Back to resultsEvaluation of the Change in PSMA Expression in Prostate Cancer in Response to Hormonal Therapy
Primary Purpose
Castration Resistant Prostate Cancer, Castration Sensitive Prostate Cancer
Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Piflufolastat
Positron Emission Tomography/Computed Tomography
Positron Emission Tomography/Magnetic Resonance Imaging
Biospecimen Collection
Electronic Health Record Review
Sponsored by
About this trial
This is an interventional diagnostic trial for Castration Resistant Prostate Cancer
Eligibility Criteria
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 histologically confirmed prostate adenocarcinoma. 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 four weeks of the initial PSMA PET. 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 (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.
Sites / Locations
- OHSU Knight Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1: CRPC
Cohort 2: CSPC
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in SUVmax on post-therapy initiation PSMA PET (8 ± 2 days) compared to baseline.
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.
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
Full Information
NCT ID
NCT05919329
First Posted
June 16, 2023
Last Updated
June 16, 2023
Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science University, Progenics Pharmaceuticals, Inc., a Lantheus company
1. Study Identification
Unique Protocol Identification Number
NCT05919329
Brief Title
Evaluation of the Change in PSMA Expression in Prostate Cancer in Response to Hormonal Therapy
Official Title
Modulation of PSMA Expression in Castration Sensitive and Castration Resistant Prostate Cancer in Response to Hormonal Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2028 (Anticipated)
Study Completion Date
September 1, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science University, Progenics Pharmaceuticals, Inc., a Lantheus company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. 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.
Detailed Description
PRIMARY OBJECTIVE:
I. To determine the early effects (at day 8) of hormonal therapy on PSMA modulation in patients with CSPC and 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Castration Resistant Prostate Cancer, Castration Sensitive Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1: CRPC
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2: CSPC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Piflufolastat
Other Intervention Name(s)
piflufolastat F-18, 18F-DCFPyL, Pylarify
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography/Computed Tomography
Other Intervention Name(s)
PET, PET/CT, PET Scan
Intervention Description
Undergo PSMA PET/CT
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography/Magnetic Resonance Imaging
Other Intervention Name(s)
PET/MRI, PET/MR, PET/MRI Scan
Intervention Description
Undergo PET/MRI
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Other Intervention Name(s)
Biological Sample Collection, Specimen Collection, Lab draw
Intervention Description
Undergo collection of blood samples
Intervention Type
Other
Intervention Name(s)
Electronic Health Record Review
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in SUVmax on post-therapy initiation PSMA PET (8 ± 2 days) compared to baseline.
Description
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.
Time Frame
Initiation of hormonal therapy up to 8 days after therapy initiation.
Secondary Outcome Measure Information:
Title
Change in SUVmax on post-therapy initiation PSMA PET (28 ± 3 days) compared to baseline.
Description
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
Initiation of hormonal therapy up to 28 days after therapy initiation.
Title
Number of patients in whom the tumor staging changed on PSMA PET scans obtained post-therapy initiation relative to baseline PET scan
Time Frame
Initiation of hormonal therapy up to 28 days after therapy initiation.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 histologically confirmed prostate adenocarcinoma.
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 four weeks of the initial PSMA PET.
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 (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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Drake
Phone
503-494-4960
Email
RADResearch@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadine Mallak, MD
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Drake
Phone
503-494-4960
Email
RADResearch@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Nadine Mallak, MD
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Change in PSMA Expression in Prostate Cancer in Response to Hormonal Therapy
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