Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Yale University
Must not be taking: Androgen inhibitors, Chemotherapy, Immunotherapy, others
Disqualifiers: Hepatic metastases, Active infection, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?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).
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, certain treatments like androgen/AR signaling inhibitors, chemotherapy for mCRPC, and some other therapies must not have been used recently. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment Sipuleucel-T for prostate cancer?
Research shows that Sipuleucel-T, an immunotherapy, improves overall survival in men with advanced prostate cancer, specifically those with metastatic castration-resistant prostate cancer. Clinical trials demonstrated a significant survival advantage, with a 4.1-month improvement in median survival compared to placebo.
12345Is Sipuleucel-T safe for humans?
Sipuleucel-T has been tested in several clinical trials for prostate cancer, and common side effects include mild to moderate muscle pain, chills, fever, and tremor, which usually go away quickly.
14678How is the treatment Sipuleucel-T + BAT unique for prostate cancer?
Sipuleucel-T is a unique treatment for prostate cancer because it uses the patient's own immune cells to fight the cancer, which is different from traditional treatments like chemotherapy. It involves collecting immune cells from the patient, treating them to target prostate cancer, and then reintroducing them into the body to stimulate an immune response. This approach has shown to improve survival in patients with advanced prostate cancer.
12349Eligibility Criteria
Men with metastatic castration-resistant prostate cancer (mCRPC) who have not been treated with more than two androgen/AR signaling inhibitors, no prior chemotherapy for mCRPC within the last year, or recent systemic anti-cancer therapy. Participants must be in good health otherwise, with proper liver and kidney function, a low PSA level (<20ng/dL), and an ECOG Performance Status of 0 or 1.Inclusion Criteria
Your bilirubin level is below 2.0 times the UNL.
My PSA levels have risen twice, each time by at least 50% and are over 1.0 ng/mL.
Your serum creatinine is below 2.0x the upper normal limit.
+20 more
Exclusion Criteria
Radiographic evidence of hepatic metastases
I have received Sipuleucel-T or high-dose testosterone for prostate cancer.
I have been treated with 3 or more prostate cancer drugs like abiraterone.
+12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive testosterone injections every 4 weeks and Sipuleucel-T infusions every 2 weeks for a total of 3 infusions
12 weeks
3 visits (in-person) for Sipuleucel-T infusions, additional visits for testosterone injections
Follow-up
Participants are monitored for safety, immune response, and clinical outcomes
12 months
Regular assessments every 4 weeks, radiographic assessments every 12 weeks
Long-term follow-up
Participants are monitored for overall survival and progression-free survival
Up to 5 years
Participant Groups
This phase II trial is testing the combination of Sipuleucel-T (a prostate cancer vaccine) with bipolar androgen therapy (BAT), using Testosterone Cypionate to see if it can boost immune response against prostate cancer cells in men whose disease has resisted standard hormonal treatments.
1Treatment groups
Experimental Treatment
Group I: Testosterone Cypionate + Sipuleucel-TExperimental Treatment2 Interventions
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.
Sipuleucel-T is already approved in United States for the following indications:
🇺🇸 Approved in United States as Provenge for:
- Asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Yale Cancer CenterNew Haven, CT
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Who Is Running the Clinical Trial?
Yale UniversityLead Sponsor
DendreonIndustry Sponsor
References
Sipuleucel-T (APC8015) for prostate cancer. [2022]Sipuleucel-T (Provenge; APC8015; Dendreon Corp, WA, USA) is a novel immunotherapeutic cellular product, which includes autologous dendritic cells pulsed ex vivo with a recombinant fusion protein (PA2024) consisting of granulocyte macrophage colony-stimulating factor and prostatic acid phosphatase. Two Phase II trials in men with androgen-dependent biochemically relapsed prostate cancer have demonstrated a decrease in prostate-specific antigen and prolongation in prostate-specific antigen doubling time. In men with hormone-refractory prostate cancer, clinical trials have demonstrated both biological activity and clinical response to sipuleucel-T. Data from two Phase III trials in men with asymptomatic, metastatic hormone-refractory prostate cancer demonstrated an improved median overall survival in men who received sipuleucel-T compared with placebo. Clinical trials are ongoing or are being developed to evaluate sipuleucel-T in various prostate cancer disease states and in combination with other treatment modalities.
