Gallium-68 PSMA-11 Positron Emission Tomography (PET) Imaging in Patients With Biochemical Recurrence

NCT03353740 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 175518NCI-2018-00040
• Study Type: interventional
• Target: 346
• 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 its ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (4)

• True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up

  The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the lymph nodes using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.

  1 Day

• True Positive Rate for Detection of Tumor Location in Visceral Tissue Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up

  The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the visceral tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.

  1 Day

• True Positive Rate for Detection of Tumor Location in Bone Tissue Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up

  The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the bone tissue using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.

  1 Day

• True Positive Rate for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up

  The true positive rate or detection rate (sensitivity) is defined as the proportion of all participants who have prostate cancer detected in the prostate bed using Ga68-PSMA-11, where disease location is also confirmed by histopathology/biopsy, clinical and conventional imaging follow-up. Corresponding two-sided 95% confidence intervals will be constructed using the Wilson score method.

  1 day

Secondary Outcomes (18)

• Positive Predictive Value (PPV) for Detection of Tumor Location in Lymph Nodes Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up.

  1 Day

• PPV for Detection of Tumor Location in Visceral Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up.

  1 Day

• PPV for Detection of Tumor Location in Bone Metastasis Lesions Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up.

  1 Day

• PPV for Detection of Tumor Location in Prostate Bed Confirmed by Histopathology/Biopsy, Clinical and Conventional Imaging Follow-up.

  1 Day

• True Positive Rate for Detection of Tumor Location in Lymph Nodes Confirmed by Histology/Pathology Only

  1 Day

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:

• Histopathologically proven prostate adenocarcinoma.
• Rising prostate-specific antigen (PSA) (at least two consecutive rising PSAs) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
• Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation for biochemical recurrence after radical prostatectomy
• PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP.
• Post-radiation therapy -ASTRO-Phoenix consensus definition of biochemical recurrence after radiation therapy
• Nadir + greater than or equal to 2 ng/mL rise in PSA
• Karnofsky performance status of \> 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:

• Unable to lie flat, still or tolerate a PET scan.
• Concomitant investigational therapy.
• Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.

Sponsors & Collaborators

• Thomas Hope: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (2)

• Fendler WP, Calais J, Eiber M, Simko JP, Kurhanewicz J, Santos RD, Feng FY, Reiter RE, Rettig MB, Nickols NG, Kishan AU; PSMA PET Reader Group; Slavik R, Carroll PR, Lawhn-Heath C, Herrmann K, Czernin J, Hope TA. False positive PSMA PET for tumor remnants in the irradiated prostate and other interpretation pitfalls in a prospective multi-center trial. Eur J Nucl Med Mol Imaging. 2021 Feb;48(2):501-508. doi: 10.1007/s00259-020-04945-1. Epub 2020 Aug 17.

  PMID: 32808077 DERIVED

• Fendler WP, Calais J, Eiber M, Flavell RR, Mishoe A, Feng FY, Nguyen HG, Reiter RE, Rettig MB, Okamoto S, Emmett L, Zacho HD, Ilhan H, Wetter A, Rischpler C, Schoder H, Burger IA, Gartmann J, Smith R, Small EJ, Slavik R, Carroll PR, Herrmann K, Czernin J, Hope TA. Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer: A Prospective Single-Arm Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):856-863. doi: 10.1001/jamaoncol.2019.0096.

  PMID: 30920593 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

Limitations and Caveats

Only a small sample of participants had viable tissue for histological confirmation outcomes.

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 27, 2017
• Study Start: September 20, 2017
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 21, 2021
• Results First Posted: October 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)