RECRUITING

Sipuleucel-T Combined with Bipolar Androgen Therapy in Men with MCRPC

Conditions

Metastatic Castration-resistant Prostate Cancer Sipuleucel-T Bipolar Androgen Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an open-label, single-arm phase II study of bipolar androgen therapy (BAT) given in addition with standard of care Sipuleucel-T to determine the interferon (IFN) gamma Enzyme-linked Immunospot (ELISPOT) response rate to PA2024 (an engineered fusion protein of prostatic acid phosphatase and granulocyte-macrophage colony-stimulating factor which the activated autologous dendritic cells in the Sipuleucel-T vaccine are loaded with) in patients with metastatic castration resistant prostate cancer (mCRPC).

Official Title

A Single Arm Open-label, Phase II Study of Sipuleucel-T with Bipolar Androgen Therapy in Men with Metastatic Castration-resistant Prostate Cancer

Quick Facts

Study Start:2023-12-20

Study Completion:2028-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06100705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Written informed consent obtained prior to the initiation of study procedures. * Patients who meet the US FDA-approved indication for Sipuleucel-T: for asymptomatic or minimally symptomatic mCRPC at the discretion of the treating investigator. * Histologically confirmed adenocarcinoma of the prostate. * Metastatic disease as evidenced by soft tissue and/or bony metastases on baseline bone scan and/or computed tomography (CT) scan or Magnetic Resonance Image (MRI). * Progressive castration-resistant prostate cancer (CRCP): Participants must have current or historical evidence of disease progression concomitant with surgical or medical castration and during immediate past systemic therapy, as demonstrated by (a) PSA progression, or (b) progression of measurable disease, or (c) progression of non-measurable disease as defined below: 1. By PSA: two consecutively rising PSA values, at least 7 days apart, each ≥ 1.0 ng/mL and ≥ 50% above the minimum PSA observed during castration therapy or above the pre-treatment value if there was no response. 2. By measurable disease: Progressive disease by RECIST v1.1 criteria 3. By non-measurable disease * Castration status confirmed by serum testosterone level \<50ng/dL * ECOG Performance Status of 0 or 1. * Adequate liver function: 1. Bilirubin \<2.0 x institutional upper limit of normal (UNL) 2. AST (SGOT) \<2.5 x UNL 3. ALT (SGPT) \<2.5 x UNL * Acceptable renal function * Acceptable hematologic function: 1. Absolute neutrophil count (ANC) \> 1.0 x10\^9 cells /L) 2. Platelet counts \> 100 x 10\^9 / L) 3. Hemoglobin \>9 g/dL	* PSA \>20ng/dL within the 4 weeks prior to signing ICF * Previously treated with three or more FDA-approved androgen/AR signaling inhibitors (ASI) (e.g., abiraterone, enzalutamide, apalutamide, darolutamide). No minimum number of ASI is required. * Prior chemotherapy for mCRPC. However, prior chemotherapy administered for mCSPC is allowed unless the disease progression to CRPC occurred within 12 months from the last dose of chemotherapy. * Prior treatment with Sipuleucel-T or supraphysiologic dose of testosterone treatment for prostate cancer. * Prior systemic treatment with ASI, PARP inhibitor or Radium-223 or other systemic anti-cancer therapy for prostate cancer within 4 weeks prior to eligibility confirmation. * Prior prednisone \>10mg (or its equivalent) within 2 weeks prior to registration. * Prior immunotherapy or Lu177 PSMA radioligand therapy within 6 weeks prior to registration. * Prior palliative radiotherapy within 2 weeks prior to registration. * Radiographic evidence of hepatic metastases * Use of narcotics including tramadol or stronger for cancer-related pain within 4 weeks prior to signing ICF. Use of NSAIDs or acetaminophen is allowed. * Active autoimmune disease requiring systemic corticosteroids of prednisone greater than 10mg a day or the equivalent dose of other corticosteroids. * Known active HIV, Hepatitis B or Hepatitis C or Human T cell Lymphotropic virus (HTLV)-1 infection. Testing is not required. Note: Participants with resolved, historic HIV, Hepatitis B or Hepatitis C or Human T cell Lymphotropic virus (HTLV)-1 will be assessed by the PI and deemed eligible if their viral infections are in remission: without detectable viruses and secondary immunodeficiency, and without requiring any treatments that affects immune function. Eligibility will be determined after a discussion with the PI and adequate standard clinical tests are acquired to prove that they are in remission. * Active infection requiring parenteral antibiotic therapy or causing fever (temperature \>100.5 in Fahrenheit scale) within 1 week prior to registration. * Life expectancy of less than 6 months prior to signing ICF. * Any medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives.

