At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed adenocarcinoma, or PSA >100 ng/ml with radiographic metastatic disease
- ✓Metastatic disease by conventional imaging at ADT initiation
- ✓PSA ≥2.0 ng/ml prior to ADT commencement for histologically confirmed patients
- ✓Recovery from treatment toxicities prior to enrollment unless grade ≤1, irreversible, or not clinically significant
- ✕Confirmed PSA progression defined by 25% increase above nadir, absolute 2.0 ng/ml increase, and further 25% increase separated by ≥3 weeks
- ✕Evidence of confirmed radiographic or clinical progression since ADT start, except bone lesions as flare or treatment effect
- ✕Prior taxane chemotherapy
- ✕Grade 2 or worse peripheral neuropathy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase III Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response
In Brief
A Phase 3 clinical trial evaluating Abiraterone, Enzalutamide, and 4 other interventions for Prostate Cancer (Adenocarcinoma). Currently recruiting, targeting 830 participants across 368 sites in 2 countries.
Signals
Detailed Summary
This study is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs? This study would like to find out if this approach is better or worse than the usual approach for prostate cancer. The usual approach for patients who are not in a study is hormone treatment with Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitor (ARPI).
Study Details
Timeline
Arms & Interventions
Interventions
Assigned prior to enrollment
Assigned prior to enrollment
Assigned prior to enrollment
Assigned prior to enrollment
Assigned at enrollment
Physician's choice. Assigned prior to enrollment