Prostate Cancer S1216

April 11, 2017

Sponsor: Southwest Oncology Group

Number: S1216

Eligible patients who enroll in the study will be randomly assigned (by chance) to this phase III trial (Phase III trials, the drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment  to be used safely). This trial studies androgen deprivation therapy and Orteronel to see how well it works compared to androgen deprivation therapy and Bicalutamide, in treating patients with newly diagnosed prostate cancer that has spread to other places in the body. Androgen deprivation therapy (antihormone therapy) suppresses or blocks the production or action of male hormones. Androgens (such as testosterone) can cause the growth of prostate cancer cells. Drugs, such as Orteronel and Bicalutamide, may lessen the amount of androgens made by the body. It is not yet known whether giving androgen deprivation therapy with orteronel or bicalutamide is more effective in treating prostate cancer.

Who’s eligible:

• There are two patient populations eligible for the study:

1. Those who have not started any therapy with LHRH agonist/antagonist, or orchiectomy (Early Induction Group). LHRH are a type of hormone therapy treatment.
2. Those who have already started therapy with LHRH agonist/antagonist, or orchiectomy within the 30 days prior to registration (Late Induction Group). Patients must be registered within 30 days of first injection of the LHRH agonist/ antagonist, or orchiectomy.

Disease Related Criteria:

• All patients must have a histologically (tissue microscopically examined) or cytologically (fluid cells microscopically examined) proven diagnosis of adenocarcinoma of the prostate. All patients must have metastatic disease (the development of secondary malignant growths at a distance from a primary site of cancer) as evidenced by soft tissue and/or bony metastases prior to initiation of androgen deprivation therapy (antihormone therapy).
• The early induction group patients who have not yet started androgen deprivation therapy (LHRH agonist/antagonist or orchiectomy) and will not have an LHRH agonist injection until after randomization (early induction group) must have radiographic assessments of all disease. Assessments including bone scan (or positron emission tomography [PET] scan) within 42 days prior to registration.
• The late induction group patients who have started androgen deprivation therapy (LHRH agonist/antagonist or orchiectomy) prior to registration . must have radiographic assessments including bone scan (or PET scan) within 42 days prior to start of androgen deprivation therapy. If scans have not been obtained prior to LHRH agonist/antagonist or orchiectomy they must be done within 42 days prior to registration). All disease assessments must be documented on the Baseline Tumor Assessment Form (NOTE: Androgen deprivation therapy does not include treatment with anti-androgens such as Bicalutamide or Flutamide or five alpha reductase inhibitors such as Finasteride or Dutasteride).
• This study is for male patients age 18 and older.

Available at: Backus Hospital- Eastern Connecticut Hematology and Oncology.