Evaluation of the Change in PSMA Expression in Prostate Cancer in Response to Hormonal Therapy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
PRIMARY OBJECTIVE:
- To determine the early effects (at day 8) of hormonal therapy on PSMA modulation in patients with CSPC and CRPC.
SECONDARY OBJECTIVES:
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To evaluate the effects of hormonal therapy on PSMA modulation at day 28 post-therapy in patients with CSPC and CRPC
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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:
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To assess whether the initial change in PSMA modulation in response to hormonal therapy holds prognostic implications
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To assess for potential correlation between the early change in PSMA modulation and tumor characteristics such as Gleason score, and site of disease.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1: CRPC Patients will receive PSMA PET prior to start of therapy (standard of care), then again 8 days and 28 days after initiation of hormonal therapy. |
Drug: Piflufolastat
Given IV
Other Names:
Procedure: Positron Emission Tomography/Computed Tomography
Undergo PSMA PET/CT
Other Names:
Procedure: Positron Emission Tomography/Magnetic Resonance Imaging
Undergo PET/MRI
Other Names:
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
Other: Electronic Health Record Review
Ancillary studies
|
| Experimental: Cohort 2: CSPC Patients will receive PSMA PET prior to start of therapy (standard of care), then again 8 days and 28 days after initiation of hormonal therapy. |
Drug: Piflufolastat
Given IV
Other Names:
Procedure: Positron Emission Tomography/Computed Tomography
Undergo PSMA PET/CT
Other Names:
Procedure: Positron Emission Tomography/Magnetic Resonance Imaging
Undergo PET/MRI
Other Names:
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
Other: Electronic Health Record Review
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Change in SUVmax on post-therapy initiation PSMA PET (8 ± 2 days) compared to baseline. [Initiation of hormonal therapy up to 8 days after therapy initiation.]
Evaluate the change in maximum standardized uptake value (SUVmax) between baseline and Day 8 using a paired t-test to determine how hormonal therapy affects the PSMA modulation.
Secondary Outcome Measures
- Change in SUVmax on post-therapy initiation PSMA PET (28 ± 3 days) compared to baseline. [Initiation of hormonal therapy up to 28 days after therapy initiation.]
Evaluate the change in SUVmax between baseline and Day 28 using a paired t-test to determine how hormonal therapy affects the PSMA modulation.
- Number of patients in whom the tumor staging changed on PSMA PET scans obtained post-therapy initiation relative to baseline PET scan [Initiation of hormonal therapy up to 28 days after therapy initiation.]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed.
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Participants must have histologically confirmed prostate adenocarcinoma.
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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.
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Participants must have sites of prostate cancer showing uptake on an initial PSMA PET scan.
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Participants are planned to receive hormonal therapy within four weeks of the initial PSMA PET.
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Life expectancy > 3 months.
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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.
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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:
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Uncontrolled serious infection.
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Intercurrent illness or condition that would limit compliance with study requirements.
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Participants who have undergone any cancer treatment (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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | OHSU Knight Cancer Institute | Portland | Oregon | United States | 97239 |
Sponsors and Collaborators
- OHSU Knight Cancer Institute
- Oregon Health and Science University
- Progenics Pharmaceuticals, Inc., a Lantheus company
Investigators
- Principal Investigator: Nadine Mallak, MD, OHSU Knight Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00025799