68GA-PSMA-11 PET/CT Scan in Impacting Treatment Strategies for Patients With Prostate Cancer

NCT ID: NCT04050215

Last Updated: 2021-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 937 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-02
• Study Completion Date: 2021-09-27

Brief Summary

This phase II trial studies the impact of 68GA-PSMA-11 positron emission tomography (PET)/computed tomography (CT) scan on treatment strategies for patients with prostate cancer. Diagnostic imaging procedures, such as 68GA-PSMA-11 PET/CT scan, may help doctors plan the best treatment for prostate cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the impact of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) PET/CT on initial and subsequent treatment strategies of patients with prostate cancer.

OUTLINE:

Patients receive 68Ga-PSMA-11 intravenously (IV) and undergo PET/CT scan over 3 hours. Patients may be reenrolled in the study, if 68Ga-PSMA-11 PET/CT is performed for subsequent management decision.

After completion of study, patients are followed up within 3-12 months.

Conditions

Biochemically Recurrent Prostate Carcinoma; Metastatic Prostate Carcinoma; Prostate Adenocarcinoma; Prostate Carcinoma; PSA Level Greater Than Fifty; PSA Progression; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic (68Ga-PSMA-11 PET/CT)

Patients receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 3 hours. Patients may be reenrolled in the study, if 68Ga-PSMA-11 PET/CT is performed for subsequent management decision.

Group Type: EXPERIMENTAL

Computed Tomography

Intervention Type: PROCEDURE

Undergo PET/CT

Gallium Ga 68-labeled PSMA-11

Intervention Type: DRUG

Given IV

Positron Emission Tomography

Intervention Type: PROCEDURE

Undergo PET/CT

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Computed Tomography

Undergo PET/CT

Intervention Type: PROCEDURE

Gallium Ga 68-labeled PSMA-11

Given IV

Intervention Type: DRUG

Positron Emission Tomography

Undergo PET/CT

Intervention Type: PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

CAT; CAT Scan; Computerized Axial Tomography; computerized tomography; CT; CT SCAN; tomography; (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; Medical Imaging, Positron Emission Tomography; PET; PET Scan; Positron Emission Tomography Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging

Eligibility Criteria

Inclusion Criteria

• Patients who fulfill criteria for initial staging or restaging as outlined below:

• Initial treatment strategy decisions (initial staging): All patients with histologically proven prostate cancer or strong suspicion of prostate adenocarcinoma based on very high prostate-specific antigen (PSA) levels (> 50 ng/mL) who require an initial treatment/management decision who may be candidate for any of the following strategies:

• Surgery
• External radiation therapy (RT)
• Other focal therapies
• Systemic medical treatment
• Watchful waiting
• Assessment for subsequent treatment strategy (restaging), any of the following:

• Patients with biochemical recurrence who are potential candidates for any salvage treatment. Biochemical recurrence is defined by rising PSA after definitive therapy with prostatectomy or radiation therapy, as any of the following:

• Post radical prostatectomy (RP): PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP
• Post-radiation therapy: Nadir + greater than or equal to 2 ng/mL rise in PSA
• Patients with known prostate cancer who undergo restaging because of new symptoms
• Patients with known metastatic prostate cancer who undergo restaging because of rising PSA with negative or inconclusive conventional imaging
• Patients with known prostate cancer who are treated medically or with radioligand therapy (RLT) in whom response to treatment is assessed
• Note: Patients may be reenrolled in the study, if 68Ga-PSMA PET/CT is performed for subsequent management decision
• Capability to provide written informed consent
• Able to remain still for duration of each imaging procedure (about 30 minutes)

Exclusion Criteria

• Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
• Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
• Inability to provide written informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeremie Calais

Role: PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Locations

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

References

Ma TM, Gafita A, Shabsovich D, Juarez J, Grogan TR, Thin P, Armstrong W, Sonni I, Nguyen K, Lok V, Reiter RE, Rettig MB, Steinberg ML, Kupelian PA, Yang DD, Muralidhar V, Chu C, Feng F, Savjani R, Deng J, Parikh NR, Nickols NG, Elashoff D, Czernin J, Calais J, Kishan AU. Identifying the Best Candidates for Prostate-specific Membrane Antigen Positron Emission Tomography/Computed Tomography as the Primary Staging Approach Among Men with High-risk Prostate Cancer and Negative Conventional Imaging. Eur Urol Oncol. 2022 Feb;5(1):100-103. doi: 10.1016/j.euo.2021.01.006. Epub 2021 Feb 16.

Reference Type: DERIVED

PMID: 33602654 (View on PubMed)

Other Identifiers

NCI-2019-04439

Identifier Type: REGISTRY

Identifier Source: secondary_id

17-001336

Identifier Type: -

Identifier Source: org_study_id