Palbociclib in Patients With Metastatic Castration-Resistant Prostate Cancer

  • End date
    May 31, 2022
  • participants needed
  • sponsor
    Canadian Cancer Trials Group
Updated on 18 April 2021
endocrine therapy
neutrophil count
hormone therapy
antiandrogen therapy
bone scan
luteinizing hormone-releasing hormone agonist
external beam radiation therapy
castration-resistant prostate cancer
medical castration
adenocarcinoma of prostate
metastatic castration-resistant prostate cancer


The purpose of this study is to find out what effects a new drug, palbociclib, has on prostate cancer and will look at the side effects of treatment with palbociclib. The researchers doing this study are also interested in looking for markers that may help predict which patients are most likely to be helped by palbociclib and to see how the cancer cells respond to palbociclib.


The standard or usual treatment for this disease may be chemotherapy or other types of treatment to slow the spread of the disease and relieve some symptoms of cancer.

Palbociclib is a new type of drug for prostate cancer. Laboratory tests show that it may help slow the growth of prostate cancer. Palbociclib has been shown to help patients with breast cancer but it is not known if the drug is useful for treating prostate cancer.

Condition Malignant neoplasm of prostate, Prostatic disorder, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, prostate carcinoma, prostate cancers
Treatment Palbociclib
Clinical Study IdentifierNCT02905318
SponsorCanadian Cancer Trials Group
Last Modified on18 April 2021


Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have any of these conditions: Prostate Cancer or Prostate Disorders or Prostatic disorder or Prostate Cancer, Early, Recurrent or Malignant neoplasm of prostate?
Do you have any of these conditions: Prostate Cancer, Early, Recurrent or Prostate Cancer or Malignant neoplasm of prostate or Prostate Disorders or prostate cancers or prostate carcinoma...?
Do you have any of these conditions: Prostate Cancer, Early, Recurrent or Malignant neoplasm of prostate or Prostate Cancer or Prostate Disorders or Prostatic disorder or prostate carcino...?
Do you have any of these conditions: Prostatic disorder or Prostate Cancer or Prostate Disorders or Malignant neoplasm of prostate or prostate cancers or prostate carcinoma or Prostate Ca...?
Do you have any of these conditions: prostate cancers or Malignant neoplasm of prostate or Prostate Cancer, Early, Recurrent or Prostatic disorder or prostate carcinoma or Prostate Cancer...?
Do you have any of these conditions: prostate cancers or Prostate Cancer, Early, Recurrent or Prostate Disorders or Malignant neoplasm of prostate or Prostatic disorder or Prostate Cancer...?
Do you have any of these conditions: Prostatic disorder or Prostate Cancer, Early, Recurrent or Prostate Disorders or prostate cancers or prostate carcinoma or Malignant neoplasm of prost...?
Patients must have histologically confirmed adenocarcinoma of the prostate without evidence of small cell/neuroendocrine differentiation
Patients must consent to blood collection for testing prior to enrollment by a central reference laboratory. Screening will be done through the CRPC Master Screening Protocol (IND234)
Patients must have clinically and/or radiologically documented disease. Patients with elevated PSA only are not eligible. All radiology studies must be performed within 28 days prior to enrollment (within 35 days if negative)
All patients must have consented to the release of a tumour block from their primary or metastatic tumour. The centre/pathologist must have agreed to the submission of the specimen
Patients must have evidence of either biochemical or radiological disease progression in the setting of surgical or medical castration
PSA progression
Minimum of two rising PSA values from a baseline measurement with an interval of 1 week between each measurement
PSA must be 2.0 ug/L
Objective progression
RECIST 1.1 or
Soft tissue or visceral disease progression or
PCWG3 for bone progression (>2 new lesions on bone scan or CT)
Surgical/medical castration
Prior orchiectomy or
LHRH agonist/antagonist and testosterone < 50 ng/dL or < 1.7 nmol/L. LHRH agonist/antagonist therapy must be maintained for the duration of study therapy and if previously discontinued, must be restarted and castrate level of testosterone present
Patients must be 18 years of age
ECOG performance status 0 or 1 (Appendix I) and have a life expectancy of 6 months
Previous Therapy
Patients must have recovered from any treatment-related toxicities prior to
registration (unless grade 1, irreversible, or considered by investigator as
not clinically significant)
Prior major surgery is permitted provided that a minimum of 14 days have
elapsed between any major surgery and enrollment (7 days for minor surgery
e.g. port insertion), and that wound healing has occurred
Prior external beam radiation or radium-223 is permitted provided a minimum of
days (4 weeks) have elapsed between the last dose and enrollment. Limited
field radiation (for example less than 25% of marrow bearing bones) for
palliation of bone pain is permitted < 2 weeks prior to starting study drug
Concurrent radiation is not permitted. Prior strontium-89 at any time is not
Systemic Therapy
Prior systemic therapy is permitted as outlined below. Patients must have
recovered from all reversible toxicity related to prior systemic therapy and
have adequate washout prior to enrollmentas follows and as specified in the
Sections below
Longest of one of the following
Two weeks
The longer of 30 days or 5 half-lives for investigational agents
Standard cycle length of standard therapies
Hormonal Therapy: Patients must have received prior hormonal treatment with at
least one of abiraterone acetate, enzalutamide, ARN-509 TAK-700 and TOK-001
Prior anti-androgen therapy must have been discontinued at least 28 days (or
days for bicalutamide) prior to enrollment
Cytotoxic Therapy: Patients may have received docetaxel therapy in the
castrate sensitive setting as well as up to 1 regimen of any cytotoxic therapy
in the CRPC setting. Prior treatment with docetaxel, cabazitaxel and
mitoxantrone is permitted
Immunotherapy: Patients may have received prior immune checkpoint inhibitors
(anti PDL1 and anti CTL-4); vaccines and treatment with oncolytic viruses is
Other therapy
Previous therapy with CDK or mTOR inhibitors is not allowed
Prior treatment with other agents, such as tyrosine kinase or other targeted agents is permissible
Systemic corticosteroids are permitted at a dose equivalent to <10 mg prednisone daily; topical applications (e.g. rash), inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intra-articular) are permitted
Bisphosphonates / denosumab are permitted for treatment of hypercalcemia, osteoporosis and skeletal-related events
Laboratory Requirements (within 7 days of enrollment)
Neutrophils 1.5 x 10^9/L Platelets 100 x 10^9/L Hemoglobin 100 g/L Bilirubin
5 x ULN; if confirmed Gilbert's then bilirubin 3.0 x ULN AST and ALT 1.5 x
ULN; if patient has liver metastases 5.0 x ULN Serum creatinine 1.5 x ULN or
Creatinine clearance 50 mL/min
Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements
Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre
In accordance with CCTG policy, protocol treatment is to begin within 2 working days of patient enrollment
Men of childbearing potential must have agreed to use a highly effective contraceptive method during treatment and for 90 days after stopping treatment and should not father a child or donate sperm during this period

