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

ConditionsCastration Resistant Prostate CancerCastration Sensitive Prostate CancerProstate Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18+
SponsorOHSU Knight Cancer Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Piflufolastat

    Drug

    Given IV

  • PSMA PET/CT Scan

    Procedure/Surgery

    Undergo PSMA PET/CT

  • PSMA PET/MRI scan

    Procedure/Surgery

    Undergo PET/MRI

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood samples

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Cohort 1: CRPCExperimental treatment 5 interventions
Group B: Cohort 2: CSPCExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

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.

Time frame
Baseline PSMA PET up to 8 days after therapy initiation

Secondary outcomes

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.

Time frame
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

Time frame
Baseline PSMA PET up to 28 days after therapy initiation

Other outcomes

Sponsors and contacts

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OHSU Knight Cancer Institute

Lead sponsor

Oregon Health and Science University

Collaborator

Progenics Pharmaceuticals, Inc.

Collaborator

Source ClinicalTrials.gov
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