28 Participants Needed

Combination Therapy for Prostate Cancer

Recruiting at 10 trial locations
DR
SM
Overseen BySean McBride, MD
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
Must be taking: GnRH analogs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is to find out whether adding the study drug atezolizumab and stereotactic body radiotherapy (SBRT) to standard treatment with abiraterone acetate, prednisone, and Lupron® (leuprolide) is a safe and effective way to treat previously untreated metastatic prostate cancer, and to see whether the study treatment works better than the standard treatment.

Will I have to stop taking my current medications?

The trial requires that participants stop taking anti-androgens like bicalutamide (Casodex) before starting the study. Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.

Is the combination therapy for prostate cancer safe for humans?

The combination of abiraterone acetate with prednisone and enzalutamide has been studied for safety in patients with metastatic castration-resistant prostate cancer. These treatments are generally considered safe, but they can have side effects, and their tolerability may vary among individuals.12345

How is the combination therapy of Abiraterone, Atezolizumab, and Enzalutamide unique for prostate cancer?

This combination therapy is unique because it combines Abiraterone and Enzalutamide, which target androgen receptors (proteins that bind male hormones), with Atezolizumab, an immunotherapy drug that helps the immune system attack cancer cells. This approach aims to address resistance mechanisms in prostate cancer by using both hormonal and immune system strategies.14678

What data supports the effectiveness of the drug combination therapy for prostate cancer?

The combination of abiraterone acetate and enzalutamide has been shown to improve outcomes for patients with metastatic prostate cancer when added to androgen deprivation therapy, according to the STAMPEDE trials.34689

Who Is on the Research Team?

DR

Dana Rathkopf, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Men over 18 with untreated metastatic hormone-sensitive prostate cancer, who can consent to treatment and have normal organ function. They must be eligible for SBRT, have an ECOG status of 0 or 1, and agree to use birth control during the study. Exclusions include HIV/HBV/HCV infection, large prostate volume (>80cc), certain allergies, other recent cancers or treatments, uncontrolled conditions like hypertension or infections.

Inclusion Criteria

My prostate cancer was confirmed through a biopsy.
Willing and able to provide or have a legally authorized representative to provide written informed consent and HIPAA authorization for the release of personal health information
Subjects must agree to use a medically acceptable method of birth control or sexual abstinence for the duration of the study, including 150 days after the last dose of study drug
See 5 more

Exclusion Criteria

Treatment with investigational therapy within 28 days prior to initiation of study treatment
I haven't had major heart problems in the last 6 months.
I have brain metastasis or active leptomeningeal disease.
See 26 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with atezolizumab, abiraterone acetate, prednisone, GnRH analog, and SBRT

6 months
Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Abiraterone
  • Atezolizumab
  • Enzalutamide
  • Stereotactic Body Radiotherapy (SBRT)
Trial Overview The trial is testing if adding atezolizumab (an immunotherapy drug) and SBRT to standard treatment with abiraterone acetate (a hormonal therapy), prednisone (a steroid), and Lupron® improves outcomes in men with newly diagnosed metastatic prostate cancer compared to standard treatment alone.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Metastatic Prostate CancerExperimental Treatment7 Interventions

Abiraterone is already approved in United States, European Union, Canada, Japan for the following indications:

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Approved in United States as Zytiga for:
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Approved in European Union as Zytiga for:
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Approved in Canada as Zytiga for:
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Approved in Japan as Zytiga for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Genentech, Inc.

Industry Sponsor

Trials
1,578
Recruited
569,000+
Ashley Magargee profile image

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway profile image

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Stand Up To Cancer

Collaborator

Trials
53
Recruited
40,100+

Published Research Related to This Trial

Combining atezolizumab, an anti-PD-L1 immunotherapy, with enzalutamide, an androgen receptor antagonist, did not improve survival rates in patients with metastatic prostate cancer.
Further research is needed to understand the mechanisms of resistance to immunotherapy in the prostate tumor microenvironment, which may help improve treatment outcomes.
Anti-PD-L1 plus enzalutamide does not improve overall survival in prostate cancer.Siddiqui, BA., Subudhi, SK., Sharma, P.[2023]
In a study involving 1919 patients with metastatic prostate cancer, the addition of abiraterone acetate to standard androgen deprivation therapy significantly improved overall survival, with a median survival of 76.6 months compared to 45.7 months for standard care alone.
Combining both abiraterone and enzalutamide did not provide additional survival benefits over abiraterone alone, and it was associated with higher rates of severe side effects, suggesting that this combination should be avoided in long-term treatment plans.
Abiraterone acetate plus prednisolone with or without enzalutamide for patients with metastatic prostate cancer starting androgen deprivation therapy: final results from two randomised phase 3 trials of the STAMPEDE platform protocol.Attard, G., Murphy, L., Clarke, NW., et al.[2023]
In a study of 133 patients with non-metastatic castration-resistant prostate cancer, abiraterone acetate (AA) plus prednisone showed comparable overall survival and cancer-specific survival to enzalutamide (Enz) over a median follow-up of 36 months.
However, patients treated with AA plus prednisone had a significantly higher risk of non-cancer-caused death compared to those treated with Enz, suggesting that while both treatments are effective, AA plus prednisone may pose additional safety concerns.
Real-world survival outcome comparing abiraterone acetate plus prednisone and enzalutamide for nonmetastatic castration-resistant prostate cancer.Tsujino, T., Tokushige, S., Komura, K., et al.[2023]

Citations

Anti-PD-L1 plus enzalutamide does not improve overall survival in prostate cancer. [2023]
Abiraterone acetate plus prednisolone with or without enzalutamide for patients with metastatic prostate cancer starting androgen deprivation therapy: final results from two randomised phase 3 trials of the STAMPEDE platform protocol. [2023]
Real-world survival outcome comparing abiraterone acetate plus prednisone and enzalutamide for nonmetastatic castration-resistant prostate cancer. [2023]
Results of a Real-world Study of Enzalutamide and Abiraterone Acetate With Prednisone Tolerability (REAAcT). [2021]
Cabozantinib in combination with atezolizumab in patients with metastatic castration-resistant prostate cancer: results from an expansion cohort of a multicentre, open-label, phase 1b trial (COSMIC-021). [2022]
Abiraterone acetate: a guide to its use in metastatic castration-resistant prostate cancer. [2021]
Managing lines of therapy in castration-resistant prostate cancer: real-life snapshot from a multicenter cohort. [2021]
Abiraterone acetate in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer: U.S. Food and Drug Administration drug approval summary. [2018]
Identification of mechanisms of resistance to treatment with abiraterone acetate or enzalutamide in patients with castration-resistant prostate cancer (CRPC). [2021]
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