Prostate Cancer
Conditions
Keywords
psma, response, metastasis, upfront
Brief summary
PSMA-PET/CT response measurements after LHRH agonist and upfront therapy in men diagnosed with de novo metastasized hormonal sensitive prostate cancer.
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 (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.
Interventions
DIAGNOSTIC_TESTPSMA-PET/CT
PSMA-PET/CT
Sponsors
Roderick van den Bergh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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 (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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CRPC | 18-24 mo after inclusion | Development of castration-resistant prostate cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2nd line therapy | 18-24 mo after inclusion | Initiation of second line therapy for CRPC |
Countries
Netherlands
Contacts
Primary ContactRoderick van den Bergh, MD PhD
Outcome results
None listed