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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to combat prostate cancer that has spread and no longer responds to hormone therapy. It involves an extended course of Sipuleucel-T, a type of immunotherapy designed to enhance the body's natural defenses against cancer cells. Men with prostate cancer that has spread and who experience little or no symptoms may be suitable for this trial. The goal is to determine if a longer treatment course can strengthen the immune response and improve therapy effectiveness. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that Sipuleucel-T is usually well-tolerated by patients. In past studies, serious side effects were uncommon, with the treatment most often causing mild reactions like fever, tiredness, or chills.

After the treatment became publicly available, further analysis found that Sipuleucel-T rarely caused major health changes, suggesting the treatment is quite safe. Additionally, many patients who received Sipuleucel-T lived longer than those who did not.

Since this trial is in an early stage, it primarily focuses on understanding the treatment's safety. Although Sipuleucel-T is already approved for prostate cancer, this trial tests a longer course of the treatment. Early studies generally look for any safety concerns, so researchers closely monitor participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for prostate cancer, which often include hormone therapy, radiation, or chemotherapy, Sipuleucel-T is unique because it's a form of cellular immunotherapy. It works by stimulating the body's own immune system to target and attack prostate cancer cells. This personalized approach involves collecting and modifying a patient's immune cells before infusing them back into the body, which is different from traditional methods that directly target the cancer cells themselves. Researchers are excited about Sipuleucel-T because it offers a new way to enhance the body's natural defenses against cancer, potentially leading to more effective and longer-lasting treatment outcomes.

What evidence suggests that this treatment might be an effective treatment for metastatic Castration-Resistant Prostate Cancer?

Research shows that sipuleucel-T, the treatment under study in this trial, can extend the lives of men with advanced prostate cancer. Studies found that patients treated with sipuleucel-T had a 28% lower risk of death. In one study, these patients had a 33% lower chance of dying compared to those who didn't receive the treatment. Additionally, nearly 38% more men who received sipuleucel-T were alive three years later compared to those who did not. This evidence suggests that sipuleucel-T effectively helps people with this type of prostate cancer live longer. ^{3 4 6 7 8}

Who Is on the Research Team?

Kelly Stratton, MD

Principal Investigator

Investigator

Are You a Good Fit for This Trial?

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

Life expectancy of ≥ 6 months

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

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or GM-CSF

I have previously received Provenge® treatment.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 (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 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, 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9123060/

Real-World Effectiveness of Sipuleucel-T on Overall Survival ... This represents a 28% reduced risk of death with sipuleucel-T (hazard ratio 0.717 [95% CI 0.648, 0.793]; p < 0.01) based on a multivariate Cox ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa1001294

Sipuleucel-T Immunotherapy for Castration-Resistant ... The use of sipuleucel-T prolonged overall survival among men with metastatic castration-resistant prostate cancer. No effect on the time to ...

3. provenge.com provenge.com/hcp/prolonged-survival/

Prolonged Survival | HCP Nearly 38% more men who received PROVENGE were still alive 3 years post treatment compared to control.1,b. b This information is data on file and represents an ...

4. aetna.com aetna.com/cpb/medical/data/800_899/0802.html

Sipuleucel-T (Provenge) - Medical Clinical Policy Bulletins In the integrated analysis of D9901 and D9902A, patients randomized to sipuleucel-T demonstrated a 33 % reduction in the risk of death (HR, 1.50; 95 % CI: 1.10 ...

5. urotoday.com urotoday.com/library-resources/mcrpc-treatment/120724-contemporary-update-on-sipuleucel-t-for-men-with-metastatic-castrate-resistant-prostate-cancer.html

A Contemporary Update on Sipuleucel-T for Men with ... The IMPACT study demonstrated that treatment with sipuleucel-T was associated with approximately 20% improved overall survival (hazard ratio 0.78, 95% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6856402/

Real‐world outcomes of sipuleucel‐T treatment in PROCEED ... Among the 1255 patients who died, 964 (76.8%) died of prostate cancer (PC) progression. The median time from the first infusion to PC death was 42.7 months (95% ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31483485/

Real-world outcomes of sipuleucel-T treatment in PROCEED ... Among the 1255 patients who died, 964 (76.8%) died of prostate cancer (PC) progression. The median time from the first infusion to PC death was ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2747749

Postmarketing Analysis of Sipuleucel-T Although an overall survival benefit was seen in clinical trials, sipuleucel-T treatment is rarely associated with significant changes in ...