Evaluation of the Change in PSMA Expression in Prostate Cancer in Response to Hormonal Therapy
NCT ID: NCT05919329
Last Updated: 2025-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
80 participants
INTERVENTIONAL
2024-06-25
2030-09-01
Brief Summary
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Detailed Description
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I. 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:
I. 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:
I. 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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.
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
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.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
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Oregon Health and Science University
OTHER
Progenics Pharmaceuticals, Inc.
INDUSTRY
OHSU Knight Cancer Institute
OTHER
Responsible Party
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Nadine Mallak, MD
Principal Investigator
Principal Investigators
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Nadine Mallak, MD
Role: PRINCIPAL_INVESTIGATOR
OHSU Knight Cancer Institute
Locations
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OHSU Knight Cancer Institute
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2023-06184
Identifier Type: REGISTRY
Identifier Source: secondary_id
STUDY00025799
Identifier Type: -
Identifier Source: org_study_id
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