Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 45
Summary
- Conditions
- Prostate Adenocarcinoma
- Stage IIB Prostate Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
PRIMARY OBJECTIVE: I. To determine whether 6 months (24 weeks) of neoadjuvant apalutamide prior to prostatectomy for intermediate risk prostate cancer results in a reduction of aggregate pathologic risk features that drive post-operative radiotherapy recommendations from 35% to 15%. SECONDARY OBJECT...
PRIMARY OBJECTIVE: I. To determine whether 6 months (24 weeks) of neoadjuvant apalutamide prior to prostatectomy for intermediate risk prostate cancer results in a reduction of aggregate pathologic risk features that drive post-operative radiotherapy recommendations from 35% to 15%. SECONDARY OBJECTIVES: I. To determine the safety and tolerability of 6 months (24 weeks) neoadjuvant apalutamide followed by radical prostatectomy for intermediate risk prostate cancer. II. To estimate the frequency of clinical complete responses and "near" complete responses (currently defined as < 6 mm total tumor volume). III. To characterize the molecular features of the treated prostate cancers and link them to morphologic characterization. IV. To measure the 3-5 year biochemical recurrence rate of treated patients as a baseline to inform a larger phase III trial. OUTLINE: Patients receive apalutamide orally (PO) daily for 24 weeks in the absence of disease progression or unacceptable toxicity. Within 2 weeks of completing apalutamide, patients undergo radical prostatectomy. After completion of study treatment, patients are followed up at 12 months.
Tracking Information
- NCT #
- NCT03412396
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: John W Davis M.D. Anderson Cancer Center