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Pacritinib for Biochemical Relapse After Definitive Treatment for Prostate Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Pacritinib for Biochemical Relapse After Definitive Treatment for Prostate Cancer

NCT04635059•Medical College of Wisconsin

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.

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Patients aged ≥ 18 years.
•2. Histologically or cytologically confirmed prostate adenocarcinoma.
•3. Prior radical prostatectomy or definitive radiation.
•4. 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.
•5. 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).
•6. Screening PSA \> 0.5 ng/mL.
•7. 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.
•8. Screening serum testosterone \> 150 ng/dL.
•9. Eastern Cooperative Oncology Group (ECOG) Performance Status grade 0 or 1 or Karnofsky Performance Status ≥ 70.
•10. No prior Janus Kinase 2 (JAK2) inhibitor treatment.
+15 more criteria

Exclusion Criteria

•1. Previously treated with pacritinib.
•2. 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.
•3. 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.
•4. Prior chemotherapy for prostate cancer except if administered in the neoadjuvant or adjuvant setting and last dose \<= 6 months from randomization.
•5. Use of 5-alpha reductase inhibitor within 42 days prior to randomization.
•6. Use of investigational agents within 28 days prior to randomization.
•7. 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).
•8. 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.
•9. Prior bilateral orchiectomy.
•10. Uncontrolled hypertension.
+15 more criteria

Locations (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Key Dates

Start Date

June 1, 2021

Primary Completion Date

November 30, 2023

Completion Date

October 27, 2024

Last Updated

November 17, 2025

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

Pacritinib

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pacritinib for Biochemical Relapse After Definitive Treatment for Prostate Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

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