Exclusion Criteria

Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumours curatively treated with no evidence of disease for 5 years
Patients with central nervous system (CNS) involvement unless at least 4 weeks from prior therapy completion (including radiation and/or surgery) AND clinically stable and not receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases
Patients with serious illnesses or medical conditions which could cause unacceptable safety risks or would not permit the patient to be managed according to the protocol. This includes but is not limited to
active infection requiring systemic therapy
uncontrolled/severe cardiovascular disease
active or known human immunodeficiency virus (HIV)
Patients who are unable to swallow oral medication and/or have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
Patients with history of hypersensitivity to palbociclib or any of its excipients
Patients who have been treated with prior CDK4/6 inhibitors, mTOR inhibitors or strontium-89 at any time or require continued or concurrent treatment with
Systemic corticosteroids at a dose equivalent to prednisone > 10 mg daily. Topical applications (e.g. rash), inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intra-articular) are allowed
Any medications or substances that are potent/strong inhibitors or inducers of CYP3A isoenzymes. All patients must have discontinued these medications at least 7 days prior to the first dose of protocol treatment (at least 14 days for herbal/dietary supplements and traditional Chinese medicines)
Bisphosphonates / denosumab for reasons other than hypercalcemia, osteoporosis or skeletal-related events
Warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), factor X inhibitors or fondaparinux is allowed
Other anti-cancer or investigational agents (except LHRH)
Patients with a history of non-compliance to medical regimens
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