NCT04746300

imPlementing ROutine Molecular Characterization in Patients With Metastatic Castration Resistant ProstaTe Cancer by NGS

imPlementing ROutine Molecular Characterization in Patients With Metastatic Castration-resistant ProsTate Cancer by Next Generation DNA Sequencing (PROMPT-study)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 platinum-therapy). The investigators hypothesize that, by doing this early in the disease course (before exhausting standard of care options), it will improve treatment planning, patient outcome, quality of life, and reduce costs.

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 abiraterone and enzalutamide (targeting the androgen signaling pathway), radium-223 (bone targeting radionuclide therapy), and taxane chemotherapy. Controversy remains on optimal sequencing of available therapeutic agents, and these drugs are still commonly prescribed in a trial-and-error manner. Only a minority of patients receives the full benefit of the anticancer armamentarium, but all experience unnecessary side-effects, quality of life deterioration, and delay in onset to adequate life-prolonging treatment. In addition, the prescription of ineffective drugs and avoidable hospital admissions contribute to the financial burden of health care systems. In recent years, distinct molecular subsets of prostate cancer have been identified in mCRPC. These molecular defects may guide physicians in proper sequencing of medication and in predicting the individual response more accurately. In previous studies using next-generation sequencing (NGS) mCRPC patients could be grouped into clearly distinct molecular subtypes. Moreover, in these subtypes biomarkers associated with resistance to certain therapies, or biomarkers actually predictive for enhanced response were identified. In this study the investigators will introduce routine molecular characterization in participants with mCRPC as early as possible in their disease state. Participants will be screened before initiation of second-line treatment, since early identification will maximize clinical and financial benefit. Following screening, participants will be discussed in molecular tumor board and clinical meetings, and stratified to the agent they are most likely to respond to. Translational research is included to identify and validate additional predictive molecular biomarkers.

Conditions

• Metastatic Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Biopsy	A biopsy will be taken from metastatic tissue, which will be used for DNA sequencing
PROCEDURE	Blood sample	Blood samples will be taken for additional translational research

Timeline

• Start date: 2020-02-04
• Primary completion: 2024-02-01
• Completion: 2025-02-01
• First posted: 2021-02-09
• Last updated: 2021-02-09

Locations

1 site across 1 country: Netherlands