Sipuleucel-T + Hormonal Therapy for Prostate Cancer

Overseen By Jingsong Zhang, MD, PhD

Age: 18+

Sex: Male

Trial Phase: Phase 2

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 All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

26 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 5 6}

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. ^{1 2 4 5 7}

Research Team

Jingsong Zhang, MD

Principal Investigator

Moffitt Cancer Center

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.

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

Treatment Details

Interventions

• Abiraterone
• Apalutamide
• Enzalutamide
• Sipuleucel-T

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Dendreon

Industry Sponsor

Trials

30

Recruited

5,200+

Findings from Research

Sipuleucel-T (Provenge) has been shown to provide a significant survival benefit for men with metastatic castration-resistant prostate cancer, improving median survival by 4.1 months compared to placebo (25.8 vs 21.7 months) in a Phase III trial involving 512 patients.

The treatment has a favorable toxicity profile and manageable administration, making it a promising option to combine with other standard therapies for prostate cancer, potentially enhancing overall treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sipuleucel-T for prostate cancer: the immunotherapy era has commenced. Buonerba, C., Ferro, M., Di Lorenzo, G.[2016]

Sipuleucel-T, an autologous cellular immunotherapy, showed a median time to biochemical failure of 18.0 months compared to 15.4 months for the control group, indicating a potential benefit, although the difference was not statistically significant (P = 0.737).

Patients receiving sipuleucel-T experienced a 48% increase in PSA doubling time after testosterone recovery, suggesting enhanced biological activity, and the treatment was generally well tolerated with common side effects including fatigue, chills, and fever.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of autologous cellular immunotherapy with sipuleucel-T in androgen-dependent prostate cancer. Beer, TM., Bernstein, GT., Corman, JM., et al.[2020]

Sipuleucel-T, an autologous immunotherapy, significantly reduced the risk of death by 22% in men with metastatic castration-resistant prostate cancer, leading to a median survival increase of 4.1 months compared to placebo (25.8 months vs. 21.7 months).

While sipuleucel-T improved overall survival, it did not affect the time to disease progression, and common side effects included chills, fever, and headache, indicating a manageable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sipuleucel-T immunotherapy for castration-resistant prostate cancer. Kantoff, PW., Higano, CS., Shore, ND., et al.[2023]

Sipuleucel-T is an autologous cellular immunotherapy that effectively stimulates the immune system to target prostate cancer, leading to prolonged overall survival in men with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer (CRPC).

The findings from phase III studies highlight the efficacy and safety of sipuleucel-T, suggesting its important role in the treatment of advanced prostate cancer and indicating potential directions for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sipuleucel-T for the treatment of advanced prostate cancer. Frohlich, MW.[2016]

Sipuleucel-T therapy for prostate cancer is generally safe, with most adverse events being mild to moderate and resolving within two days, including chills (53.1%) and pyrexia (31.3%).

There was no significant increase in serious adverse events or autoimmune complications compared to controls, indicating that sipuleucel-T can be administered safely in an outpatient setting.

NCBI (Pubmed)

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. Hall, SJ., Klotz, L., Pantuck, AJ., et al.[2016]

Sipuleucel-T (Provenge) is the first FDA-approved therapeutic cancer vaccine, designed to enhance patient survival with minimal side effects by stimulating a specific immune response against cancer.

The development of sipuleucel-T has improved our understanding of patient populations and clinical trial endpoints for prostate cancer therapies, highlighting its significance in the evolution of cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sipuleucel-T: harbinger of a new age of therapeutics for prostate cancer. Madan, RA., Gulley, JL.[2021]

Sipuleucel-T is an innovative immunotherapy that uses a patient's own dendritic cells to target prostate cancer, showing promising results in reducing prostate-specific antigen levels and extending the time before these levels double in men with biochemically relapsed prostate cancer.

In Phase III trials, sipuleucel-T significantly improved median overall survival in men with asymptomatic, metastatic hormone-refractory prostate cancer compared to placebo, indicating its potential as an effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sipuleucel-T (APC8015) for prostate cancer. So-Rosillo, R., Small, EJ.[2022]

References

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

Sipuleucel-T for prostate cancer: the immunotherapy era has commenced. [2016]

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

Randomized trial of autologous cellular immunotherapy with sipuleucel-T in androgen-dependent prostate cancer. [2020]

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

Sipuleucel-T immunotherapy for castration-resistant prostate cancer. [2023]

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

Sipuleucel-T for the treatment of advanced prostate cancer. [2016]

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]

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

Sipuleucel-T: harbinger of a new age of therapeutics for prostate cancer. [2021]

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

Sipuleucel-T (APC8015) for prostate cancer. [2022]