-06581802085219
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of PSMA PET

  Sensitivity and specificity for EPE using whole-mount analysis or biopsy pathology. EPE is extra-prostatic extension which means the cancer extends beyond the boundary of the prostate into adjacent muscle or fatty tissue.

  60 days

Secondary Outcomes (1)

• Impact of PSMA PET-CT on Treatment Plan for Surgery or Biopsy

  60 days

Study Arms (3)

Prostate cancer- men being treated with radical prostatectomy

EXPERIMENTAL

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

Diagnostic Test: 68Ga-PSMA-11 PET-MRI

Prostate cancer- men undergoing cancer screening or active surveillance

EXPERIMENTAL

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

Diagnostic Test: 68Ga-PSMA-11 PET-MRI

Prostate cancer- focal therapy

EXPERIMENTAL

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

Diagnostic Test: 68Ga-PSMA-11 PET-MRI

Interventions

68Ga-PSMA-11 PET-MRI 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; Prostate cancer- men being treated with radical prostatectomy; Prostate cancer- men undergoing cancer screening or active surveillance

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This is a prostate cancer study which can only be done with males.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age
• Must provide written informed consent
• 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.)
• Scheduled for MRI or has recently completed SOC MRI (within 6 months) for further biopsy, or surgical removal, or focal therapy.
• Willing and able to lie still for approximately 50 minutes in an enclosed space for the CT.

You may not qualify if:

• Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
• Does not meet safety criteria for MRI scan (e.g. metal implant that is not allowed).
• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (4)

Indiana University Health North Hospital

Carmel, Indiana, 46032, United States

Location

Indiana University Health Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• 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.

  PMID: 36333187 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Jennifer Lehman
• Organization: Indianan University School of Medicine

jgeck@iu.edu

3179489575

Study Officials

• Clinton Bahler, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Two separate Radiologists (one from Nuclear Medicine and one from MRI) will do the imaging reads in a blinded fashion.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: 68Ga-PSMA-11 PET will be performed and we will study how the knowledge of the results helps inform treatment decisions.

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 12, 2018
• Study Start: April 15, 2019
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: May 8, 2023
• Results First Posted: May 8, 2023

Record last verified: 2023-04

Locations

US (4)