February 18, 2022:

Big Ten Cancer Research Consortium investigators presented a Trial in Progress abstract at the 2022 American Society of Clinical Oncology Genitourinary Cancer Symposium. The abstract titled, A single arm, phase I/II trial of neoadjuvant androgen deprivation, darolutamide, and ipatasertib in men with localized, high-risk prostate cancer, is led by David J VanderWeele, MD, PhD of the Robert H Lurie Comprehensive Cancer Center of Northwestern University.

Most patients who die of prostate cancer had potentially curable localized disease when first diagnosed, but their cancer subsequently relapsed to an incurable state. Neoadjuvant intense androgen deprivation therapy (ADT) has led to exceptional pathologic responses in up to 30% of patients with intermediate or high-risk localized disease, with evidence of longer-term clinical benefit. Prostate cancers with loss of the tumor suppressor gene PTEN, however, are resistant to neoadjuvant therapy that only targets the Androgen Receptor. Ipatasertib has shown efficacy in metastatic castration resistant prostate cancer (mCRPC), especially in patients with tumors that lack PTEN.

The primary objective of this study is to estimate the efficacy of neoadjuvant androgen deprivation, darolutamide, and ipatasertib in men with previously untreated, localized, high-risk prostate cancer that is lacking PTEN, as measured by the pathological complete response or minimal residual disease. Secondary objectives of the BTCRC GU19-404 study are to assess the toxicity profile of androgen deprivation, darolutamide, and ipatasertib in men with high risk, localized, hormone sensitive prostate cancer that is lacking PTEN, to measure 2 year biochemical recurrence-free survival (PSA </=0.2 ng/mL) in men with high risk, localized, prostate cancer that is lacking PTEN and to estimate rate of PSA0 (undetectable PSA with testosterone recovery and no additional therapy) in men with high risk, localized, prostate cancer that is lacking PTEN.

View the abstract

Authors include: David James VanderWeele, Sarah Elizabeth Fenton, Gregory Auffenberg, Borko Jovanovic, Maha H. A. Hussain

Participating institutions of this study include Lurie Cancer Institute of Northwestern University and Indiana University Melvin and Bren Simon Comprehensive Cancer Center.

About the Big Ten Cancer Research Consortium: The Big Ten Cancer Research Consortium was created in 2013 to transform the conduct of cancer research through collaborative, hypothesis-driven, highly translational oncology trials that leverage the scientific and clinical expertise of Big Ten universities. The goal of the Big Ten Cancer Research Consortium is to create a unique team-research culture to drive science rapidly from ideas to new approaches to cancer treatment. Within this innovative environment, today’s research leaders collaborate with and mentor the research leaders of tomorrow with the unified goal of improving the lives of all patients with cancer.

About the Big Ten Conference: The Big Ten Conference is an association of world-class universities whose member institutions share a common mission of research, graduate, professional and undergraduate teaching and public service. Founded in 1896, the Big Ten has sustained a comprehensive set of shared practices and policies that enforce the priority of academics in the lives of students competing in intercollegiate athletics and emphasize the values of integrity, fairness and competitiveness. The broad-based programs of the 14 Big Ten institutions will provide over $200 million in direct financial support to more than 9,800 students for more than 11,000 participation opportunities on 350 teams in 42 different sports. The Big Ten sponsors 28 official conference sports, 14 for men and 14 for women, including the addition of men’s ice hockey and men’s and women’s lacrosse since 2013. For more information, visit www.bigten.org