CLINICAL TRIAL

Pacritinib for Prostate Cancer

Recruiting · 18+ · Male · Milwaukee, WI

This study is evaluating whether a drug called pacritinib may help reduce the risk of prostate cancer recurrence.

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About the trial for Prostate Cancer

Eligible Conditions
Prostate Cancer · Prostatic Neoplasms

Treatment Groups

This trial involves 2 different treatments. Pacritinib 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Pacritinib
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pacritinib
Not yet FDA approved

Eligibility

This trial is for male patients aged 18 and older. You must have received 1 prior treatment for Prostate Cancer or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Prior adjuvant or salvage radiation or not a candidate for radiation based upon clinical assessment of disease characteristics and patient comorbidities. (N/A for patients who underwent definitive radiation therapy).
Eastern Cooperative Oncology Group (ECOG) Performance Status grade 0 or 1 or Karnofsky Performance Status ≥ 70.
No prior Janus Kinase 2 (JAK2) inhibitor treatment.
Patients aged ≥ 18 years.
Prior radical prostatectomy or definitive radiation.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Screening, every month for six months, then every two months until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Screening, every month for six months, then every two months until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Pacritinib will improve 1 primary outcome and 2 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of Screening, every month for six months, then every two months until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months..

PSA Levels
SCREENING, EVERY MONTH FOR SIX MONTHS, THEN EVERY TWO MONTHS UNTIL THE DATE OF FIRST DOCUMENTED PROGRESSION OR DATE OF DEATH FROM ANY CAUSE, WHICHEVER CAME FIRST, ASSESSED UP TO 48 MONTHS.
PSA level in blood is measured in units of nanograms per milliliter.
Testosterone Measurement
BASELINE AND FOUR MONTHS
Serum testosterone will be measured in nanograms per deciliter.
The number of patients with six-month PSA progression-free survival.
SIX MONTHS
PSA progression-free survival is defined as the length of time that a subject will be alive and free from PSA progression per PCWG3 guidelines.

Who is running the study

Principal Investigator
D. K.
Prof. Deepak Kilari, Associate Professor
Medical College of Wisconsin

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 are common treatments for prostate cancer?

Different treatment strategies are used to treat and manage prostate cancer, and in some cases these differ considerably between geographic regions and countries. It may be difficult to find reliable information on common treatments on the internet. This article will review different common treatments for prostate cancer.

Anonymous Patient Answer

What causes prostate cancer?

The causes of PCa remain a mystery, but certain things such as increased male hormones and increased dietary intake of fats, sugar, and cholesterol are linked to the development of the disease. Prostate cancer has also been associated with a person's physical health and lifestyle.\n

Anonymous Patient Answer

Can prostate cancer be cured?

Most patients with clinically localized [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) that undergo radical prostatectomy with pelvic lymphadenectomy will continue to live for 30 years after surgery and the prostate cancer will either recur. Therefore, despite advances in surgery since the early 1990s, radical prostatectomy plus androgen blockade remains the curative therapy of choice for localized prostate cancer. However, the prognosis for patients with the disease at intermediate to advanced stages may be improved with more precise treatment approaches that include prostate specific antigen, multiparametric imaging and magnetic resonance imaging.

Anonymous Patient Answer

What is prostate cancer?

It was defined in 1897 via a Danish autopsy in Rigshospitalet in Copenhagen by an eminent Danish pathologist Niels Christian Hansen. He found in the rectum a "prostate like mass" he called "polypoid tumor". In Copenhagen during the 19th century the word “prostate” was an obsolete word denoting a part of the body, and “polypoid” referred to an enlargement of a normal organ or tissue.

Anonymous Patient Answer

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

A total of 703,950 people are diagnosed with PC in the Unites states each year. About 18.3% of all men diagnosed with PC have prostate cancer at diagnosis.

Anonymous Patient Answer

What are the signs of prostate cancer?

Some signs of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) include frequent, painful, or bloody urination, or an inconsistent stream during urination. Sudden onset of erectile disfunction is also a sign of prostate cancer. A biopsy done for suspected cancer often discloses prostate cancer.

Anonymous Patient Answer

Have there been other clinical trials involving pacritinib?

Pacritinib is a novel small molecule pan-HER inhibitor being developed by Novartis as the first in its class of dual pan-HER and anti-angiogenesis inhibitors, for use in patients with selected types of cancer. It is actively enrolled in an open-label, phase II trial in women with hormone-receptor-positive lung metastatic breast cancer. This trial was developed in response to a recent unexpected unexpected toxicity profile with the first-in-class pan-HER inhibitor, afatinib. Afatinib does not appear to be associated with the same adverse events or serious toxicities seen with pacritinib.

Anonymous Patient Answer

How does pacritinib work?

In the same way in which the G719S mutation of EGF is the primary cause for the growth of a subset of non-small cell lung cancer patients, we can propose that the T790M mutation of EGFR is responsible for the resistance of a significant number of non-small cell lung cancer patients to EGFR tyrosine kinase inhibitors, such as gefitinib. In a majority of cases, this resistance evolves following mutations of A749 and L769 within the T790M gatekeeper area, resulting in the stabilization of the kinase domain and therefore to maintain the activation of downstream pathway.

Anonymous Patient Answer

What does pacritinib usually treat?

Pacritinib shows broad efficacy in metastatic HR-positive lung adenocarcinoma with a specific molecular profile. Findings from a recent study strongly suggests the clinical benefit associated with the PIK3CA inhibitor pacritinib in [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer). Findings from a recent study should assist clinicians and decision makers in their selection of treatment for lung cancer. Clin Cancer Res; 21(15); 3217-28. ©2015 AACR.

Anonymous Patient Answer

What is the average age someone gets prostate cancer?

Prostate cancer is the third most common cancer among men aged 40-69 years. Prostate-specific antigen is a highly sensitive PSA blood test-specific for [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer). It is recommended that the PSA test be used routinely for prostate cancer because it will improve detection rates for early cases and prevent overdiagnosis for men ages 40-69 who have not previously received PSA-based cancer screenings. Other factors that decrease prostate cancer incidence in the United States.

Anonymous Patient Answer

What is pacritinib?

Pacritinib is an orphan drug for people with ALK-positive metastatic non-small cell lung cancer (NSCLC). Pacritinib is being developed by Pfizer Inc. This development is not limited to ALK-positive metastatic NSCLC, but aims to support the concept of treating patients with tumors which are positive for the same gene, ALK. ALK-positive metastatic NSCLC is a biologically distinct type of lung cancer with distinctive genetic and genomic profiles compared with other types of NSCLC. ALK-positive metastatic NSCLC is a patient with high, potentially treatable, mutation rates in the EGFR and its downstream pathway.

Anonymous Patient Answer
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