Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC

NCT06100705 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2000035188
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Metastatic Castration-resistant Prostate Cancer

Keywords

Sipuleucel-T; Bipolar Androgen Therapy

Outcome Measures

Primary Outcomes (1)

• To determine the immune response to PA2024 with BAT and Sipuleucel-T

  As measured by ELISPOT from blood samples in pg/ml

  Through the study completion, average 12 months

Secondary Outcomes (12)

• To determine antigen presenting cell (APC) cumulative activation

  Through the study completion, average 12 months

• To determine APC number

  Through the study completion, average 12 months

• To determine total nucleated cell count

  Through the study completion, average 12 months

• To determine T cell proliferation to PA2024

  Through the study completion, average 12 months

• To determine T cell proliferation to Prostatic Acid Phosphatase (PAP)

  Through the study completion, average 12 months

Study Arms (1)

Testosterone Cypionate + Sipuleucel-T

EXPERIMENTAL

Participants will start with testosterone injection every 4 weeks. The first dose of standard of care Sipuleucel-T will be prepared and infused after two doses of testosterone and will continue every 2 weeks for a total of 3 infusions at a standard schedule. The testosterone injection will continue once every 4 weeks until treatment discontinuation criteria are met.

Drug: Testosterone Cypionate; Drug: Sipuleucel-T

Interventions

Testosterone Cypionate DRUG

Testosterone Cypionate is an androgen and anabolic steroid medication which is used mainly in the treatment of low testosterone levels in men.

Also known as: DEPO-Testosterone

Testosterone Cypionate + Sipuleucel-T

Sipuleucel-T DRUG

Sipuleucel-T is the first FDA-approved immunotherapy in treatment of mCRPC. It is a therapeutic cancer vaccine composed of activated autologous dendritic cells loaded with an engineered fusion protein of prostatic acid phosphatase and granulocyte-macrophage colony-stimulating factor, PAP-GMCSF, also called PA2024. This cellular product is prepared in three steps: (1) leukapheresis to isolate CD54+ dendritic cells, (2) the cells and harvested and cultured with PA2024 ex vivo, and (3) re-infusion of the activated DC into the original patient. The preparation and administration of this autologous cellular product are done every 2 weeks for a total of three infusions and is designed to elicit an immune response to prostatic acid phosphatase.

Also known as: Provenge

Testosterone Cypionate + Sipuleucel-T

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• By measurable disease: Progressive disease by RECIST v1.1 criteria
• By non-measurable disease
• i. Soft tissue disease: The appearance of 1 or more new lesions, and/or unequivocal worsening of non-measurable disease when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response.
• ii. Bone disease: Appearance of 2 or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response. Increased uptake of pre-existing lesions on bone scan does not constitute progression.
• Castration status confirmed by serum testosterone level \<50ng/dL
• ECOG Performance Status of 0 or 1.
• Adequate liver function:
• Bilirubin \<2.0 x institutional upper limit of normal (UNL)
• AST (SGOT) \<2.5 x UNL

You may not qualify if:

• 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 start of treatment.
• 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.

Sponsors & Collaborators

• Yale University: lead
• Dendreon: collaborator

Study Sites (1)

Yale Cancer Center

New Haven, Connecticut, 06510, United States

RECRUITING

MeSH Terms

Interventions

testosterone 17 beta-cypionate; sipuleucel-T

Study Officials

• Joseph W Kim, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Kane

CONTACT

7733696904; Laura.Kane@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine (Medical Oncology)

Model Details: open-label, single-arm phase II study

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 25, 2023
• Study Start: December 20, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: November 4, 2025

Record last verified: 2025-10

Locations

US (1)