Apalutamide for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Prostate CancerApalutamide - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is testing if treatment with medications that reduce the male hormone level can shrink prostate cancer and reduce the chances of the cancer coming back. The treatments include a hormone injection and the study drugs, which include abiraterone acetate, prednisone, and apalutamide.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 24 months

10 months from randomization
PSA Response Rate
24 months
Minimal residual disease (MRD)
Pathologic complete response
Time to PSA Progression

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

ADT + Apalutamide + Abiraterone Acetate + Prednisone
1 of 3
ADT + Apalutamide
1 of 3
Apalutamide, SBRT, Radiation
1 of 3

Experimental Treatment

112 Total Participants · 3 Treatment Groups

Primary Treatment: Apalutamide · No Placebo Group · Phase 2

ADT + Apalutamide + Abiraterone Acetate + PrednisoneExperimental Group · 6 Interventions: Radical Prostatectomy, Apalutamide, Abiraterone Acetate, Prednisone, GnRH agonist/antagonist, Extended Pelvic lymphadenectomy · Intervention Types: Procedure, Drug, Drug, Drug, Drug, Procedure
ADT + ApalutamideExperimental Group · 4 Interventions: Radical Prostatectomy, Apalutamide, GnRH agonist/antagonist, Extended Pelvic lymphadenectomy · Intervention Types: Procedure, Drug, Drug, Procedure
Apalutamide, SBRT, RadiationExperimental Group · 2 Interventions: Stereotactic Body Radiation Therapy, Apalutamide · Intervention Types: Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2019
Completed Phase 2
~610
Radical Prostatectomy
2005
Completed Phase 2
~4520
Apalutamide
FDA approved
Abiraterone
FDA approved
Prednisone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,832 Previous Clinical Trials
584,426 Total Patients Enrolled
127 Trials studying Prostate Cancer
65,303 Patients Enrolled for Prostate Cancer
Dana-Farber Cancer InstituteOTHER
1,016 Previous Clinical Trials
393,686 Total Patients Enrolled
67 Trials studying Prostate Cancer
15,999 Patients Enrolled for Prostate Cancer
Howard Scher, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
36 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a male aged 18 years and above.
You have a clinically localized prostate cancer with histologically confirmed adenocarcinoma of the prostate with either ≥3 positive cores or 2 positive cores if >1cm in length with at least 50% tumor content.