Status:
UNKNOWN
imPlementing ROutine Molecular Characterization in Patients With Metastatic Castration Resistant ProstaTe Cancer by NGS
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
VGZ health insurance (NL)
Paul Speth Foundation (NL)
Conditions:
Metastatic Prostate Cancer
Eligibility:
MALE
18+ years
Brief Summary
The PROMPT study aims to routinely implement genomic pre-sorting of metastatic castration-resistant prostate cancer (mCRPC) patients for personalized treatment (e.g. immuno-, PARP inhibitors, or plati...
Detailed Description
Prostate cancer is a major health problem leading to significant morbidity and mortality in men worldwide. Approved therapies for metastatic castration-resistant prostate cancer (mCRPC) include abirat...
Eligibility Criteria
Inclusion
- Male aged 18 or older with adenocarcinoma of the prostate defined by: Documented histopathology at diagnosis of prostate adenocarcinoma without evidence of predominant or primary neuroendocrine histology.
- Patients with a metastatic tumor site accessible for image-guided biopsy and allowing research analyses for this trial (e.g. biomarker testing by genomic, proteomic or transcriptomic assessment). A waiver can be made for patients presenting with metastatic hormone-sensitive prostate cancer (mHSPC), and no easily accessible tumour for biopsy and suitable primary tissue available for NGS.
- Castration-resistant state (defined as disease progressing despite \[chemical\] castration per PCWG3 criteria)
- Progressive disease as either
- A rising PSA on minimum 2 serial consecutive measurements
- Radiographic soft tissue progression per RECIST1.1 or bone progression per PCWG3 criteria
- Clinical progression
- At least one metastatic lesion present at baseline CT, MRI, 68Ga/18F-PSMA PET or bone scan
- ECOG Performance status 0 to 2
- Serum testosterone on castration level
- Adequate renal function:
- • MDRD-GFR ≥ 30 ml/min/1.73m2
- Adequate bone marrow function:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x109/L
- Hemoglobin (Hb) ≥ 5.6 mmol/L
- Adequate liver function:
- Total bilirubin level ≤ 2 institutional upper limit of the normal (ULN)
- Aspartate aminotransferase (ASAT) ≤ 3 x ULN (or ≤ 5x ULN in case of known liver metastases)
- Alanine aminotransferase (ALAT) ≤ 3 x ULN (or ≤ 5x ULN in case of known liver metastases)
- Estimated life expectancy \> 12 months
- Willing and able to comply to the research protocol
- Signed, written informed consent
Exclusion
- Prior chemotherapy and androgen receptor inhibition therapy related to castration resistant prostate cancer (one line of chemotherapy or androgen receptor inhibition may be given in the hormone-sensitive setting)
- Active malignancy other than prostate cancer, except for patients with basal or squamous skin cancer. A waiver may be obtained from the PI in cases where the active malignancy is indolent and believed not to reduce mortality.
- Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI).
- Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse
- Any condition which, in the opinion of the investigator, would preclude participation in this observational study.
Key Trial Info
Start Date :
February 4 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04746300
Start Date
February 4 2020
End Date
February 1 2025
Last Update
February 9 2021
Active Locations (1)
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1
Radboud UMC
Nijmegen, Gelderland, Netherlands, 6500HB