68Ga-PSMA-11 PET in Patients With Prostate Cancer

NCT05197257 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 21-4070.cc
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging study.

Conditions

Prostate Cancer; Prostate Adenocarcinoma

Keywords

Newly Diagnosed

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Adverse Events (AEs) will be collected and reviewed to monitor for safety. Incidence and severity of AEs and adverse events will be estimated with 95% confidence intervals summarized with descriptive statistics. CTCAE version 5.0 will be used to grade AEs.

  Immediately after administration and for 1 hour and 30 minutes afterwards

Secondary Outcomes (1)

• Compare the Diagnostic Impact of 68Ga-PSMA-11 PET/CT Imaging Over Current Standard of Care Imaging Modalities.

  2 hours

Study Arms (1)

Men with pathologically proven prostate adenocarcinoma

EXPERIMENTAL

The intervention is a PET scan with the radiolabelled PSMA ligand, 68Ga-PSMA-11. The PET may be combined with a CT scan as a PET/CT or an MRI scan as PET/MRI. 68Ga-PSMA-11 PET/CT will be acquired using a modern digital GE PET/CT scanner or a modern digital PET / MRI scanner.

Drug: Ga-PSMA-11

Interventions

Ga-PSMA-11 DRUG

The PSMA Sterile Cold Kit, is a kit comprising all needed materials (lyophilized PSMA for PSMA reconstitution, elution vial for Ga and ancillary materials for transfer between vials) to perform a room-temperature radiolabelling of PSMA-11 with Ga. Ga is not part of the kit and should be provided in the form gallium chloride solution following the requirements of the relevant local regulations. PSMA-11 radiolabelled with Ga is administered in patients with prostate cancer recurrence after radical treatment.

Men with pathologically proven prostate adenocarcinoma

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathologically proven prostate adenocarcinoma
• Age ≥ 18 years
• Patients already diagnosed with prostate cancer: Primary Staging: intermediate and high-risk patients per NCCN guidelines
• Biochemical Recurrence: Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy):
• a. Post radical prostatectomy (RP) - AUA recommendation i. PSA greater than or equal to 0.2 ng/mL measured more than 6-13 weeks after RP and confirmed by a second determination of a PSA level of \>0.2 ng/mL b. Post-radiation therapy - ASTRO-Phoenix consensus definition i. Nadir + greater than or equal to 2 ng/mL rise in PSA
• 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/CT scan, or any other condition that would preclude PET/CT imaging.
• Patients with any medical condition or circumstance that the investigator believes may compromise the data collection or lead to a failure to fulfil the study requirements.
• Patients with known hypersensitivity to the active substance or to any of the excipients of the investigational product.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (2)

Colorado Research Center

Aurora, Colorado, 80045, United States

Location

UCHealth-Metro Denver

Denver, Colorado, 80217-3364, United States

Location

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: Dr. Bennett Chin
• Organization: University of Colorado

Bennett.Chin@cuanschutz.edu

720-848-0000

Study Officials

• Bennett Chin

  Colorado Research Center

  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

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 19, 2022
• Study Start: September 29, 2021
• Primary Completion: April 14, 2022
• Study Completion: April 14, 2022
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)