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PSMA-PET/CT Scans for Prostate Cancer

Phase 4

Waitlist Available

Led By Heather Jacene, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have histologically or cytologically confirmed prostate cancer, or unequivocal clinical evidence of mHSPC (eg. elevated PSA with lesions consistent with metastatic prostate cancer)

Age ≥18 years

Must not have

Systemic therapies other than ADT (GnRH/LHRH agonists or antagonists), AR pathways inhibitors (abiraterone, enzalutamide, apalutamide, darolutamide) and docetaxel are not permitted to be administered during the study period

Radiation to the prostate and/or metastatic sites prior to the 6-month PET scan is not permitted

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the time of the 18f-rhpsma-7.3 psma-pet/ct scan done 6 months after starting therapy for metastatic hormone sensitive prostate cancer

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial aims to see if regular PSMA-PET/CT scans can help doctors track how well treatments work for advanced prostate cancer and if they can help plan better treatments in the future. They want

Who is the study for?

This trial is for men with metastatic hormone-sensitive prostate cancer. Participants will receive standard care and undergo PSMA-PET/CT scans before and after 6 months of treatment to track disease response.

What is being tested?

The study tests if serial PSMA-PET/CT scans can effectively monitor the response to therapy in patients with metastatic hormone-sensitive prostate cancer, aiming to improve future treatments.

What are the potential side effects?

Since the intervention involves PET/CT scans, potential side effects may include exposure to radiation. However, specific side effects related to this procedure are not detailed in the provided information.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have confirmed prostate cancer, either through tests or clear clinical signs.

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I am 18 years old or older.

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I have metastatic hormone-sensitive prostate cancer without systemic therapy in the last 6 months.

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I agree to use birth control or abstain from sex during and 24 hours after the PSMA-PET scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on any cancer treatments except for hormone therapy or specific prostate cancer medications.

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I have not had radiation to my prostate or any cancer spread sites before a 6-month PET scan.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the time of the 18f-rhpsma-7.3 psma-pet/ct scan done 6 months after starting therapy for metastatic hormone sensitive prostate cancer

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the time of the 18f-rhpsma-7.3 psma-pet/ct scan done 6 months after starting therapy for metastatic hormone sensitive prostate cancer

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the time of the 18f-rhpsma-7.3 psma-pet/ct scan done 6 months after starting therapy for metastatic hormone sensitive prostate cancer for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients with residual PSMA-avid disease on 18F-rhPSMA7.3 PSMA PET after 6 months of treatment for metastatic hormone sensitive prostate cancer

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PSMA-PET/CT armExperimental Treatment2 Interventions

Patients will undergo 18F-rhPSMA-7.3 PSMA PET/CT scan before and after 6 months of treatment for metastatic hormone sensitive prostate cancer. Patients will undergo chart review every 3 months for 1 year after the second 18F-rhPSMA-7.3 PSMA PET/CT scan.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PET/CT

2022

Completed Phase 3

~1300

0 / 7Eligibility criteria met