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Atezolizumab, Abiraterone, and SBRT in Hormone Sensitive Prostate Cancer

Trial Begins February 10, 2020

Sean McBride, MD

Memorial Sloan Kettering Cancer CenterView Bio

Sean McBride, MD, is a board-certified radiation oncologist with an expertise in treating primary genitourinary (prostate, bladder, kidney, and testicular) and head and neck (oral cavity, base of tongue, tonsil, larynx, hypopharynx, sinus, nasopharynx, and thyroid) malignancies. He works with a dedicated team of medical oncologists, surgeons, and medical physicists to help deliver individualized care using sophisticated radiation therapy techniques including image-guided, stereotactic radiosurgery (IGRT), intensity modulated radiation therapy (IMRT), and brachytherapy.

McBride’s research focuses on clinical trials that combine advanced-technology radiation treatment with targeted and immune therapies in locally advanced and metastatic head and neck and prostate cancer.

Dana Rathkopf, MD

Memorial Sloan Kettering Cancer CenterView Bio

Dana E. Rathkopf, MD, is a board-certified medical oncologist who works as part of a multidisciplinary team to treat people with prostate cancer and other genitourinary cancers. Her primary focus is on the medical treatment of men with advanced or high-risk prostate cancer. She have been doing this work for more than a decade.

Rathkopf also develops and designs clinical trials testing new treatments for her patients. These involve agents that are targeted to androgen receptor (AR) signaling and other molecular pathways that allow the disease to grow and spread. The outlook for men with advanced prostate cancer, also known as castration-resistant prostate cancer (CRPC), has changed dramatically over the past five years thanks to advances in systemic therapies. Drug development has shifted from standard chemotherapy to targeted approaches based on a fundamental understanding of the makeup of the disease biology. One impressive example of the success of this approach was the discovery that androgen receptor overexpression is associated with resistance to conventional anti-androgens. Accompanying this discovery has been the development of AR targeted therapies that block the growth of castration-resistant prostate cancer, such as the AR antagonist enzalutamide (Xtandi®) and the androgen synthesis inhibitor abiraterone acetate (Zytiga®).

Rathkopf has had a leadership role in clinical trials using these next-generation AR targeted therapies for patients with advanced prostate cancer who have not yet received chemotherapy. The survival benefits shown in these trials changed the standard of care for patients. She is now focused on improving outcomes for patients in need by using new AR-directed therapies and combinations of targeted agents.

On a national level, she is the site principal investigator at MSK for the Department of Defense Prostate Cancer Clinical Trials Consortium (PCCTC), an initiative designed to increase patient access to clinical trials across the country. She also serves as co-chair of the American Society of Clinical Oncology Genitourinary Guidelines Advisory Group.

Although she does a lot of work on clinical trials in an effort to bring new and more effective treatment options into clinical practice, her first priority is always her patients. Many of them ask her why I became interested in a disease that affects only men. In addition to her interest in the unique biology of the prostate cancer disease pathway, and the opportunity to work with extraordinary mentors and colleagues, she is also a daughter, wife, and mother of three sons. The choice to pursue a career in prostate cancer was an easy one for her.

View Full Team

Meet the Team:

  • McBride, Sean, MD, Memorial Sloan Kettering Cancer Center
  • Hawley, Jessica, MD, Columbia University Medical Center
  • Rathkopf, Dana, MD, Memorial Sloan Kettering Cancer Center
  • Patient Advocates: Jan Manarite, Joel Nowak
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About This SU2C Catalyst Clinical Trial

Are you or a loved one currently facing prostate cancer? As of 2018, prostate cancer remains the second-leading cause of cancer death among men in the United States. Metastatic hormone-sensitive prostate cancer (mHSPC) is particularly lethal, in part due to lack of effective treatment as the standard-of-care androgen deprivation therapy (ADT) only delays progression of the disease. However, recent clinical evidence has emerged showing that the addition of chemotherapy or the antiandrogen AR targeted therapy acetate (AA) to ADT offers additional survival benefit for mHSPC. Evidence also shows that prostate radiation therapy decreases treatment failure and a type of very high-dose radiation can improve patient’s own immune response via several different biological mechanisms, including enhanced expression of the PD-L1 protein, a target for immune checkpoint inhibitors. Based on these findings the Team expects to capitalize upon the potential synergy between “androgen ablation” (ADT + AR targeted therapy), high-dose radiation and anti-PD-L1 immunotherapy to improve outcomes for mHSPC patients who otherwise would succumb to the disease.

We Need You

Why Your Participation Matters

The demonstration of an improvement in failure-free survival (FFS) with the addition of stereotactic radiation body therapy (SBRT) and atezolizumab to standard-of-care (AR targeted therapy+GnRH analog), if confirmed in a registrational trial, would revolutionize the treatment of metastatic hormone-sensitive prostate cancer by representing the first time that either a local treatment or checkpoint blockade benefited men with metastatic prostate cancer. We will also look to see if SBRT expands activated T-cell phenotypes and results in tumor-specific cytotoxic lymphocytes, confirming critical aspects of the preclinical immunologic benefit of radiotherapy.

Key Insights for Participants

Highlight of any requirements that are misunderstood or likely areas where patients might not comply with trial protocol

Eligibility

Patients with newly diagnosed, metastatic castrate sensitive prostate cancer.

There are additional criteria that must be met to participate, or that may prevent a patient from participating. Key criteria are summarized below and can be found in detail on ClinicalTrials.gov. Interested patients will need to review their medical histories with clinical trial patient coordinators before they can be accepted to participate in this trial.

Gender:
Male
Diagnosis:
Newly diagnosed, metastatic castrate sensitive prostate cancer

Requirements

Biopsy proof of metastatic disease; IPSS ≤ 20

Symptomatic or minimally symptomatic prostate cancer.

M1a/b/c disease (e.g. visceral disease eligible)

Newly diagnosed without prior prostate cancer-directed therapy.

Up to 10 subjects who have prior hormonal therapy within 3 months of signing consents and demonstrate PSA decline are eligible to enroll in Cohort 2.

More +Less -

Acceptable candidate for prostate radiotherapy (e.g. IPSS <20; no inflammatory bowel disease).

Participate

You play a vital role.

Here are the locations where you can participate in this clinical trial. If you or a loved one are interested in enrolling and learning more about this study, please contact the doctor below at your preferred site. They are there to help you understand every aspect of the clinical trial process and can answer any questions you may have.

Once you contact at your preferred location, he or she will start by reviewing your medical history with you to see whether you meet all the criteria to participate. They will then guide you through a review of the study and detailed “informed consent” documents that you are required to sign when you enroll in a clinical trial.

New York - New York

Memorial Sloan Kettering Cancer Center
Contact:
Dana Rathkopf, MD
P: 646-422-4379

Basking Ridge - New Jersey

Memorial Sloan Kettering Cancer Center
Contact:
Dana Rathkopf, MD
P: 646-422-4379

Middletown - New Jersey

Memorial Sloan Kettering Cancer Center
Contact:
Dana Rathkopf, MD
P: 646-422-4379

Montvale - New Jersey

Memorial Sloan Kettering Cancer Center
Contact:
Dana Rathkopf, MD
P: 646-422-4379

New York - New York

Columbia University Medical Center
Contact:
Mark Stein, MD
P: 646-863-5502
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