Modulation of PSMA Expression in Castration Sensitive and Castration Resistant Prostate Cancer in Response to Hormonal Therapy

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure, Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
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• Participant or legally authorized representative (LAR) must provide written informed consent before any study-specific procedures or interventions are performed.

• Participants must have confirmed prostate adenocarcinoma, histologically, or by combined imaging and biochemical markers.

• 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:

‣ For CSPC: GnRH agonists, GnRH antagonists, first-generation antiandrogen (e.g. bicalutamide), or androgen receptor (AR)-targeted agent (e.g. Abiraterone, Enzalutamide, Apalutamide, Darolutamide)

⁃ For CRPC: this group of patients are typically on continuous ADT (GnRH agonists or antagonists), which will be continued, and the hormonal therapy they will be started on is an androgen receptor (AR)-targeted agent (e.g. Abiraterone, Enzalutamide, Apalutamide, Darolutamide)

• 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

Locations
United States
Oregon
OHSU Knight Cancer Institute
RECRUITING
Portland
Contact Information
Primary
Lauren Drake
RADResearch@ohsu.edu
503-494-4960
Time Frame
Start Date: 2024-06-25
Estimated Completion Date: 2030-09-01
Participants
Target number of participants: 80
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: OHSU Knight Cancer Institute
Collaborators: Oregon Health and Science University, Progenics Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov