AzTrials
AzTrials

Castration Resistant Prostate CancerPhase 4NCT05919329

Evaluation of the Change in PSMA Expression in Prostate Cancer in Response to Hormonal Therapy

A Phase 4 study testing Piflufolastat, PSMA PET/CT Scan and PSMA PET/MRI scan in people with Castration Resistant Prostate Cancer and Castration Sensitive Prostate Cancer, run by OHSU Knight Cancer Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Piflufolastat, PSMA PET/CT Scan and PSMA PET/MRI scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
25 Jun 2024to 1 Sep 2030
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lauren Drake contact

503-494-4960

RADResearch@ohsu.edu

United States1 site, 1 recruiting

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

    Lauren Drake, 503-494-4960, RADResearch@ohsu.edu

    Nadine Mallak, MD

    Recruiting

Other trials in United States

About this study

Official title: Modulation of PSMA Expression in Castration Sensitive and Castration Resistant Prostate Cancer in Response to Hormonal Therapy

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the early effects (at day 8) of hormonal therapy on PSMA modulation in patients with castration sensitive prostate cancer (CSPC) and castration resistant prostate cancer (CRPC)

SECONDARY OBJECTIVES:

  1. To evaluate the effects of hormonal therapy on PSMA modulation at day 28 post-therapy in patients with CSPC and CRPC

II. To evaluate whether the change in PSMA modulation after hormonal therapy initiation changes the tumor staging on PSMA PET as defined by the PROMISE V2 criteria.

EXPLORATORY OBJECTIVES:

  1. To assess whether the initial change in PSMA modulation in response to hormonal therapy holds prognostic implications

II. To assess for potential correlation between the early change in PSMA modulation and tumor characteristics such as Gleason score, and site of disease.

III. To assess whether the baseline level of PSMA uptake holds prognostic implications in response to hormonal therapy

OUTLINE:

Patients will be divided (non-randomized) into 2 groups (CRPC or CSPC) and receive PSMA PET prior to start of therapy (standard of care), then again 8 days and 28 days after initiation of hormonal therapy.

Participants will be followed for up to 5 years.

Being tested
Piflufolastat, PSMA PET/CT Scan, PSMA PET/MRI scan, Biospecimen Collection, Electronic Health Record Review

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PiflufolastatDrug

    Also called Piflufolastat F-18, Pylarify, 18F-DCFPyL, Fluorine F 18 DCFPyL

    Given IV

  • PSMA PET/CT ScanProcedure or surgery

    Also called Prostate-Specific Membrane Antigen PET/CT, PSMA PET/CT, PSMA-Positron emission tomography/CT

    Undergo PSMA PET/CT

  • PSMA PET/MRI scanProcedure or surgery

    Also called Prostate-Specific Membrane Antigen PET/MRI, PSMA PET/MR, PSMA-Positron emission tomography/magnetic resonance imaging

    Undergo PET/MRI

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Specimen Collection, Lab draw

    Undergo collection of blood samples

  • Electronic Health Record ReviewOther

    Ancillary studies

Study groups in NCT05919329
Study groupRoleWhat they receive
Cohort 1: CRPCExperimentalPatients 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.
Receives: Drug: Piflufolastat; Procedure: PSMA PET/CT Scan; Procedure: PSMA PET/MRI scan; Procedure: Biospecimen Collection; Other: Electronic Health Record Review
Cohort 2: CSPCExperimentalPatients 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.
Receives: Drug: Piflufolastat; Procedure: PSMA PET/CT Scan; Procedure: PSMA PET/MRI scan; Procedure: Biospecimen Collection; Other: Electronic Health Record Review

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Evaluate the change in SUVmax between baseline and Day 8 using a paired t-test to determine how hormonal therapy affects the PSMA modulation.

    Measured: Baseline PSMA PET up to 8 days after therapy initiation

Secondary outcomes (2)

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

    Evaluate the change in SUVmax between baseline and Day 28 using a paired t-test to determine how hormonal therapy affects the PSMA modulation.

    Measured: Baseline PSMA PET up to 28 days after therapy initiation

  2. Number of patients in whom the tumor staging changed on PSMA PET scans obtained post-therapy initiation relative to baseline PET scan

    Measured: Baseline PSMA PET up to 28 days after therapy initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2023
  2. Study start25 Jun 2024
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Sep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05919329
Sponsor's protocol ID
STUDY00025799
Other IDs
NCI-2023-06184
Status last verified
Oct 2026
First submitted
16 Jun 2023
Last updated
20 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Piflufolastat, PSMA PET/CT Scan and PSMA PET/MRI scan in people with Castration Resistant Prostate Cancer and Castration Sensitive Prostate Cancer, run by OHSU Knight Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lauren Drake (503-494-4960, RADResearch@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05919329.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in