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Trial Title:
Evaluation of the Change in PSMA Expression in Prostate Cancer in Response to Hormonal Therapy
NCT ID:
NCT05919329
Condition:
Castration Resistant Prostate Cancer
Castration Sensitive Prostate Cancer
Prostate Adenocarcinoma
Conditions: Official terms:
Prostatic Neoplasms
Hypersensitivity
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Piflufolastat
Description:
Given IV
Arm group label:
Cohort 1: CRPC
Arm group label:
Cohort 2: CSPC
Other name:
Piflufolastat F-18
Other name:
Pylarify
Other name:
18F-DCFPyL
Other name:
Fluorine F 18 DCFPyL
Intervention type:
Procedure
Intervention name:
PSMA PET/CT Scan
Description:
Undergo PSMA PET/CT
Arm group label:
Cohort 1: CRPC
Arm group label:
Cohort 2: CSPC
Other name:
Prostate-Specific Membrane Antigen PET/CT
Other name:
PSMA PET/CT
Other name:
PSMA-Positron emission tomography/CT
Intervention type:
Procedure
Intervention name:
PSMA PET/MRI scan
Description:
Undergo PET/MRI
Arm group label:
Cohort 1: CRPC
Arm group label:
Cohort 2: CSPC
Other name:
Prostate-Specific Membrane Antigen PET/MRI
Other name:
PSMA PET/MR
Other name:
PSMA-Positron emission tomography/magnetic resonance imaging
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood samples
Arm group label:
Cohort 1: CRPC
Arm group label:
Cohort 2: CSPC
Other name:
Biological Sample Collection
Other name:
Specimen Collection
Other name:
Lab draw
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Cohort 1: CRPC
Arm group label:
Cohort 2: CSPC
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 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.
Criteria for 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 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
OHSU Knight Cancer Institute
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauren Drake
Phone:
503-494-4960
Email:
RADResearch@ohsu.edu
Investigator:
Last name:
Nadine Mallak, MD
Email:
Principal Investigator
Start date:
June 25, 2024
Completion date:
September 1, 2029
Lead sponsor:
Agency:
OHSU Knight Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Oregon Health and Science University
Agency class:
Other
Collaborator:
Agency:
Progenics Pharmaceuticals, Inc.
Agency class:
Industry
Source:
OHSU Knight Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05919329
