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Prostate CancerPhase 2BLASTNCT04635059

Pacritinib for Biochemical Relapse After Definitive Treatment for Prostate Cancer

A Phase 2 study testing Pacritinib in people with Prostate Cancer, run by Medical College of Wisconsin at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a single-arm, open-label study using pacritinib for patients with histologically confirmed prostate adenocarcinoma, status post definitive treatment and biochemical recurrence. 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?
Pacritinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
1 Jun 2021to 27 Oct 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 aged ≥ 18 years.
  • Histologically or cytologically confirmed prostate adenocarcinoma.
  • Prior radical prostatectomy or definitive radiation.
  • Biochemically recurrent prostate cancer with PSA doubling time ≤ 9 months at the time of study entry (calculated per Memorial Sloan Kettering Cancer Center (MSKCC) prostate nomogram: https://www.mskcc.org/nomograms/prostate/psa_doubling_time). Calculation of PSA doubling time should include the use of all available PSA values obtained within the past 12 months prior to randomization, with a minimum of three values separated by at least two weeks apart. The PSA values used to calculate the PSA doubling time must all be ≥ 0.1 ng/mL and should be measured in the same laboratory whenever feasible.
  • 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).
  • Screening PSA > 0.5 ng/mL.
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  • No definitive evidence of metastases on screening computerized tomography scan (CT) or magnetic resonance imaging (MRI) of abdomen/pelvis and radionuclide whole-body bone scan per the judgment of the investigator. Abdominal and/or pelvic lymph nodes measuring 1.5 cm or less in short axis diameter are allowed. Lesions identified on other imaging modalities (e.g. prostate specific membrane antigen (PSMA) or choline positron emission tomography (PET)) that are not visualized on CT and/or MRI or radionuclide bone scan are allowed. Equivocal lesions on bone scan should be followed up with additional imaging as clinically indicated.
  • Screening serum testosterone > 150 ng/dL.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status grade 0 or 1 or Karnofsky Performance Status ≥ 70.
  • No prior Janus Kinase 2 (JAK2) inhibitor treatment.
  • Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:
  • Practice effective barrier contraception during the entire study period and through 60 calendar days after the last dose of study agent
  • Ability to understand a written informed consent document, and the willingness to sign it.
  • Left ventricular cardiac ejection fraction of ≥50% by echocardiogram or multigated acquisition (MUGA) scan.
  • Willing to provide blood and tissue for research analysis. (encouraged but not necessary for inclusion in trial).
  • Adequate organ function as defined by the following laboratory values at screening:
  • Serum aspartate transaminase (AST), serum glutamic oxaloacetic transaminase (SGOT) and serum alanine transaminase (ALT), serum glutamic pyruvic transaminase (SGPT) < 2.5 x upper limit of normal (ULN).
  • Total serum bilirubin ≤1.5 x ULN. In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, the subject may be eligible).
  • Serum potassium ≥ 3.5 mmol/L. Supplementation and re-screening is allowed.
  • Estimated glomerular filtration rate (GFR) > 45 ml/min using Cockroft-Gault equation.
  • Platelets ≥ 100,000/mL independent of transfusion and/or growth factors within three months prior to randomization.
  • Hemoglobin ≥ 9.0 g/dL independent of transfusion and/or growth factors within three months prior to randomization.
  • Absolute neutrophil count ≥500/µL.
  • Serum albumin ≥ 3.0 g/dL.
  • Adequate coagulation defined by prothrombin time (PT) / international normalized ratio (INR) and partial thromboplastin time (PTT) ≤ 1x.5 ULN.

