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

Prostate Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05919329
• Other study ID #: STUDY00025799
• Secondary ID: NCI-2023-06184
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 1, 2024
• Est. completion date: September 1, 2029

Study information

• Verified date: March 2024
• Source: OHSU Knight Cancer Institute
• Contact: Lauren Drake
• Phone: 503-494-4960
• Email: RADResearch[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 1, 2029
• Est. primary completion date: September 1, 2028
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Castration Resistant Prostate Cancer
• Hypersensitivity
• Prostate Adenocarcinoma
• Prostatic Neoplasms

Intervention

Drug:
• Piflufolastat
Given IV

Procedure:
• PSMA PET/CT Scan
Undergo PSMA PET/CT
• PSMA PET/MRI scan
Undergo PET/MRI
• Biospecimen Collection
Undergo collection of blood samples

Other:
• Electronic Health Record Review
Ancillary studies

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	Oregon Health and Science University, Progenics Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in maximum standardized uptake value (SUVmax) on post-therapy initiation PSMA PET (8 ± 2 days) compared to baseline.	Evaluate the change in SUVmax between baseline and Day 8 using a paired t-test to determine how hormonal therapy affects the PSMA modulation.	Baseline PSMA PET up to 8 days after therapy initiation
Secondary	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.	Baseline PSMA PET up to 28 days after therapy initiation
Secondary	Number of patients in whom the tumor staging changed on PSMA PET scans obtained post-therapy initiation relative to baseline PET scan		Baseline PSMA PET up to 28 days after therapy initiation