Sipuleucel-T for Prostate Cancer

(ProvONE Trial)

Recruiting at 30 trial locations

Overseen By Margaret Warner-Lubin

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Dendreon

Must be taking: PROVENGE

Must not be taking: Immunosuppressants, Steroids, Vaccinations, others

Disqualifiers: Infections, Psychiatric illness, 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

Compensation: Varies

Number of Visits: 1

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how a booster dose of Sipuleucel-T, a type of immunotherapy, might enhance the immune response in men with metastatic castrate-resistant prostate cancer. The study compares two groups: one receiving the booster dose and one without additional treatment after the standard Provenge therapy. Men who have completed three infusions of Provenge and have minimal or no symptoms from their prostate cancer are likely suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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 be on certain treatments like chronic immunosuppressive therapy or experimental therapies. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that Sipuleucel-T is likely to be safe for humans?

Research has shown that sipuleucel-T is generally safe for people. After its public release, no new or unexpected side effects emerged, indicating no surprising or harmful reactions. Real-world studies also demonstrate that patients tolerate sipuleucel-T well.

This treatment has been used in men with advanced prostate cancer that does not respond to hormone therapy. It works by helping the immune system fight cancer. Studies have shown that sipuleucel-T can lower the risk of dying from prostate cancer, suggesting it can be an effective and safe option for patients.

Overall, while every treatment can have side effects, sipuleucel-T has maintained a strong safety record in past studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Unlike the standard treatments for prostate cancer, which often include hormone therapy, chemotherapy, and radiation, Sipuleucel-T offers a unique approach by harnessing the body's immune system. It is an autologous cellular immunotherapy, meaning it uses a patient's own immune cells to target and attack cancer cells, which is different from traditional treatments that directly target the tumor itself. Researchers are excited about Sipuleucel-T because it represents a personalized treatment strategy, potentially leading to fewer side effects and a new way to extend survival in patients with advanced prostate cancer.

What evidence suggests that Sipuleucel-T might be an effective treatment for prostate cancer?

Research has shown that sipuleucel-T can extend the lives of men with advanced prostate cancer. In one study, it reduced the risk of death by 28% compared to those who did not receive the treatment. Additionally, nearly 38% more men were alive three years after receiving sipuleucel-T than those who did not. This treatment aids the body's immune system in fighting cancer cells. Although it does not slow the cancer's growth, it has been proven to prolong patients' lives. Participants in this trial may receive a single infusion of sipuleucel-T as part of the Booster Arm, while others will be in the No Booster control arm. ^{2 3 4 6 7}

Who Is on the Research Team?

Nadeem Sheikh, PhD

Principal Investigator

Dendreon Pharmaceuticals, LLC

Benjamin Lowentritt, MD

Principal Investigator

Chesapeake Urology

Are You a Good Fit for This Trial?

This trial is for individuals with advanced prostate cancer that no longer responds to hormone therapy (mCRPC). Participants must have completed all 3 infusions of PROVENGE® before joining, be expected to live at least another year, and give written consent.

Inclusion Criteria

You have agreed in writing to take part in the study before it starts.

You are expected to live for at least 12 more months.

I am eligible for PROVENGE® treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive commercial PROVENGE® immunotherapy

6-9 months

Booster Treatment

Participants receive a single booster infusion of sipuleucel-T

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, immune response, and overall survival

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Sipuleucel-T

Trial Overview The study is testing the effects of an additional infusion of Sipuleucel-T in patients who have already received the standard treatment with PROVENGE®. It's a multicenter study observing how this extra dose might change immune responses.

How Is the Trial Designed?

Group I: Booster Arm Experimental Treatment 1 Intervention

Experimental: Treatment Group: Single Infusion of Sipuleucel-T (Booster) Sipuleucel-T is an autologous cellular immunotherapy available as a suspension for intravenous infusion. Subjects randomized to sipuleucel-T arm will receive 1 infusion of sipuleucel-T 6-9 months after receiving commercial Provenge. These subjects will be followed as described in the schedule of events.

Group II: No Booster Active Control 1 Intervention

No Intervention: Control Arm Subjects randomized to the control arm after receiving commercial Provenge will be followed as described in the schedule of events.

Who Is Running the Clinical Trial?

Dendreon

Lead Sponsor

Trials

30

Recruited

5,200+

WCG IRB

Collaborator

Trials

2

Recruited

1,000+

Talosix

Collaborator

Trials

3

Recruited

640+

Citations

1. 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 ...

2. 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 ...

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35352309/

Real-World Effectiveness of Sipuleucel-T on Overall ... This real-world study of mCRPC treatment indicates that men receiving sipuleucel T and an ARTA survive longer than men who only receive an ARTA, ...

5. 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 ...

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. 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% ...