Palbociclib for Prostate Cancer

1
Effectiveness
2
Safety
Allan Blair Cancer Centre, Regina, Canada
Prostate Cancer+1 More
Palbociclib - Drug
Eligibility
18+
Male
Eligible conditions
Prostate Cancer

Study Summary

This study is evaluating whether a new drug, palbociclib, has effects on prostate cancer and will look at the side effects of treatment with palbociclib.

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Eligible Conditions

  • Prostate Cancer
  • Prostatic Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Palbociclib will improve 1 primary outcome and 5 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of 36 months.

36 months
Clinical benefit rate estimated by proportion of evaluable patients who had CR, PR or SD as their best response to treatment
Effect of Palbociclib on PSA decline based on decrease in PSA test values from the baseline value
Number and severity of adverse events
Objective response determined by RECIST 1.1
Overall survival
Progression-free survival

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Side Effects for

Palbociclib With Adjuvant Endocrine Therapy
Neutrophil count decreased
48%
Fatigue
36%
Anemia
26%
Edema limbs
6%
Palpitations
4%
Blood and lymphatic system disorders - Other, specify
2%
Tinnitus
2%
Chills
2%
Pain
2%
Localized edema
1%
Bronchial infection
1%
Alopecia
1%
Dyspepsia
1%
Vestibular disorder
1%
Ear and labyrinth disorders - Other, specify
1%
Dry skin
1%
Nausea
1%
Diarrhea
1%
Cardiac disorders - Other, specify
1%
Lymphocyte count decreased
1%
Mucositis oral
1%
Breast infection
1%
Soft tissue infection
1%
Hypertension
1%
Lymph node pain
1%
Chest pain - cardiac
1%
Sinus bradycardia
1%
Non-cardiac chest pain
1%
Vertigo
1%
Sinus tachycardia
1%
Ear pain
1%
Pain of skin
1%
Fever
1%
Flu like symptoms
1%
Skin infection
1%
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT02040857) in the Palbociclib With Adjuvant Endocrine Therapy ARM group. Side effects include: Neutrophil count decreased with 48%, Fatigue with 36%, Anemia with 26%, Edema limbs with 6%, Palpitations with 4%.

Trial Design

2 Treatment Groups

Control
Palbociclib

This trial requires 19 total participants across 2 different treatment groups

This trial involves 2 different treatments. Palbociclib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Palbociclib
Drug
125mg orally days 1-21 every 28 day cycle
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 36 months for reporting.

Closest Location

Allan Blair Cancer Centre - Regina, Canada

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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).
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.
ECOG performance status 0 or 1 (Appendix I) and have a life expectancy of ≥ 6 months.
Patients must have histologically confirmed adenocarcinoma of the prostate without evidence of small cell/neuroendocrine differentiation.
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.
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
RECIST 1.1 or Soft tissue or visceral disease progression or PCWG3 for bone progression (>2 new lesions on bone scan or CT)
Patients must be ≥18 years of age.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes prostate cancer?

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There is little evidence for viruses or bacteria to cause prostate cancer. Tobacco smoking is the strongest known lifestyle risk factor for the disease. However, there is some evidence that prostate cancer may be prevented by having regular exercise, reducing alcohol consumption, and avoiding diethylene glycol in antifreeze. It may be caused by prostatic inflammation.\n

Unverified Answer

What are common treatments for prostate cancer?

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The treatments for prostate cancer and treatment effects on the symptoms of fatigue and body pain are limited. Many strategies to maximize survival have been introduced and still further research has to be conducted.

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What is prostate cancer?

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In the United States, [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is the most frequently diagnosed cancer in men of 65 or older (2010) and the second most common after lung cancer (2005). This disease was more common among blacks (1994-1999). Prostate cancer was also less common before 1974, when the first case was reported. In the US prostate cancer has a 2-fold improvement from 1973 to 1992 in terms of detection. The prognosis is excellent and treatment is very effective when compared to other cancers. Although prostate cancer has been described in horses, it rarely causes death. However, many men are affected by the condition and some, perhaps as many as a fifth, develop benign prostate hyperplasia or prostatitis.

Unverified Answer

What are the signs of prostate cancer?

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This is the first Australian, national study to show increased mortality in men who had prostate cancer diagnosed in a recent time frame, compared to one in ten who survived until the age of 75. This difference may indicate a need for earlier detection of prostate cancer and better screening of high risk men from a younger age and earlier diagnosis.

Unverified Answer

Can prostate cancer be cured?

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Patient and family support can help men understand the implications of test results and promote proactive care. Most men prefer less aggressive form of treatment after receiving results.

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How many people get prostate cancer a year in the United States?

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This estimate of prostate cancer cases per year in the US was calculated from case reports in a variety of settings. The data supporting this analysis are uncertain and have to be considered for general implementation. The estimates given in this paper should not be used for public policy purposes or as a basis for a health care decision in the case of diagnosis of prostate cancer, but should be considered for epidemiological and market analysis purposes.

Unverified Answer

Is palbociclib typically used in combination with any other treatments?

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The combination of palbociclib plus abiraterone or androgen deprivation therapy has been shown to possess superior response rates, progression-free survival, and progression-free survival compared with either agent as monotherapy. The benefit of this combination relative to abiraterone plus androgen deprivation therapy is particularly pronounced for patients with advanced prostate cancer. In accordance with its FDA approval label, this combination is recommended in patients for whom hormonal ablation therapy is considered following a negative transrectal ultrasound. Furthermore, the combination of abiraterone monotherapy and pembrolizumab is superior to both agents as monotherapy. These differences were found in this study even when accounting for stratification at baseline based on age.

Unverified Answer

Does prostate cancer run in families?

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The present data do not support the hypothesis that PSC is an autosomal dominant condition. Furthermore, the present results do not support the concept that PSC is inherited from an unidentified mutation on chromosome 8p11, particularly since no obvious candidate genes for this disease have been identified or implicated thus far.

Unverified Answer

Who should consider clinical trials for prostate cancer?

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Findings from a recent study suggests that there is likely to be a significant proportion of men being denied a potentially curative treatment alternative because of low rates of recruitment. Furthermore, the proportion with acceptable outcomes may be far less than previously reported. As more centers begin to initiate clinical trials in this disease, we expect these results to become a real impediment to undertaking prostate cancer research in the UK.

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How quickly does prostate cancer spread?

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There was no significant relationship between the type of treatment and the rate of metastasis. Patients with Gleason 7 disease appear to have metastasis in roughly equal numbers in both groups, suggesting that the rate of metastatic dissemination is high to begin with.

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What are the common side effects of palbociclib?

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Commonly reported side effects of palbociclib were mostly mild to moderate and the most common were acne, dry skin, back pain, and constipation, which improved in the majority of patients with palbociclib treatment.

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What does palbociclib usually treat?

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P-bx. In contrast to other studies, our data show that nearly all patients would have experienced a PSA reduction ≥30% after one year. The PSA-reduction rates after three or four years were only 10.6%, so that palbociclib is not an effective treatment option in terms of efficacy.

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