Inclusion Criteria

Exclusion Criteria

* Written informed consent obtained prior to the initiation of study procedures.
* Patients who meet the US FDA-approved indication for Sipuleucel-T: for asymptomatic or minimally symptomatic mCRPC at the discretion of the treating investigator.
* Histologically confirmed adenocarcinoma of the prostate.
* Metastatic disease as evidenced by soft tissue and/or bony metastases on baseline bone scan and/or computed tomography (CT) scan or Magnetic Resonance Image (MRI).
* Progressive castration-resistant prostate cancer (CRCP): Participants must have current or historical evidence of disease progression concomitant with surgical or medical castration and during immediate past systemic therapy, as demonstrated by (a) PSA progression, or (b) progression of measurable disease, or (c) progression of non-measurable disease as defined below:
1. By PSA: two consecutively rising PSA values, at least 7 days apart, each ≥ 1.0 ng/mL and ≥ 50% above the minimum PSA observed during castration therapy or above the pre-treatment value if there was no response.
2. By measurable disease: Progressive disease by RECIST v1.1 criteria
3. By non-measurable disease
* Castration status confirmed by serum testosterone level \<50ng/dL
* ECOG Performance Status of 0 or 1.
* Adequate liver function:
1. Bilirubin \<2.0 x institutional upper limit of normal (UNL)
2. AST (SGOT) \<2.5 x UNL
3. ALT (SGPT) \<2.5 x UNL
* Acceptable renal function
* Acceptable hematologic function:
1. Absolute neutrophil count (ANC) \> 1.0 x10\^9 cells /L)
2. Platelet counts \> 100 x 10\^9 / L)
3. Hemoglobin \>9 g/dL

* PSA \>20ng/dL within the 4 weeks prior to signing ICF
* Previously treated with three or more FDA-approved androgen/AR signaling inhibitors (ASI) (e.g., abiraterone, enzalutamide, apalutamide, darolutamide). No minimum number of ASI is required.
* Prior chemotherapy for mCRPC. However, prior chemotherapy administered for mCSPC is allowed unless the disease progression to CRPC occurred within 12 months from the last dose of chemotherapy.
* Prior treatment with Sipuleucel-T or supraphysiologic dose of testosterone treatment for prostate cancer.
* Prior systemic treatment with ASI, PARP inhibitor or Radium-223 or other systemic anti-cancer therapy for prostate cancer within 4 weeks prior to eligibility confirmation.
* Prior prednisone \>10mg (or its equivalent) within 2 weeks prior to registration.
* Prior immunotherapy or Lu177 PSMA radioligand therapy within 6 weeks prior to registration.
* Prior palliative radiotherapy within 2 weeks prior to registration.
* Radiographic evidence of hepatic metastases
* Use of narcotics including tramadol or stronger for cancer-related pain within 4 weeks prior to signing ICF. Use of NSAIDs or acetaminophen is allowed.
* Active autoimmune disease requiring systemic corticosteroids of prednisone greater than 10mg a day or the equivalent dose of other corticosteroids.
* Known active HIV, Hepatitis B or Hepatitis C or Human T cell Lymphotropic virus (HTLV)-1 infection. Testing is not required. Note: Participants with resolved, historic HIV, Hepatitis B or Hepatitis C or Human T cell Lymphotropic virus (HTLV)-1 will be assessed by the PI and deemed eligible if their viral infections are in remission: without detectable viruses and secondary immunodeficiency, and without requiring any treatments that affects immune function. Eligibility will be determined after a discussion with the PI and adequate standard clinical tests are acquired to prove that they are in remission.
* Active infection requiring parenteral antibiotic therapy or causing fever (temperature \>100.5 in Fahrenheit scale) within 1 week prior to registration.
* Life expectancy of less than 6 months prior to signing ICF.
* Any medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives.

Contacts and Locations

Study Contact

Julie Holub

CONTACT

860-304-0546

Julie.holub@yale.edu

Principal Investigator

Joseph W Kim, MD

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Yale Cancer Center

New Haven, Connecticut, 06510

United States

Collaborators and Investigators

Sponsor: Yale University

Joseph W Kim, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-20

Study Completion Date2028-03

Study Record Updates

Study Start Date2023-12-20

Study Completion Date2028-03

Terms related to this study

Keywords Provided by Researchers

Sipuleucel-T
Bipolar Androgen Therapy

Additional Relevant MeSH Terms

Metastatic Castration-resistant Prostate Cancer