Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

NCT02918357 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 165510NCI-2018-00039
• Study Type: interventional
• Target: 385
• 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 biochemical recurrence after prostatectomy and radiation therapy.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation

  PPVs were calculated across the group on a per-patient basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% confidence intervals (CI). The CIs were constructed using the Wilson score method.

  1 month

• Positive Predictive Value (PPV) on a Per-region Basis With Histologic Validation

  PPVs were calculated across the group on a per-region-basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% CIs. The CIs were constructed using the Wilson score method.

  1 month

Secondary Outcomes (9)

• PPVs on a Per-patient of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up

  1 month

• PPVs on a Per-region of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up

  1 month

• Sensitivity on a Per-patient Basis

  1 month

• Sensitivity on a Per-region Basis

  1 month

• Detection Rates of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value

  1 month

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:

• Histopathological proven prostate adenocarcinoma.
• Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
• Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation
• PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and,
• Confirmatory persistent PSA greater than 0.2 ng/mL
• Post-radiation therapy -ASTRO-Phoenix consensus definition
• Nadir + greater than or equal to 2 ng/mL rise in PSA
• 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:

• Investigational therapy for prostate cancer.
• Unable to lie flat, still or tolerate a PET scan.
• Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

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
• 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 27, 2016
• First Posted: September 28, 2016
• Study Start: September 15, 2016
• Primary Completion: September 21, 2017
• Study Completion: September 21, 2017
• Last Updated: December 2, 2019
• Results First Posted: December 2, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)