Sipuleucel-T in patients with metastatic castration-resistant prostate cancer: an insight for oncologists. [2021]Sipuleucel-T represents a novel immunotherapeutic compound designed to stimulate an immune response against castration-resistant prostate cancer (CRPC). Sipuleucel-T is an autologous active cellular immunotherapy product, which includes autologous dendritic cells pulsed ex vivo with PAP2024, a recombinant fusion protein made of prostatic acid phosphatase and granulocyte-macrophage colony-stimulating factor. Despite the lack of prostate-specific antigen and objective response, a recent phase III randomized trial demonstrated a significant improvement in overall survival in asymptomatic and minimally symptomatic CRPC patients. This review summarizes the clinical development of Sipuleucel-T in CRPC that led to the regulatory approval of this compound in the USA.
Sipuleucel-T for the treatment of advanced prostate cancer. [2016]Sipuleucel-T is an autologous cellular immunotherapy designed to stimulate an immune response to prostate cancer that prolongs the overall survival of men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (CRPC). The clinical development program and key efficacy, safety, and immune response findings from the phase III studies are presented. The integration of sipuleucel-T into the treatment paradigm of advanced prostate cancer and future directions for research are discussed.
Building on sipuleucel-T for immunologic treatment of castration-resistant prostate cancer. [2022]Sipuleucel-T is an autologous cellular immunotherapy approved by the US Food and Drug Administration for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. Its mechanism of action is based on stimulation of the patient's own immune system to target prostate cancer. Peripheral blood mononuclear cells, including antigen-presenting cells and T cells, are obtained from patients via leukapheresis and treated ex vivo with PA2024, a fusion protein consisting of prostatic acid phosphatase/granulocyte-macrophage colony-stimulating factor antigen.
Sipuleucel-T for prostate cancer: the immunotherapy era has commenced. [2016]The US FDA recently approved sipuleucel-T (Provenge(®), Dendreon, Inc., WA, USA) on the grounds of the results reported by a Phase III trial, which are presented and discussed in detail in this article. This study was conducted in 512 metastatic castration-resistant prostate cancer patients randomized in a 2:1 ratio to receive either active therapy or placebo. Although no difference in time to progression was observed, a survival advantage was achieved, with a statistically meaningful 4.1-month improvement in median survival in the active arm with respect to the placebo arm (25.8 vs 21.7 months). In view of its favorable toxicity profile and manageable route of administration, sipuleucel-T is the ideal agent to be combined with other standard treatments, which include hormonal, cytotoxic and biological agents, and radiotherapy. Sipuleucel-T opens exciting new paradigms for prostate cancer and increases the possibility of survival prolongation for men with this deadly disease.
Integrated safety data from 4 randomized, double-blind, controlled trials of autologous cellular immunotherapy with sipuleucel-T in patients with prostate cancer. [2016]We describe the safety of sipuleucel-T using an integrated analysis of 4 randomized, controlled studies in patients with prostate cancer.
Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer. [2022]Sipuleucel-T is an investigational active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. The safety and efficacy of sipuleucel-T was evaluated in 2 identically designed, randomized, double-blind, placebo-controlled trials (D9901 and D9902A) conducted in men with advanced prostate cancer.
Sipuleucel-T (Provenge): active cellular immunotherapy for advanced prostate cancer. [2010](1) Sipuleucel-T (Provenge) is an active cellular immunotherapy (therapeutic vaccine) that is designed to stimulate the patient's T-cells to recognize and attack prostate cancer cells that express prostatic acid phosphatase (PAP) antigen. (2) Sipuleucel-T demonstrated a survival benefit in men with advanced androgen-independent prostate cancer (AIPC), although this preliminary finding requires confirmation in larger trials. (3) Mild to moderate myalgia, chills, fever, and tremor are the most commonly reported adverse events for patients receiving sipuleucel-T. These events generally resolve quickly. (4) More studies are needed to evaluate sipuleucel-T in the earlier stages of prostate cancer and in combination with conventional therapies.
Randomized trial of autologous cellular immunotherapy with sipuleucel-T in androgen-dependent prostate cancer. [2020]Sipuleucel-T, an autologous cellular immunotherapy, was investigated in a randomized, double-blind, controlled trial to determine its biologic activity in androgen-dependent prostate cancer (ADPC).