Gallium-68 PSMA-11 PET in Participants With Prostate Cancer

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05034562
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 1,500
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 30.8
• Patients Per Site Per Month: 48.7

Study Details

Study Description

Brief Summary

This phase II trial studies how well gallium-68 PSMA-11 PET/CT or PET/MRI works in finding prostate cancer cells that have come back (recurrent) in patients with prostate cancer. Gallium-68 PSMA-11 is a type of radioactive compound, called a radiotracer, which is injected in the vein and can accumulate in tumor cells to generate a signal detected by PET/CT or PET/MRI imaging. This may help researchers in finding recurrent prostate cancer cells in patients with prostate cancer.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Prostate Carcinoma; Recurrent Prostate Carcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8	Procedure: Computed Tomography; Drug: Gallium Ga 68-labeled PSMA-11; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography	Phase 2

Detailed Description

PRIMARY OBJECTIVE:

1. To assess the positive predictive value (PPV) of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA11) positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance imaging (PET/MRI) on a patient level using histopathology or confirmatory imaging as a standard of truth (SoT).

SECONDARY OBJECTIVES:

1. To assess the PPV per-patient for 68Ga-PSMA-11 PET/CT and PET/MRI detection of tumor location confirmed by histopathology/biopsy alone.

2. Demonstrate the safety of 68Ga-PSMA-11 PET/CT or PET/MRI imaging in participants with prostate cancer.

3. Demonstrate the efficacy of 68Ga-PSMA-11 PET/CT or PET/MRI imaging to monitor response to treatment in participants with prostate cancer.

OUTLINE:

Patients receive gallium 68Ga-PSMA-11 intravenously (IV). 50-100 minutes after injection, patients then undergo a PET/CT scan or PET/MRI scan over 60 minutes.

After completion of study, patients are followed up at 30 and 90 days, then between 3-36 months.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1500 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Gallium-68 PSMA-11 PET in Participants With Prostate Cancer
• Anticipated Study Start Date: Aug 30, 2022
• Anticipated Primary Completion Date: Mar 25, 2025
• Anticipated Study Completion Date: Mar 25, 2025

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Diagnostic (gallium Ga 68-labeled PSMA-11, PET/CT, PET/MRI) Patients receive gallium Ga 68-labeled PSMA-11 IV. 50-100 minutes after injection, patients then undergo a PET/CT scan or PET/MRI scan over 60 minutes.

Procedure: Computed Tomography; Undergo PET/CT; Other Names: CAT CAT Scan Computerized Axial Tomography Computerized Tomography CT CT Scan tomography ; Drug: Gallium Ga 68-labeled PSMA-11; Given IV; Other Names: (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC (68Ga)Glu-urea-Lys(Ahx)-HBED-CC 68Ga-DKFZ-PSMA-11 68Ga-HBED-CC-PSMA 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC 68Ga-PSMA 68Ga-PSMA-11 68Ga-PSMA-HBED-CC [68Ga] Prostate-specific Membrane Antigen 11 [68Ga]GaPSMA-11 Ga PSMA Ga-68 labeled DKFZ-PSMA-11 Ga-68 labeled PSMA-11 Gallium Ga 68 PSMA-11 Gallium-68 PSMA Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC GaPSMA PSMA-HBED-CC GA-68 ; Procedure: Magnetic Resonance Imaging; Undergo PET/MRI; Other Names: Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR Imaging MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging ; Procedure: Positron Emission Tomography; Undergo PET/CT or PET/MRI; Other Names: Medical Imaging, Positron Emission Tomography PET PET Scan Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging

Outcome Measures

Primary Outcome Measures

1. Positive predictive value of 68Ga-PSMA-11 (gallium Ga 68-labeled PSMA-11) positron emission tomography (PET) [Up to 36 months]

   Positive predictive value will be defined as true positive/(true positive + false positive). Positive predictive value on a per-participant and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up will be calculated and reported along with the corresponding two-sided 95% confidence intervals.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Pathologically proven prostate cancer

• Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)

• Karnofsky performance status (KPS) >= 50 (Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] 0, 1, or 2)

• Ability to understand and willingness to provide informed consent

• Participants with known metastatic prostate cancer planned to undergo active systemic treatment

Exclusion Criteria:

• Unable to lie flat, still, or tolerate a PET or MRI scan

• Contraindication to optional furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. This exclusion criteria can be removed if furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction - (defined as either Ga-68 specific prompt gamma correction or multiple scatter model) is available for the used PET device

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Gregory C Ravizzini, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• MD Anderson Cancer Center

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT05034562
• Other Study ID Numbers: 2019-1203; NCI-2020-03699; 2019-1203
• First Posted: Sep 5, 2021
• Last Update Posted: Jul 12, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Prostatic Neoplasms; Edetic Acid; Gallium 68 PSMA-11

Study Results

No Results Posted as of Jul 12, 2022