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Hormone Therapy

Hormonal Therapy Impact on PSMA Expression in Prostate Cancer

Phase 4

Recruiting

Led By Nadine Mallak, MD

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline psma pet up to 8 days after therapy initiation

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial looks at how hormonal therapy affects prostate cancer and how it can help determine the best time to do a PET scan.

Who is the study for?

This trial is for men aged 18 or older with confirmed prostate adenocarcinoma, who show PSMA uptake on initial scans and are about to start hormonal therapy. It includes those with castration sensitive (CSPC) or resistant (CRPC) prostate cancer, but excludes anyone who's had recent cancer treatment or started supplements/herbal meds aimed at treating cancer.

What is being tested?

The study is examining how hormone therapy affects PSMA levels in prostate cancer patients and if this changes tumor staging post-therapy. Participants will undergo PSMA PET/MRI or CT scans before and after starting hormonal treatments to track these changes.

What are the potential side effects?

While the trial primarily involves imaging tests like PSMA PET/MRI and CT scans which have minimal side effects such as discomfort from lying still, potential risks include exposure to radiation. Hormonal therapies may cause fatigue, hot flashes, reduced sexual desire, and other hormone-related effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline psma pet up to 8 days after therapy initiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline psma pet up to 8 days after therapy initiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline psma pet up to 8 days after therapy initiation for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in maximum standardized uptake value (SUVmax) on post-therapy initiation PSMA PET (8 ± 2 days) compared to baseline.

Secondary study objectives

Change in SUVmax on post-therapy initiation PSMA PET (28 ± 3 days) compared to baseline.

Awards & Highlights

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.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2: CSPCExperimental Treatment5 Interventions

Patients with CSPC will receive 18F-DCFPyL PET prior to start of therapy (standard of care), then again 8 days and 28 days after initiation of hormonal therapy.

Group II: Cohort 1: CRPCExperimental Treatment5 Interventions

Patients with CRPC will receive 18F-DCFPyL PET prior to start of therapy (standard of care), then again 8 days and 28 days after initiation of hormonal therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

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