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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05547386
Other study ID # 22-003732
Secondary ID NCI-2022-04135
Status Completed
Phase Phase 3
First received
Last updated
Start date May 9, 2022
Est. completion date December 31, 2023

Study information

Verified date January 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase III study provides access to 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) imaging for patients with castrate-resistant prostate cancer that has spread to other places in the body (metastatic) being considered for177Lu-PSMA-617 therapy. T PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of this tracer. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Combining a PET scan with a CT scan can help make the images easier to interpret. The 68Ga-PSMA-11 PET/CT scan is done with a very small amount of radioactive tracer call 68- gallium PSMA-11. In patients that have been diagnosed with prostate cancer, a protein called prostate-specific membrane antigen (PSMA) appears in large amounts on the surface of the cancerous cells. The radioactive imaging agent (68Ga-PSMA-11) has been designed to circulate through the body and attach itself to the PSMA protein on prostate cancer cells. A PET/CT scan is then used to detect the location of prostate cancer lesions. By gaining access to 68Ga-PSMA-11 PET/CT scans, patients may be safely screened for 177Lu-PSMA-617 therapy in the treatment of metastatic castrate resistant prostate cancer.


Description:

PRIMARY OBJECTIVE: I. To overcome a clinical access issue that would otherwise block patients from reimbursement of a new cancer therapy, and therefore block or significantly delay their care. OUTLINE: Patients receive gallium Ga 68 gozetotide intravenously (IV) and then undergo a positron emission tomography (PET)/computed tomography (CT) scan throughout the trial.


Recruitment information / eligibility

Status Completed
Enrollment 163
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - An adult male patient who is actively under the care of a medical oncology, radiation oncology or urology physician at Mayo Clinic - An adult male patient who is deemed eligible (or potentially/likely eligible) for PSMA-targeted radionuclide therapy by a nuclear medicine physician or Radiologist in the nuclear medicine therapy practice, or by the Prostate Theranostic Tumor Board (PTuB) - Eligibility will be documented in the medical record by the clinical practice - It is acceptable for the patient to be eligible for PSMA-targeted radionuclide therapy in all regards except for having completed a PSMA-targeted PET scan showing PSMA-positive prostate cancer - It is acceptable for a patient to be potentially eligible for therapy, but have a relative contraindication, such as a minor laboratory abnormality, and be on the list for discussion at the PTuB in the future - An adult male patient who has not received a 68Ga-PSMA-11 PET/CT or PET/magnetic resonance (MR), or for whom a repeat 68Ga-PSMA-11 PET/CT exam is needed per the clinical practice to ensure eligibility - An adult male patient who does not otherwise have access to a reimbursable clinical 68Ga-PSMA-11 PET scan - An adult above the ages of 18 Exclusion Criteria: - A patient who is unable to consent per Mayo guidelines - A patient who is unable to lay still, or otherwise successfully complete the imaging exam

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Computed Tomography
Undergo PET/CT scan
Drug:
Gallium Ga 68 Gozetotide
Given IV
Procedure:
Positron Emission Tomography
Undergo PET/CT scan

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety of gallium Ga 68 gozetotide (68Ga-prostate-specific membrane antigen [PSMA)]-11) Monitoring of patients for self-reported unexpected adverse reactions from the time of injection until the time they leave the care of the division of nuclear medicine. If any adverse reactions are reported, the patient will be evaluated by a nurse and/or physician and will receive appropriate care. The principal investigator (PI) or those designated by the PI will ascertain the severity of the adverse event and how likely the adverse reaction was associated with the injected 68Ga-PSMA-11. After imaging scan is complete - up to 1 day
See also
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Active, not recruiting NCT02522715 - Enzalutamide and Cabazitaxel in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer Phase 1/Phase 2
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Active, not recruiting NCT04514484 - Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV Phase 1
Active, not recruiting NCT05241860 - Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM) Phase 2
Terminated NCT02985021 - Docetaxel and Carboplatin for Patients With mCRPC and DNA-Repair Deficiencies Phase 2
Not yet recruiting NCT05487846 - Peer Navigation for the Support of Metastatic Prostate Cancer Patients Undergoing Genetic Evaluation N/A
Recruiting NCT04159896 - ESK981 and Nivolumab for the Treatment of Metastatic Castration Resistant Prostate Cancer Phase 2
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Active, not recruiting NCT03517969 - M6620 and Carboplatin With or Without Docetaxel in Treating Patients With Metastatic Castration-Resistant Prostate Cancer Phase 2

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