Recruiting

Hormonal Therapy

Sponsor:

OHSU Knight Cancer Institute

Code:

NCT05919329

Conditions

Castration Resistant Prostate Cancer

Castration Sensitive Prostate Cancer

Prostate Adenocarcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Piflufolastat

PSMA PET/CT Scan

PSMA PET/MRI scan

Biospecimen Collection

Electronic Health Record Review

Study Details

Brief summary:

This clinical trial investigates the change in prostate-specific membrane antigen (PSMA) expression in response to hormonal therapy in both, Castration Sensitive Prostate Cancer (CSPC) and Castration Resistant Prostate Cancer (CRPC), and whether this change in PSMA expression changes tumor staging after therapy initiation. Understanding these effects can help define the best timing to perform the PSMA positron emission tomography (PET) relative to the start of therapy.

Conditions

Castration Resistant Prostate Cancer

Castration Sensitive Prostate Cancer

Prostate Adenocarcinoma

Study ID

NCT05919329

Start date

Jun 25, 2024

Status verified date

Oct, 2025

Completion date

Sep 1, 2030

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Cohort 1: CRPC

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.

experimental: Cohort 2: CSPC

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.

Interventions

Piflufolastat

Given IV

PSMA PET/CT Scan

Undergo PSMA PET/CT

PSMA PET/MRI scan

Undergo PET/MRI

Biospecimen Collection

Undergo collection of blood samples

Electronic Health Record Review

Ancillary studies

Primary outcome measure

  • Change in maximum standardized uptake value (SUVmax) on post-therapy initiation PSMA PET (8 ± 2 days) compared to baseline. [ Time Frame: Baseline PSMA PET up to 8 days after therapy initiation ]

Central Contacts and Locations

Central contacts

Lauren Drake

503-494-4960RADResearch@ohsu.edu

Locations

OHSU Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Lauren Drake

503-494-4960RADResearch@ohsu.edu

Principal Investigator:

Nadine Mallak, MD

More Information

Sponsor

OHSU Knight Cancer Institute

Last update posted

Oct 24, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OHSU Knight Cancer Institute on 2025-10-24.