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

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ClinicalTrials.gov Identifier: NCT05919329
Recruitment Status : Not yet recruiting
First Posted : June 26, 2023
Last Update Posted : March 26, 2024
Sponsor:
Collaborators:
Oregon Health and Science University
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Nadine Mallak, MD, OHSU Knight Cancer Institute

Study Description
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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
Castration Resistant Prostate Cancer Castration Sensitive Prostate Cancer Prostate Adenocarcinoma Drug: Piflufolastat Procedure: PSMA PET/CT Scan Procedure: PSMA PET/MRI scan Procedure: Biospecimen Collection Other: Electronic Health Record Review Phase 4

Detailed Description:

PRIMARY OBJECTIVE:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Modulation of PSMA Expression in Castration Sensitive and Castration Resistant Prostate Cancer in Response to Hormonal Therapy
Estimated Study Start Date : May 1, 2024
Estimated Primary Completion Date : September 1, 2028
Estimated Study Completion Date : September 1, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Piflufolastat
Given IV
Other Names:
  • Piflufolastat F-18
  • Pylarify
  • 18F-DCFPyL
  • Fluorine F 18 DCFPyL

Procedure: PSMA PET/CT Scan
Undergo PSMA PET/CT
Other Names:
  • Prostate-Specific Membrane Antigen PET/CT
  • PSMA PET/CT
  • PSMA-Positron emission tomography/CT

Procedure: PSMA PET/MRI scan
Undergo PET/MRI
Other Names:
  • Prostate-Specific Membrane Antigen PET/MRI
  • PSMA PET/MR
  • PSMA-Positron emission tomography/magnetic resonance imaging

Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Specimen Collection
  • Lab draw

Other: Electronic Health Record Review
Ancillary studies
Experimental: 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.
 Drug: Piflufolastat
Given IV
Other Names:
  • Piflufolastat F-18
  • Pylarify
  • 18F-DCFPyL
  • Fluorine F 18 DCFPyL

Procedure: PSMA PET/CT Scan
Undergo PSMA PET/CT
Other Names:
  • Prostate-Specific Membrane Antigen PET/CT
  • PSMA PET/CT
  • PSMA-Positron emission tomography/CT

Procedure: PSMA PET/MRI scan
Undergo PET/MRI
Other Names:
  • Prostate-Specific Membrane Antigen PET/MRI
  • PSMA PET/MR
  • PSMA-Positron emission tomography/magnetic resonance imaging

Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Specimen Collection
  • Lab draw

Other: Electronic Health Record Review
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Evaluate the change in SUVmax between baseline and Day 8 using a paired t-test to determine how hormonal therapy affects the PSMA modulation.


Secondary Outcome Measures :
  1. Change in SUVmax on post-therapy initiation PSMA PET (28 ± 3 days) compared to baseline. [ Time Frame: Baseline PSMA PET 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.

  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05919329


Contacts
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Contact: Lauren Drake 503-494-4960 RADResearch@ohsu.edu

Locations
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United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Contact: Lauren Drake    503-494-4960    RADResearch@ohsu.edu   
Principal Investigator: Nadine Mallak, MD         
Sponsors and Collaborators
OHSU Knight Cancer Institute
Oregon Health and Science University
Progenics Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Nadine Mallak, MD OHSU Knight Cancer Institute
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Nadine Mallak, MD, Principal Investigator, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT05919329    
Other Study ID Numbers: STUDY00025799
NCI-2023-06184 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: June 26, 2023    Key Record Dates
Last Update Posted: March 26, 2024
Last Verified: March 2024

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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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Hypersensitivity
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Immune System Diseases