Pacritinib for Biochemical Relapse After Definitive Treatment for Prostate Cancer (BLAST)
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|ClinicalTrials.gov Identifier: NCT04635059|
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : July 20, 2022
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Pacritinib||Phase 2|
This phase 2, single-arm, open-label study using pacritinib will treat patients with histologically confirmed prostate adenocarcinoma, status post definitive treatment and biochemical recurrence.
The primary objective of this study is to determine the effect of pacritinib on the time to prostate-specific antigen (PSA) progression in patients with biochemical relapse of prostate cancer (defined as the length of time that a given subject will be alive and free from PSA progression per Prostate Cancer Working Group 3 (PCWG3) guidelines.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pacritinib for Biochemical Relapse After Definitive Treatment for Prostate Cancer|
|Actual Study Start Date :||June 1, 2021|
|Estimated Primary Completion Date :||June 1, 2025|
|Estimated Study Completion Date :||June 1, 2026|
Pacritinib is an oral drug.
Pacritinib is an oral drug which will be taken daily on a 28-day cycle at a dose of 200 mg twice a day (BID).
Other Name: SB1518
- The number of patients with six-month PSA progression-free survival. [ Time Frame: 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.
- PSA Levels [ Time Frame: 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 [ Time Frame: Baseline and four months ]Serum testosterone will be measured in nanograms per deciliter.
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): NCT04635059
|Contact: Medical College of Wisconsin Cancer Center Clinical Trials Officeemail@example.com|
|United States, Wisconsin|
|Froedtert & the Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Deepak Kilari, MD 414-805-4600 firstname.lastname@example.org|
|Principal Investigator:||Deepak Kilari, MD||Medical College of Wisconsin|