PSMA Response in Metastasized Hormone Sensitive Prostate Cancer
NCT ID: NCT05161728
Last Updated: 2024-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2021-10-19
2025-10-19
Brief Summary
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Detailed Description
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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 (apalutamide or abiraterone) 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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PSMA response evaluation arm
PSMA-PET/CT response evaluation, 2 months after starting hormonal therapy, 2 months after starting upfront therapy
PSMA-PET/CT
PSMA-PET/CT
Interventions
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PSMA-PET/CT
PSMA-PET/CT
Eligibility Criteria
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Inclusion Criteria
* 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 (apalutamide or abiraterone).
* 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
* 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.
18 Years
MALE
No
Sponsors
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Roderick van den Bergh
OTHER
Responsible Party
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Roderick van den Bergh
Dr. Roderick CN van den Bergh
Principal Investigators
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Marnix Lam, MD PhD
Role: STUDY_CHAIR
UMC Utrecht
Locations
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Meander MC
Amersfoort, , Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen, , Netherlands
St Antonius Ziekenhuis
Utrecht, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NL77093.041.21
Identifier Type: -
Identifier Source: org_study_id
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