Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC
A Single Arm Open-label, Phase II Study of Sipuleucel-T With Bipolar Androgen Therapy in Men With Metastatic Castration-resistant Prostate Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Injections, Infusions, Biopsies
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "DEPO-Testosterone (testosterone cypionate) IM injection will continue until disease progression, unacceptable toxicity, or withdrawal of consent to treatment."
- "In the event of suspected/radiographic disease progression, tumor biopsy may be performed as a standard of care to confirm progression."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests bipolar androgen therapy (BAT), a testosterone treatment, given with sipuleucel-T. It measures the immune system’s response to the treatment. It is for men whose prostate cancer has spread and worsened despite very low testosterone, with no symptoms or only mild symptoms.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Sign a consent form before any study procedures.
- Qualify for sipuleucel-T treatment, as judged by the study doctor.
- Have prostate adenocarcinoma, a type of prostate cancer, confirmed by a tissue test.
- Have scans showing cancer has spread to bones or other tissues.
- Have cancer that has worsened despite treatment to lower testosterone and during the most recent whole-body treatment, based on PSA blood tests or scans.
- Have a blood testosterone level below 50 ng/dL.
- Be fully active or able to do light work despite some limits on hard physical activity.
- Meet the study’s blood test limits for liver and kidney health, infection-fighting cells, platelets, and hemoglobin.
Who can't join
- Have PSA above 20 ng/dL within 4 weeks before signing consent, cancer spread to the liver, or an expected lifespan under 6 months.
- Have had chemotherapy for prostate cancer that resists testosterone-lowering treatment. Earlier chemotherapy is allowed only if this resistance did not develop within 12 months after the last dose.
- Have had sipuleucel-T or very high-dose testosterone treatment for prostate cancer.
- Have had hormone-related drugs, PARP inhibitors, radium-223, or other whole-body prostate cancer treatment within 4 weeks before study treatment; or immune treatment or Lu177 PSMA radiation treatment within 6 weeks before registration.
- Have used prednisone above 10 mg, or a similar steroid dose, or had radiation to ease symptoms within 2 weeks before registration. An active disease in which the immune system attacks the body also excludes you if it needs more than 10 mg of prednisone daily or a similar steroid dose.
- Have used tramadol or stronger opioid pain medicine for cancer pain within 4 weeks before consent. Acetaminophen and anti-inflammatory pain medicines are allowed.
- Have active HIV, hepatitis B or C, or HTLV-1 infection. Past infections may be allowed after review and testing. An infection needing antibiotics by injection or causing fever above 100.5°F within 1 week before registration also excludes you.
- Have another condition or medical treatment that the study doctor believes could prevent you from following study rules or affect the study’s goals.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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 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: 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 a) Serum creatinine \<2.0 x UNL * 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 Exclusion Criteria: * PSA \>20ng/dL within the 4 weeks prior to signing ICF * 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 androgen/Androgen signaling Inhibitor (ASI, e.,g, abiraterone, enzalutamide, apalutamide, darolutamide, or bicalutamide), 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.
Study sites (1)
CT
- Yale Cancer Center · New Haven, CT 06510Joseph W Kim · Study contact · 12037376467 · joseph.w.kim@yale.eduMore trials in New Haven