A Study of Apalutamide in Participants With High‑Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Overview

About this study

The purpose of this study is to determine if treatment with androgen deprivation therapy (ADT) plus apalutamide before and after radical prostatectomy in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS), as compared to ADT plus placebo.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria: 

  • Histologically confirmed adenocarcinoma of the prostate.
  • Candidate for radical prostatectomy with lymph node dissection as per the investigator.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Contraceptive (birth control) use by men (or female partners of men enrolled in the study who are of childbearing potential or are pregnant) should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies.
  • Able to receive androgen deprivation therapy (ADT) for up to 1 year, per the investigator's assessment.
  • Participants are considered eligible only if the central radiological review confirms clinical stage M0.

Exclusion Criteria: 

  • Distant metastasis (clinical stage M1).
  • Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion.
  • Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review.
  • Prior treatment with antiandrogen.
  • History of pelvic radiation for prostate cancer.
  • Use of any investigational agent ≤ 4 weeks prior to randomization or any therapeutic procedure for prostate cancer at any time.
  • Major surgery ≤ 4 weeks prior to randomization.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Winston Tan, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Winston Tan, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Winston Tan, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20473400

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