A Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT02059213|
Recruitment Status : Completed
First Posted : February 11, 2014
Results First Posted : January 28, 2019
Last Update Posted : September 16, 2020
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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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Ibrance Drug: Bicalutamide Drug: Zoladex Drug: Lupron Depot||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Hormone-Sensitive Prostate Cancer|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||September 9, 2017|
|Actual Study Completion Date :||June 4, 2019|
Active Comparator: ADT Alone
Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
Other Name: Casodex
Other Name: Goserelin acetate implant
Drug: Lupron Depot
Other Name: Leuprolide
Experimental: ADT + Ibrance®
Ibrance® (125mg taken daily by mouth days 1-21 of a 28 day cycle) in addition to Androgen Deprivation Therapy (ADT): Bicalutamide (an active non-steroidal antiandrogen; 50mg taken daily by mouth) and Zoladex (LHRH agonist administered by injection), or Lupron Depot (LHRH agonist, administered by injection).
Other Name: Casodex
Other Name: Goserelin acetate implant
Drug: Lupron Depot
Other Name: Leuprolide
- Number of Patients Who Achieve a PSA ≤ 4ng/mL After Seven Months of Protocol Treatment in Each Arm [ Time Frame: 28 weeks ]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.
- Number of Participants With Grade >=3 Adverse Events That Are Possibly, Probably or Definitely Related to Study Treatment [ Time Frame: Up to 54 months ]Grade >=3 adverse events that are possibly, probably or definitely related to study treatment, reported by number of participants affected in each arm
- Duration of Therapy [ Time Frame: Up to 54 months ]Duration of therapy will be reported to describe tolerability within each arm.
- Proportion of Patients Who Achieve Undetectable PSA (<0.2ng/mL) [ Time Frame: Up to 54 months ]
- Biochemical Progression-free Survival Rate [ Time Frame: Up to 54 months ]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.
- Clinical Progression-free Survival Rate [ Time Frame: Up to 54 months ]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.
- Frequency of Dose Modification [ Time Frame: Up to 54 months ]Dose modifications will be reported to describe tolerability for arm 2 only (Ibrance®)
- Frequency of Treatment Delay [ Time Frame: Up to 54 months ]Treatment delays will be reported to describe tolerability within each arm.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- Have pathologic diagnosis of prostate cancer.
- Have hormone-sensitive metastatic disease (M1) as evidenced by soft tissue and/or bony metastases.
- Patients may either be untreated for their newly diagnosed metastatic disease (preferred as much as possible) or have started androgen deprivation therapy. Patients who have started androgen deprivation therapy for the treatment of their newly diagnosed metastatic disease are eligible as long as the duration of treatment is less than or equal to 2 weeks (14days) prior to registration. The start date of androgen deprivation is considered the day the patient first received an injection of a LHRH agonist/antagonist (or orchiectomy), not the date when an oral antiandrogen started.
- Patients must have a minimum PSA (Prostate-Specific Antigen) ≥ 5 ng/mL within 60 days of registration or prior to the initiation of androgen deprivation for patients who have started androgen deprivation therapy.
- Agree to undergo a biopsy of at least one metastatic site for RB (Retinoblastoma Protein) status evaluation. Adequate metastatic tissue from prior biopsy/resection can be used if available in lieu of a biopsy.
- ECOG performance status of 0-2 (Eastern Cooperative Oncology Group scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 5 where 0 represents perfect health and 5 represents death).
- Patients may have received prior neoadjuvant and/or adjuvant hormonal therapy, for non-metastatic disease but it must not have lasted for more than 36 months. At least 12 months must have elapsed since completion of androgen deprivation therapy in the neoadjuvant and/or adjuvant setting.
- Within 14 days prior to registration patients must have adequate organ and marrow function: White Blood Cell (WBC) count ≥ 3,000/μl, Absolute Neutrophil Count (ANC) ≥ 1,500/μl, Platelet Count ≥ 100,000/μl, Serum Creatinine ≥1.5 x the institutional upper limits of normal or corrected creatinine clearance of ≥ 50 mg/ml/hr/1.73 m2 BSA (Body Surface Area), Bilirubin within the institutional limits of normal, AST (Aspartate Aminotransferase) ≤ 2 x upper limits of normal, ALT (Alanine Aminotransferase) ≤ 2 x upper limits of normal.
- Patients must be able to take oral medication without crushing, dissolving or chewing tablets.
- Patients may have received prior radiation therapy or surgery. However, at least 14 days must have elapsed since completion of radiation therapy or surgery and patient must have only grade 2 or less adverse effects at the time of registration.
- Patients must agree to use highly effective contraception during treatment and for a period of 90 days after ending treatment with PD 0332991.
- Ability to understand and the willingness to sign a written informed consent document that is approved by an institutional review board.
- Patients who have received androgen deprivation therapy for greater than 14 days (LHRH-agonist or antagonist) for the treatment of their newly diagnosed metastatic disease prior to enrollment are not eligible for this study.
- Patients who are currently being treated with strong CYP3A4 inhibitors (e.g., amprenavir, fosamprenavir, indinavir, itraconazole, ketoconazole, lopinavir, mibefradil, miconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, verapamil, voriconazole, and grapefruit) or strong inducers (e.g., carbamazepine, felbamate, nevirapine, phenobarbital, phenytoin, primidone, rifabutin, rifampin, rifapentine and St. John's wort) must either discontinue these drugs or are ineligible.
- Patients must refrain from the use of proton pump inhibitors. If needed, alternative antacid therapies may be used including H2-receptor antagonists, and locally acting antacids.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III and IV heart failure), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not eligible. Patients are not considered to have a "currently active" malignancy if they have completed all therapy and are now considered without evidence of disease for 1 year.
- HIV-positive patients on combination antiretroviral therapy are ineligible .
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059213
|United States, California|
|City of Hope Cancer Center|
|Duarte, California, United States, 91010|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231|
|United States, Michigan|
|University of Michigan Hospital|
|Ann Arbor, Michigan, United States, 48109|
|United States, Missouri|
|Washington University in St. Louis|
|Saint Louis, Missouri, United States, 63110|
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|United States, Utah|
|Huntsman Cancer Institute, University of Utah|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Maha Hussain, MD, FACP, FASCO||University of Michigan Comprehensive Cancer Center and Northwestern University|
Documents provided by University of Michigan Rogel Cancer Center:
|Responsible Party:||University of Michigan Rogel Cancer Center|
|Other Study ID Numbers:||
HUM00082715 ( Other Identifier: University of Michigan )
|First Posted:||February 11, 2014 Key Record Dates|
|Results First Posted:||January 28, 2019|
|Last Update Posted:||September 16, 2020|
|Last Verified:||August 2020|
Genital Neoplasms, Male
Neoplasms by Site
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action
Fertility Agents, Female
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Hormones, Hormone Substitutes, and Hormone Antagonists