PET-MaN-enza: PSMA Response in Metastasized Hormone Sensitive Prostate Cancer - Enzalutamide
Study Details
Study Description
Brief Summary
PSMA-PET/CT response measurements after LHRH agonist and upfront enzalutamide therapy in men diagnosed with de novo metastasized hormonal sensitive prostate cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- CRPC [12-24 months after start]
Development of castration-resistant prostate cancer
Secondary Outcome Measures
- Second line therapy [12-24 months after start]
Initiation of second line therapy
Eligibility Criteria
Criteria
Inclusion Criteria:
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Men >18 years of age.
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Mentally competent and understanding of benefits and potential burden of the study.
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Written and signed informed consent.
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Histological confirmed diagnosis of adenocarcinoma of the prostate.
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Indicated to start on hormonal therapy (any LHRH agonist or antagonist).
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Indicated to start on upfront therapy (enzalutamide).
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Any initial PSA.
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Any Gleason score.
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Any T-stage.
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Any N-stage.
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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:
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Concomitant malignancy (except from BCC of the skin).
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History of prior diagnosed or treated PCa.
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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.
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Any known allergy for the upfront therapy.
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Any known allergy for LHRH agonist or antagonist.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Roderick van den Bergh | Utrecht | Netherlands | 3583VS |
Sponsors and Collaborators
- UMC Utrecht
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL81959.041.22