PSMA Response in Metastasized Hormone Sensitive Prostate Cancer - Enzalutamide (PET-MaN-enza)

January 7, 2024 updated by: Roderick van den Bergh, UMC Utrecht

Individualisation of Management With Novel Upfront Therapies in Newly Diagnosed Metastasized Prostate Cancer Using (PSMA)PET/CT Imaging - Enzalutamide

PSMA-PET/CT response measurements after LHRH agonist and upfront enzalutamide therapy in men diagnosed with de novo metastasized hormonal sensitive prostate cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Rationale: Men, newly diagnosed with metastasized prostate cancer on PSMA PET/CT, who start on standard hormonal therapy, are additionally treated with either upfront chemotherapy or upfront extra androgen-receptor targeted agents ('ARTA'), as per guidelines' recommendations. The benefit in overall survival of these two options is similar, but important differences exist in patient-specific efficacy, costs, side-effects, and impact on quality of life. No predictive factors are available to individualize treatment choice. Currently, a one-size-fits-all strategy with hormonal therapy plus chemotherapy is usually followed.

Objective: To assess the predictive value of early response measurements on PSMA-PET/CT for therapy success, defined as time to development of castration-resistant prostate cancer (CRPC), in order to personalize treatment choice.

Study design: Prospective, single arm, open label, non-interventional, non-therapeutic observational cohort study.

Study population: Patients >18 years with newly diagnosed, histologically proven prostate cancer with >3 skeletal or visceral metastatic lesions on the PSMA-PET/CT, who are considered eligible for upfront therapy (enzalutamide) in addition to standard hormonal therapy.

Main study parameters/endpoints:

Primary parameter: Predictive value of early response on PSMA-PET/CT to upfront therapy, according to PERCIST criteria. Primary endpoint: Time to development of CRPC. Secondary parameters: Predictive value of early response on PSMA-PET/CT to hormonal therapy; predictive value of baseline PSMA-PET/CT, analysis of response in different subgroups of patients: e.g. high versus low tumour load, high versus low PSA, high versus low Gleason score. Secondary endpoint: Time to initiation of second line therapy after castration-resistant disease has been found.

Nature and extent of the burden and risks associated with participation, benefit, and group relatedness:

Patients will be treated according to standard of care, including baseline PSMA-PET/CT. The timing of follow-up PSMA-PET/CT imaging will be standardized. Instead of imaging at biochemical or clinical signs of disease progression, one PSMA-PET/CT will be performed after two months of hormonal therapy, one PSMA-PET/CT will be performed after two months of upfront therapy. Each PSMA-PET/CT scan will require an extra visit (2-3 hours) and a limited radiation burden after intravenous injection of PSMA. The additional information from the standardized follow-up PSMA-PET/CT scans will not be used for clinical decision-making.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3583VS
        • Recruiting
        • Roderick van den Bergh
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men >18 years of age.
  • Mentally competent and understanding of benefits and potential burden of the study.
  • Written and signed informed consent.
  • Histological confirmed diagnosis of adenocarcinoma of the prostate.
  • Indicated to start on hormonal therapy (any LHRH agonist or antagonist).
  • Indicated to start on upfront therapy (enzalutamide).
  • Any initial PSA.
  • Any Gleason score.
  • Any T-stage.
  • Any N-stage.
  • Stage M1, with multiple / high volume metastasis: More than three (>3) metastatic lesions (any combination of either lymph node metastasis outside of pelvis, bone metastasis, or visceral metastasis), as seen on PSMA-PET/CT-imaging. As these patients are treated with palliative intent.

Exclusion Criteria:

  • Concomitant malignancy (except from BCC of the skin).
  • History of prior diagnosed or treated PCa.
  • Any unrelated illness (e.g. active infection, inflammation or laboratory abnormalities) that in the judgment of the investigator will significantly affect patient's clinical status and/or outcome of the study.
  • Any known allergy for the upfront therapy.
  • Any known allergy for LHRH agonist or antagonist.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PSMA response evaluation arm
PSMA-PET/CT response evaluation, 2 months after starting hormonal therapy, 2 months after starting upfront enzalutamide therapy
Diagnostic test: PSMA-PET/CT response evaluation
PSMA-PET/CT response evaluation, 2 months after starting hormonal therapy, 2 months after starting upfront enzalutamide therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CRPC
Time Frame: 12-24 months after start
Development of castration-resistant prostate cancer
12-24 months after start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Second line therapy
Time Frame: 12-24 months after start
Initiation of second line therapy
12-24 months after start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

September 4, 2022

First Submitted That Met QC Criteria

September 10, 2022

First Posted (Actual)

September 14, 2022

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 7, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL81959.041.22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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