Cellular Immunotherapy for Prostate Cancer

(OU-SCC-EXCITE Trial)

Recruiting at 1 trial location

Overseen By Lead Onco Nurse

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: University of Oklahoma

Must not be taking: Immunosuppressants, Antibiotics

Disqualifiers: Other malignancies, Allergic reactions, others

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

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

Compensation: Varies

Number of Visits: 3

Duration: 14 weeks

13 Participants Needed

Trial Summary

What is the purpose of this trial?

Proposed immunotherapy with an extended course of Sipuleucel-T treatment may induce a more robust immune response and improve the anti-cancer efficacy of Sipuleucel-T in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you require more than 10mg of Prednisone daily or have had recent infections needing antibiotics.

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

Research shows that Sipuleucel-T, a type of treatment that uses a patient's own immune cells, can help men with advanced prostate cancer live longer. In studies, it reduced the risk of death and increased survival by about 4 months for men with certain types of prostate cancer. ^{1 2 3 4 5}

Is Sipuleucel-T (Provenge) safe for humans?

Sipuleucel-T (Provenge) is generally considered safe, with the most common side effects being mild to moderate flu-like symptoms such as chills, fatigue, fever, back pain, nausea, joint aches, and headaches, which usually resolve quickly. ^{1 3 4 6 7}

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

Sipuleucel-T is a unique treatment for prostate cancer because it is an autologous cellular immunotherapy, meaning it uses the patient's own immune cells to fight the cancer. It is designed to stimulate the immune system to target prostate cancer cells specifically, offering a survival benefit with a favorable safety profile compared to more traditional treatments. ^{1 2 3 6 8}

Research Team

Kelly Stratton, MD

Principal Investigator

Investigator

Eligibility Criteria

This trial is for men over 18 with advanced prostate cancer that has spread, who haven't had Sipuleucel-T before and are expected to live at least another 6 months. They should be fairly active (able to care for themselves) and not have other cancers needing treatment soon or serious infections recently.

Inclusion Criteria

I am a man aged 18 or older.

Life expectancy of ≥ 6 months

My prostate cancer has spread to other parts of my body.

Exclusion Criteria

I have cancer other than prostate cancer that won't need treatment in the next 6 months.

I have previously received Provenge® treatment.

I have not taken antibiotics for an infection in the week before signing up.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Sipuleucel-T immunotherapy in three doses at weeks 0, 2, and 12-14

14 weeks

3 visits (in-person)

Follow-up

Participants are monitored for immune response and tumor response after treatment

up to 12 months

Treatment Details

Interventions

• Sipuleucel-T

Trial Overview The study tests if giving more doses of the immunotherapy drug Sipuleucel-T can boost the immune system better to fight metastatic Castration-Resistant Prostate Cancer than the standard treatment course.

Participant Groups

Group I: Extended course of Sipuleucel-T treatment Experimental Treatment 1 Intervention

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?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Dendreon

Industry Sponsor

Trials

30

Recruited

5,200+

Findings from Research

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, 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 (Provenge) is the first approved autologous therapeutic cancer vaccine for men with asymptomatic or minimally symptomatic castrate-resistant metastatic prostate cancer, demonstrating a significant median survival increase of 4.1 months and a 22.5% reduction in risk of death after three infusions.

The treatment has a favorable safety profile, with the most common side effects being flu-like symptoms, allowing for potential combination with other therapies and earlier use in the disease progression, maximizing therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sipuleucel-T (Provenge) autologous vaccine approved for treatment of men with asymptomatic or minimally symptomatic castrate-resistant metastatic prostate cancer. Gardner, TA., Elzey, BD., Hahn, NM.[2016]

Sipuleucel-T (PROVENGE) is the first FDA-approved autologous cellular immunotherapy for prostate cancer, specifically targeting men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.

This treatment has been shown to improve survival rates in patients with advanced prostate cancer, highlighting its potential as a significant advancement in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy for advanced prostate cancer: a novel treatment option to improve survival. Peskin, SR.[2016]

Sipuleucel-T, an FDA-approved immunotherapy for advanced prostate cancer, effectively activates antigen presenting cells (APCs) and induces immune responses, which are linked to improved overall survival (OS) in patients, as shown in a study of 737 participants across three phase 3 trials.

The therapy demonstrated significant APC activation with each dose, and 78.8% of monitored subjects developed antigen-specific immune responses, further correlating these responses with prolonged OS, highlighting its efficacy as a cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sipuleucel-T immune parameters correlate with survival: an analysis of the randomized phase 3 clinical trials in men with castration-resistant prostate cancer. Sheikh, NA., Petrylak, D., Kantoff, PW., et al.[2022]

Sipuleucel-T (Provenge) is an active immunotherapy that helps the immune system recognize and attack prostate cancer cells, showing a survival benefit in men with advanced androgen-independent prostate cancer, although further confirmation in larger trials is needed.

The most common side effects of sipuleucel-T include mild to moderate myalgia, chills, fever, and tremor, which typically resolve quickly, indicating a manageable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sipuleucel-T (Provenge): active cellular immunotherapy for advanced prostate cancer. McKarney, I.[2010]

Sipuleucel-T, an immunotherapy vaccine made from a patient's own dendritic cells, has been shown to be safe and effective in generating immune responses against prostate cancer, specifically targeting the prostatic acid phosphatase (PAP) antigen.

In Phase III trials, sipuleucel-T significantly prolonged median survival in patients with castrate-resistant prostate cancer (CRPC), leading to its FDA approval in 2010, although it had minimal impact on disease progression or PSA levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccine therapy with sipuleucel-T (Provenge) for prostate cancer. Thara, E., Dorff, TB., Pinski, JK., et al.[2022]

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]

References

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

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

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 (Provenge) autologous vaccine approved for treatment of men with asymptomatic or minimally symptomatic castrate-resistant metastatic prostate cancer. [2016]

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

Immunotherapy for advanced prostate cancer: a novel treatment option to improve survival. [2016]

5. Germany pubmed.ncbi.nlm.nih.gov

Sipuleucel-T immune parameters correlate with survival: an analysis of the randomized phase 3 clinical trials in men with castration-resistant prostate cancer. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Sipuleucel-T (Provenge): active cellular immunotherapy for advanced prostate cancer. [2010]

7. Ireland pubmed.ncbi.nlm.nih.gov

Vaccine therapy with sipuleucel-T (Provenge) for prostate cancer. [2022]

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

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