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Prostate CancerPhase 2NCT02905318

Palbociclib in Patients With Metastatic Castration-Resistant Prostate Cancer

A Phase 2 study testing Palbociclib in people with Prostate Cancer, run by Canadian Cancer Trials Group at 7 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Palbociclib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
7 sitesCanada
Study dates
4 Jul 2017to 30 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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).
  • Surgery:
  • 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.
  • Radiation:
  • Prior external beam radiation or radium-223 is permitted provided a minimum of 28 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 permitted.
  • 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 42 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 permissible.
  • 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 ≤ 1.5 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.

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Canada7 sites

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • London Regional Cancer Program

    London, Ontario, N6A 5W9

  • CHUM-Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

  • University Health Network

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase II Study of Palbociclib, A CDK4/6 Inhibitor, in Patients With 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.

Read the detailed description

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.

Conditions
Prostate Cancer
Being tested
Palbociclib
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PalbociclibDrug

    125 mg orally on days 1-21 each 28 day cycle

Study groups in NCT02905318
Study groupRoleWhat they receive
PalbociclibExperimental125mg orally days 1-21 every 28 day cycle
Receives: Drug: Palbociclib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical benefit rate estimated by proportion of evaluable patients who had CR, PR or SD as their best response to treatment

    Clinical benefit is defined as one of the following:

    • PSA decline ≥ 50%
    • CR or PR (objective)
    • SD for ≥12 weeks (objective, without PSA progression)

    Measured: 36 months

Secondary outcomes (5)

  1. Effect of Palbociclib on PSA decline based on decrease in PSA test values from the baseline value

    Measured: 36 months

  2. Objective response determined by RECIST 1.1

    Measured: 36 months

  3. Progression-free survival

    Measured: 36 months

  4. Overall survival

    Measured: 36 months

  5. Number and severity of adverse events

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2016 (estimated)
  2. Study start4 Jul 2017
  3. Primary completion29 Apr 2022
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02905318
Sponsor's protocol ID
I223
Status last verified
Mar 2026
First submitted
8 Sep 2016
Last updated
9 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Palbociclib in people with Prostate Cancer, run by Canadian Cancer Trials Group at 7 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 43 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical benefit rate estimated by proportion of evaluable patients who had CR, PR or SD as their best response to treatment (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02905318.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.

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