Evaluating PSMA Changes in Prostate Cancer After Hormonal Therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates how hormonal therapy affects prostate-specific membrane antigen (PSMA) expression in patients with both Castration Sensitive Prostate Cancer (CSPC) and Castration Resistant Prostate Cancer (CRPC). The study aims to assess PSMA modulation at two time points: 8 days and 28 days after therapy initiation. Additionally, it will evaluate whether changes in PSMA expression influence tumor staging as determined by PSMA PET imaging. Participants will be monitored for up to 5 years to gather comprehensive data on the effects of hormonal therapy on PSMA levels and their prognostic implications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed.
* Participants must have confirmed prostate adenocarcinoma, histologically, or by combined imaging and biochemical markers.
* Age \>= 18 years. Given the nature of the disease in question, only men will be included. Members of all races and ethnic groups will be included.
* Participants must have sites of prostate cancer showing uptake on an initial PSMA PET scan.
* Participants are planned to receive hormonal therapy within eight weeks of the initial PSMA PET. The hormonal therapy agents include:

  * For CSPC: GnRH agonists, GnRH antagonists, first-generation antiandrogen (e.g. bicalutamide), or androgen receptor (AR)-targeted agent (e.g. Abiraterone, Enzalutamide, Apalutamide, Darolutamide)
  * For CRPC: this group of patients are typically on continuous ADT (GnRH agonists or antagonists), which will be continued, and the hormonal therapy they will be started on is an androgen receptor (AR)-targeted agent (e.g. Abiraterone, Enzalutamide, Apalutamide, Darolutamide)
* Life expectancy \> 3 months.
* Cohort 1: Castration resistant prostate cancer with rising PSA (confirmed by two PSA values at least 1 week apart), testosterone \< 50 ng/dL, on continuous ADT at least 4 months, no AR targeted agent in the prior 4 months.
* Cohort 2: Castration sensitive prostate cancer with no ADT or AR targeted agents use in the past 12 months, testosterone \>50 ng/dL

Exclusion Criteria:

* Uncontrolled serious infection.
* Intercurrent illness or condition that would limit compliance with study requirements.
* Participants who have undergone any cancer treatment other than the hormonal therapy (systemic or radiation therapy) or who have started any supplements or herbal medications intended to treat cancer between the baseline PSMA PET and PSMA PET at day 28.

Where it's running

• OHSU Knight Cancer Institute
  Portland, Oregon, United States Recruiting

Study contacts

• Principal investigator: Nadine Mallak, MD — OHSU Knight Cancer Institute
• Study coordinator: Lauren Drake
• Email: RADResearch@ohsu.edu
• Phone: 503-494-4960

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.