Sipuleucel-T + Hormonal Therapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Jingsong Zhang, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must be taking: LHRH analog, NHA

Must not be taking: Chemotherapy, Radiotherapy

Disqualifiers: Brain metastases, Liver metastases, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This study is designed to test the hypothesis that using Sipuleucel-T (Provenge) in combination with new hormonal agents (NHA) (abiraterone, enzalutamide, apalutamide) for the treatment of participants with asymptomatic metastatic castration resistant prostate cancer (mCRPC) and no visceral metastases would enhance the activation of antigen presenting cells (APC) by sipuleucel-T.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you are already on certain hormonal therapies for prostate cancer. If you are taking investigational drugs or have had recent chemotherapy or radiotherapy, you may need to stop those before joining the trial.

What data supports the effectiveness of the treatment Sipuleucel-T for prostate cancer?

Research shows that Sipuleucel-T, a treatment that helps the immune system fight prostate cancer, improved survival by about 4 months in patients with advanced prostate cancer compared to those who did not receive it. This suggests it could be beneficial when combined with other treatments.

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Is Sipuleucel-T safe for humans?

Sipuleucel-T has been shown to have a favorable safety profile in multiple studies for prostate cancer, with minimal toxicity and manageable side effects, making it suitable for combination with other treatments.

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What makes the treatment Sipuleucel-T unique for prostate cancer?

Sipuleucel-T is unique because it is an immunotherapy that uses the patient's own immune cells to fight prostate cancer, which is different from traditional treatments like chemotherapy or hormone therapy. It has shown to improve survival in men with advanced prostate cancer by stimulating an immune response specifically against the cancer.

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Eligibility Criteria

This trial is for men over 18 with metastatic prostate cancer that's not causing severe symptoms. They must be on hormone therapy and have a rising PSA level but no new cancer spread on scans. Participants need good organ function, controlled HIV if present, and can't have had recent chemotherapy or radiotherapy, prior Sipuleucel-T treatment, significant heart issues, or other serious illnesses.

Inclusion Criteria

I am a man who can father children and will use birth control during the study.

Ability to understand and the willingness to sign a written informed consent document

My heart functions well despite a history of heart issues.

Exclusion Criteria

I haven't had chemotherapy or radiotherapy in the last 4 weeks.

I have cancer that has spread to my brain or liver.

You have taken an experimental medication within 30 days before starting treatment with Sipuleucel-T.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Sipuleucel-T with or without New Hormonal Agents (NHA) for the treatment of metastatic castration resistant prostate cancer

4 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including IgG responses and PSA progression

Up to 44 weeks

Participant Groups

The study tests whether combining Sipuleucel-T (Provenge) with new hormonal agents like abiraterone, enzalutamide, or apalutamide improves immune system activation in men with advanced prostate cancer without visceral metastases. It aims to see if this combination can better target the cancer cells.

Group I: Sipuleucel-T without NHA Experimental Treatment 1 Intervention

Participants will discontinue use of New Hormonal Agents (NHA) while receiving sipuleucel-t as standard of care.

Group II: Sipuleucel-T with NHA Experimental Treatment 4 Interventions

Participants will continue taking New Hormonal Agents (NHA) while receiving sipuleucel-t as standard of care.

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 Nearby Select from list below to view details:

Moffitt Cancer Center Tampa, FL

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute Lead Sponsor

Dendreon Industry Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

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.

2. United States pubmed.ncbi.nlm.nih.gov

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).

3. United States pubmed.ncbi.nlm.nih.gov

Sipuleucel-T immunotherapy for castration-resistant prostate cancer. [2023] Sipuleucel-T, an autologous active cellular immunotherapy, has shown evidence of efficacy in reducing the risk of death among men with metastatic castration-resistant prostate cancer.

4. United States pubmed.ncbi.nlm.nih.gov

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.

5. United States pubmed.ncbi.nlm.nih.gov

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.

6. England pubmed.ncbi.nlm.nih.gov

Sipuleucel-T: harbinger of a new age of therapeutics for prostate cancer. [2021] Sipuleucel-T (Provenge) is the first therapeutic cancer vaccine approved by the US FDA. The approval heralds the long-awaited promise of improved patient survival with minimal toxicity by therapies designed to generate an active, specific anticancer immune response. The development of this first-in-class agent as well as other therapeutic vaccines in clinical evaluation has also led to a better understanding of relevant patient populations and end points for clinical trials. This article discusses the development and approval of sipuleucel-T in the context of other approved therapies for prostate cancer, as well as controversies and novel paradigms brought about by this new agent.

7. England pubmed.ncbi.nlm.nih.gov

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.