At a glance
ClinicalIndex Comparison Record- ✓Males 18 years or older
- ✓Histologically confirmed prostate adenocarcinoma without small cell differentiation at initial diagnosis
- ✓High-risk localized prostate cancer defined by PSA >20, Gleason score >8, or specific Gleason pattern criteria
- ✓Gleason pattern 4 in 6+ systematic cores with ≥50% average
- ✕More than 30 days of LHRHa prior to registration
- ✕Stage T4 prostate cancer by clinical examination or radiologic evaluation
- ✕Hypogonadism or severe androgen deficiency with testosterone >50 ng/dL below normal range
- ✕Active infection or chronic liver disease requiring systemic therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT04812366Phase 2RecruitingMonitorUpdated 18mo ago · Completion was 3mo agoGenomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating Apalutamide 60mg Tab, Abiraterone Acetate 250mg, and 4 other interventions for Prostate Cancer. Currently recruiting, targeting 315 participants across 9 sites in 2 countries.
Signals
Detailed Summary
The objective of this study is to see if providing an appropriate therapy based on the genomic testing of prostate tumour tissue will result in an improved clinical response. Each participant will be treated with 8 weeks of a luteinizing hormone-releasing hormone agonist (LHRHa) plus apalutamide (APA) while genome sequence characterization is being done. Participants with biopsy specimens deemed unevaluable for genomic testing will remain on LHRHa plus APA for an additional 16 weeks. Participants with evaluable tissue will be assigned to one of the open-label sub-studies on the basis of genomic profiling results. Within each group, they will be randomized to a specific treatment arm either LHRHa plus APA alone or adding abiraterone acetate and prednisone, docetaxel or niraparib. The study will evaluate the response rate and outcomes after radical prostatectomy in each arm of the trial.
Study Details
Timeline
Interventions
4 tablets by mouth once a day for 24 weeks
4 tablets by mouth on an empty stomach once a day for 16 weeks
1 tablet by mouth once daily while taking abiraterone acetate
Infusion every 3 weeks for 6 cycles (each cycle has 3 weeks)
3 capsules by mouth once daily for 16 weeks
1200mg infusion every 3 weeks for 6 cycles