Gallium-68 PSMA-11 PET in Intermediate to High-risk Preprostatectomy Patients

NCT02919111 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 16559NCI-2018-00038
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with high risk disease prior to prostatectomy.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (4)

• Sensitivity of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy

  Sensitivity is defined as the ratio of the proportion of the patients who have the condition of interest and whose test results are positive over the number who have the disease. Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true-negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Follow-up scans for up to one year can be used in analysis

  Up to 1 year

• Specificity of of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy

  Specificity is defined as the number of non-diseased participants correctly classified divided by all non-diseased individuals. Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true-negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Follow-up scans for up to one year can be used in analysis

  Up to 1 year

• Positive Predictive Value (PPV) of of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy

  PPV is the proportion of patients with positive test who actually have the disease. Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true-negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Follow-up scans for up to one year can be used in analysis

  Up to 1 year

• Negative Predictive Value (NPV) of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy

  NPV is the ratio of participants truly diagnosed as negative to all those who had negative test results. Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Follow-up scans for obtained up to one year after study scan be used in analysis.

  Up to 1 year

Secondary Outcomes (13)

• Number of Participants With Grade 3 Treatment-related Adverse Events

  Up to 3 days

• Sensitivity of PSMA PET for the Detection of Extra-pelvic Nodal Metastases

  Up to 1 year

• Specificity of PSMA PET for the Detection of Extra-pelvic Nodal Metastases

  Up to 1 year

• Positive Predictive Value of PSMA PET for the Detection of Extra-pelvic Nodal Metastases

  Up to 1 year

• Negative Predictive Value of PSMA PET for the Detection of Extra-pelvic Nodal Metastases

  Up to 1 year

Study Arms (1)

Ga-68 labeled PSMA-11 PET

EXPERIMENTAL

PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.

Drug: Ga-68 labeled PSMA-11 PET

Interventions

Ga-68 labeled PSMA-11 PET DRUG

Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.

Also known as: Ga-68 labeled DKFZ-PSMA-11, Ga-68 labeled Glu-NH-CO-NH- Lys(Ahx)-HBED-CC, Ga-68 labeled Glu-urea- Lys(Ahx)-HBED-CC, Ga-68 labeled HBED-CC PSMA

Ga-68 labeled PSMA-11 PET

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven prostate adenocarcinoma.
• Planned prostatectomy with lymph node dissection.
• Intermediate to high-risk disease (as determined by elevated Prostate-specific antigen (PSA) \[PSA\>10\], T-stage \[T2b or greater\], Gleason score \[Gleason score \> 6\] or other risk factors).
• Diagnostic CT or MRI as part of the PET study or performed within one month of PSMA PET.
• Karnofsky performance status of greater than 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent).
• Age \> 18.
• Ability to understand a written informed consent document, and the willingness to sign it.

You may not qualify if:

• Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam.
• Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy.
• Including focal ablation techniques (HiFu).
• Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and surgery.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94107, United States

Location

Related Publications (2)

• Djaileb L, Armstrong WR, Thompson D, Gafita A, Farolfi A, Rajagopal A, Grogan TR, Nguyen K, Benz MR, Hotta M, Barbato F, Ceci F, Schwarzenbock SM, Unterrainer M, Zacho HD, Juarez R, Cooperberg M, Carroll P, Washington S, Reiter RE, Eiber M, Herrmann K, Fendler WP, Czernin J, Hope TA, Calais J. Presurgical 68Ga-PSMA-11 Positron Emission Tomography for Biochemical Recurrence Risk Assessment: A Follow-up Analysis of a Multicenter Prospective Phase 3 Imaging Trial. Eur Urol. 2023 Dec;84(6):588-596. doi: 10.1016/j.eururo.2023.06.022. Epub 2023 Jul 21.

  PMID: 37482512 DERIVED

• Hope TA, Eiber M, Armstrong WR, Juarez R, Murthy V, Lawhn-Heath C, Behr SC, Zhang L, Barbato F, Ceci F, Farolfi A, Schwarzenbock SM, Unterrainer M, Zacho HD, Nguyen HG, Cooperberg MR, Carroll PR, Reiter RE, Holden S, Herrmann K, Zhu S, Fendler WP, Czernin J, Calais J. Diagnostic Accuracy of 68Ga-PSMA-11 PET for Pelvic Nodal Metastasis Detection Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection: A Multicenter Prospective Phase 3 Imaging Trial. JAMA Oncol. 2021 Nov 1;7(11):1635-1642. doi: 10.1001/jamaoncol.2021.3771.

  PMID: 34529005 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11

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: Dr. Thomas Hope, MD
• Organization: University of California, San Francisco

Thomas.Hope@ucsf.edu

(415) 221-4810

Study Officials

• Thomas Hope, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiology and Biomedical Imaging

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 29, 2016
• Study Start: September 23, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: December 10, 2020
• Results First Posted: December 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)