This study will look at the effect of adding the drug Palbociclib to CAD (Combined Androgen Deprivation) therapy in patients with RB (Retinoblastoma Protein) positive hormone sensitive prostate cancer. The investigators hypothesize that the addition of Palbociclib to initial ADT (Androgen Deprivation Therapy) in patients with newly metastatic RB-positive prostate cancer may significantly increase the efficacy of ADT.
Patients will undergo exams, tests, and procedures to determine if they are eligible to participate. Subjects will be randomized to one of two groups. Patients randomized to Arm 1 - Patients will receive the LHRH agonist every 3 months. Patients will also take 50 mg. of bicalutamide by mouth every day. Bicalutamide comes in tablet form. This arm is broken down into periods of time called cycles, starting with cycle 1 then cycle 2, and so on.Each cycle is 28 days long. If randomized to Arm 2 - Patients will receive the LHRH agonist every 3 months. Patients will also take 50 mg. of bicalutamide by mouth every day. Patients will also take 125 mg. of Ibrance® daily for 21 days, and then will stop taking Ibrance® for 7 days. Patients will then begin taking Ibrance® again after 7 days off. Patients will keep repeating this cycle every 28 days. When the patient starts the first 28 day cycle that will be cycle 1, then cycle 2, and so on. During each cycle the patient will come in for routine and research tests and procedures for patient safety, to see how patients are doing, and for research purposes. The researchers will ask patients to complete a drug diary to track bicalutamide and Ibrance® administration. The total time of study participation depends on how a patient responds to the study medications. Patients may be on the study for a short period of time, such as a week, or for a longer period of time, such as a few years. Patients may continue on study treatment until one of the following: cancer progresses (gets worse); another illness or condition develops that prevents study participation; unacceptable side effects occur; drug is delayed more than 4 weeks; patient withdraws consent; the study doctor thinks the patient should stop; the patient does not follow researcher's instructions; the study is cancelled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
City of Hope Cancer Center
Duarte, California, United States
Northwestern University
Chicago, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
University of Michigan Hospital
Number of Patients Who Achieve a PSA ≤ 4ng/mL After Seven Months of Protocol Treatment in Each Arm
The primary analysis will be assessment of the proportion of patients who achieve a (Prostate-specific antigen) PSA \< 4ng/mL after seven months of protocol treatment in each arm.
Time frame: 28 weeks
Number of Participants With Grade >=3 Adverse Events That Are Possibly, Probably or Definitely Related to Study Treatment
Grade \>=3 adverse events that are possibly, probably or definitely related to study treatment, reported by number of participants affected in each arm
Time frame: Up to 54 months
Duration of Therapy
Duration of therapy will be reported to describe tolerability within each arm.
Time frame: Up to 54 months
Proportion of Patients Who Achieve Undetectable PSA (<0.2ng/mL)
Time frame: Up to 54 months
Biochemical Progression-free Survival Rate
12-month biochemical progression-free survival rate will begin from treatment start until the event of biochemical (PSA) progression or death, whichever occurs first. Described by arm using Kaplan-Meier methods.
Time frame: Up to 54 months
Clinical Progression-free Survival Rate
12-month clinical progression-free survival rate will begin from treatment start until the event of biochemical (PSA) progression or death, whichever occurs first. Described by arm using Kaplan-Meier methods.
Time frame: Up to 54 months
Frequency of Dose Modification
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Masking
NONE
Enrollment
72
Ann Arbor, Michigan, United States
Washington University in St. Louis
St Louis, Missouri, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
Dose modifications will be reported to describe tolerability for arm 2 only (Ibrance®)
Time frame: Up to 54 months
Frequency of Treatment Delay
Treatment delays will be reported to describe tolerability within each arm.
Time frame: Up to 54 months