Who cannot join

  • Previously treated with pacritinib.
  • Prior systemic treatment with androgen deprivation therapy and/or first-generation anti-androgen (e.g. bicalutamide, nilutamide, flutamide) for biochemically recurrent prostate cancer. Prior androgen deprivation therapy (ADT) and/or first-generation anti-androgen in the (neo)adjuvant, definitive and/or salvage setting in conjunction with radiation or surgery is allowed provided last effective dose of ADT and/or first-generation anti-androgen is > 9 months prior to the date of randomization and the total duration of prior therapy is ≤ 36 months.
  • Prior treatment with 17α-hydroxy / 17,20-lyase (CYP17) inhibitor (e.g., ketoconazole, abiraterone acetate, galeterone) or next-generation androgen receptor antagonist including apalutamide or enzalutamide.
  • Prior chemotherapy for prostate cancer except if administered in the neoadjuvant or adjuvant setting and last dose <= 6 months from randomization.
  • Use of 5-alpha reductase inhibitor within 42 days prior to randomization.
  • Use of investigational agents within 28 days prior to randomization.
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  • Use of other prohibited medications within seven days prior to Cycle 1 Day 1 on study (see Appendix 3 and 4 for list of prohibited medications).
  • Systemic treatment with a strong Cytochrome P450 3A4 (CYP3A4) inhibitor or a strong cytochromes P450 (CYP450) inducer within 14 days prior to treatment Day 1.
  • Prior bilateral orchiectomy.
  • Uncontrolled hypertension.
  • Baseline severe hepatic impairment (Child-Pugh Class B \& C).
  • An intercurrent illness that is not controlled, such as active infection, psychiatric illness/social situations that would limit compliance with study requirements.
  • Any chronic medical condition requiring a higher dose of corticosteroid than an equivalent of 10 mg prednisone/prednisolone per day.
  • Significant recent bleeding history, as defined as National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade≥2 within three months prior to treatment Day 1, unless precipitated by an inciting event (e.g., surgery, trauma, or injury)
  • Systemic treatment with medications that increase the risk of bleeding, including anticoagulants (warfarin, direct oral anticoagulant, etc.), antiplatelet agents (except for aspirin dosages of ≤ 100mg/day), vascular endothelial growth factor (anti-VEGF) agents, and daily use of COX-1 inhibiting nonsteroidal anti-inflammatory agents (NSAIDs) within 14 days prior to treatment Day 1.
  • Systemic treatment with medications that can prolong the time from the start of the Q wave to the end of the T wave (QT interval) within 14 days prior to treatment Day 1. Shorter washout periods may be permitted with the approval of the principal incestigator, provided that the washout period is at least five half-lives of the drug prior to treatment Day 1.
  • Any history of CTCAE grade ≥2 cardiac conditions within six months before treatment Day 1. Patients with asymptomatic grade 2 non-dysrhythmia cardiovascular conditions may be considered for inclusion, with the approval of the PI, if stable and unlikely to affect patient safety.
  • QT corrected by the Fridericia method (QTcF) prolongation >450 ms or other factors that increase the risk for QT interval prolongation (e.g., heart failure, hypokalemia [defined as serum potassium <3.0 mEq/L that is persistent and refractory to correction]), or history of long QT interval syndrome.
  • New York Heart Association Class II, III, or IV congestive heart failure (Appendix 7).
  • Any active gastrointestinal (GI) or metabolic condition that could interfere with absorption of oral medication.
  • Active or uncontrolled inflammatory or chronic functional bowel disorder such as Crohn's disease, inflammatory bowel disease, chronic diarrhea, or chronic constipation.
  • Other malignancy within three years prior to treatment Day 1, other than curatively treated basal cell or squamous cell skin or corneal cancer; curatively treated carcinoma in situ of the cervix; or in situ breast carcinoma after complete surgical resection.
  • Uncontrolled intercurrent illness, including, but not limited to, ongoing active infection, psychiatric illness, or social situation that, in the judgment of the treating physician, would limit compliance with study requirements.
  • Known seropositivity for human immunodeficiency virus.
  • Known active hepatitis A, B, or C virus infection.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Froedtert & the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

This is a single-arm, open-label study using pacritinib for patients with histologically confirmed prostate adenocarcinoma, status post definitive treatment and biochemical recurrence.

Read the detailed description

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.

Conditions
Prostate Cancer
Being tested
Pacritinib
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • PacritinibDrug

    Also called SB1518

    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).

Study groups in NCT04635059
Study groupRoleWhat they receive
PacritinibExperimentalPacritinib is an oral drug.
Receives: Drug: Pacritinib

What is being measured

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

  1. The Number of Patients With Six-month PSA Progression-free Survival.

    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.

    Measured: Six months

Secondary outcomes (2)

  1. PSA Levels

    PSA level in blood is measured in units of nanograms per milliliter.

    Measured: Cycle1Day1 (month 0), every month up to month 4.

  2. Testosterone Measurement

    Serum testosterone will be measured in nanograms per deciliter.

    Measured: Baseline and three months

Timeline

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

  1. First posted18 Nov 2020
  2. Study start1 Jun 2021
  3. Primary completion30 Nov 2023
  4. Study completion27 Oct 2024

Why it stopped: futility and drug supplier in favor of new metastatic protocol.

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04635059
Sponsor's protocol ID
PRO00040162
Acronym
BLAST
Status last verified
Oct 2025
First submitted
4 Nov 2020
Last updated
17 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pacritinib in people with Prostate Cancer, run by Medical College of Wisconsin at 1 site in United States.

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 25 inclusion and 25 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: stopped early, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Yes. Results are posted in the registry (first posted 17 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Number of Patients With Six-month PSA Progression-free Survival. (time frame: Six 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 NCT04635059.

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 17 Nov 2025.

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