Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to assess the strategy in treatment selection using ctDNA fraction as a predictive biomarker to direct treatment decision (ctDNA fraction <2% receives enzalutamide, and ctDNA fraction ≥2% receives docetaxel) versus clinician's choice of enzalutamide or docetaxel, in subjects with metastatic castration-resistant prostate cancer post abiraterone setting.


Clinical Trial Description

This is a prospective, open-label, phase II trial with 1:1 randomization to either Arm A biomarker directed therapy (patients with ctDNA fraction <2% receive enzalutamide, and ctDNA fraction ≥2% receive docetaxel), versus Arm B clinician's choice of enzalutamide or docetaxel, in subjects with metastatic castration-resistant prostate cancer post abiraterone. At time of progression, patient will cross-over to the other therapy (e.g., enzalutamide to docetaxel, and docetaxel to enzalutamide). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04015622
Study type Interventional
Source British Columbia Cancer Agency
Contact Kim N Chi, MD
Phone 6048776000
Email kchi@bccancer.bc.ca
Status Recruiting
Phase Phase 2
Start date October 7, 2020
Completion date December 1, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Completed NCT01977651 - A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide Phase 4
Recruiting NCT06344715 - Phase 1 Study Evaluating Safety and Tolerability of SL-T10, GX-I7, and Pembrolizumab Triple Combination in mCRPC. Phase 1
Recruiting NCT05983198 - A Phase I/II, Open-label, Multi-center Study of [225Ac]Ac-PSMA-R2 in Men With PSMA-positive Prostate Cancer With or Without Prior 177Lu-PSMA Radioligand Therapy. Phase 1/Phase 2
Not yet recruiting NCT06134232 - Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T Phase 3
Recruiting NCT06126731 - Combination Study of Antibiotics With Enzalutamide (PROMIZE) Phase 1/Phase 2
Recruiting NCT05806814 - Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer Phase 1
Active, not recruiting NCT05658003 - A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate Cancer Phase 2
Active, not recruiting NCT05670106 - A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive mCRPC Phase 2
Recruiting NCT04691804 - A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer Phase 3
Completed NCT03896984 - Descriptive Analysis of Clinical Outcomes in Patients With Prostate Gland Cancer, Which Spreads to Other Parts of the Body, Who Were Treated First With Novel Anti-hormone Therapy Followed by a Second Line Treatment With Novel Anti-Hormone Therapy or RadIum-223 (Xofigo).
Recruiting NCT06334432 - Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors Phase 1/Phase 2
Completed NCT03074032 - Safety, Tolerability and Pharmacokinetics of ONC1-0013B in Patients With Progressive Metastatic Castration-resistant Prostate Cancer Phase 1
Recruiting NCT05032040 - A Study of XmAb20717 (Vudalimab)in Patients With Selected Advanced Gynecologic and Genitourinary Malignancies Phase 2
Completed NCT03071328 - INJECT: A Pilot Study of Intra-tumoral Injections in Metastatic Urological Cancers Early Phase 1
Active, not recruiting NCT02649790 - Study of the Safety, Tolerability and Efficacy of KPT-8602 in Participants With Relapsed/Refractory Cancer Indications Phase 1/Phase 2
Completed NCT03030885 - Use of an Experimental Radiopharmaceutical (131I-MIP-1095) in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Phase 1
Terminated NCT03712930 - Treatment of Metastatic Castration-Resistant Prostate Cancer With Homologous Recombination Deficiency Phase 2
Recruiting NCT06241846 - A Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With mCRPC Phase 2
Recruiting NCT03903835 - ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer Phase 3