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Antiandrogen
Arm A (LHRHa, apalutamide) for Prostate Adenocarcinoma
Phase 2
Waitlist Available
Led By Christopher Logothetis
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening up to 4 weeks post-surgery, an average of 7 months
Awards & highlights
Study Summary
This phase II trial studies how well apalutamide and gonadotropin-releasing hormone analog with or without abiraterone acetate work in treating participants with prostate cancer prior to surgery. Apalutamide and abiraterone acetate may stop the growth of cancer cells either by killing the cells or by blocking some of the enzymes needed for cell growth. Hormone therapy, using gonadotropin-releasing hormone analog, may fight prostate cancer by lowering the amount of testosterone the body makes. Giving apalutamide, gonadotropin-releasing hormone analog, and abiraterone acetate may work better in treating participants with prostate cancer.
Eligible Conditions
- Prostate Adenocarcinoma
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from screening up to 4 weeks post-surgery, an average of 7 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening up to 4 weeks post-surgery, an average of 7 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prostatectomy
Secondary outcome measures
Assessment of Positive Surgical Margins in the Surgical Specimen
Number of Participants With Incidence of Adverse Events
Time to Prostate Specific Antigen Recurrence (TTRPSA)
+1 moreOther outcome measures
Assessment of Protein and Ribonucleic Acid (RNA) Analysis Results
Assessment of Steroid Hormone Metabolome in Blood Plasma and Tissue
Citrate Intracellular Tricarboxylic Acid (TCA) Cycle Metabolite Concentrations
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (LHRHa, apalutamide, abiraterone acetate)Experimental Treatment5 Interventions
Participants receive gonadotropin-releasing hormone analog and apalutamide as in arm A, abiraterone acetate PO QD, and prednisone PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy.
Group II: Arm A (LHRHa, apalutamide)Experimental Treatment3 Interventions
Participants receive gonadotropin-releasing hormone analog (leuprolide, goserelin, or triptorelin as determined by treating physician) IM once every 3 months and apalutamide PO QD. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning no less than 48 hours after completion of therapy, participants undergo radical prostatectomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Luteinizing hormone
FDA approved
Cortisone
Not yet FDA approved
Abiraterone
FDA approved
Apalutamide
FDA approved
Radical Prostatectomy
2005
Completed Phase 2
~4550
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,422 Total Patients Enrolled
Christopher LogothetisPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
344 Total Patients Enrolled
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