Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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 eight weeks of the initial PSMA PET. The hormonal therapy agents include:
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
Primary purpose
Allocation
Interventional model
Masking
80 participants in 2 patient groups
Loading...
Central trial contact
Lauren Drake
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal