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New Prostate Cancer Clinical Trials Seek to Advance Outcomes with Novel Treatment Approaches for High-risk Cases

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Prostate cancer is the most common cancer among men, except for skin cancer. This year, an estimated 174,650 men in the United States will be diagnosed with prostate cancer, and approximately 60% of cases are diagnosed in men over 65. The average age of diagnosis is 66, and the disease rarely occurs before age 40.

Prostate cancer defined as “high-risk” accounts for approximately 15 percent of newly diagnosed prostate cancers. Several definitions of high-risk prostate cancer are used in the urological literature. Patients with high-risk localized or locally advanced prostate cancer include those with Gleason scores ≥8, clinical stage ≥cT2c (disease in both or extension outside of the lobes), high baseline prostate-specific antigen (PSA; ≥20 ng/mL), or involvement of regional nodes.

Our clinical research program currently has the following three trials open which are seeking to advance outcomes with novel treatment approaches:

56021927PCR3011: A Randomized, Double-blind, Placebo-controlled Phase III Study of Apalutamide in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Primary objective is to determine if treatment with androgen deprivation therapy (ADT) plus apalutamide (with or without abiraterone acetate and prednisone/AAP) before and after radical prostatectomy in subjects with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS), as compared to ADT plus placebo. This study is designed to evaluate if androgen blockade administered prior to and after radical prostatectomy will increase the rate of pCR and lead to better overall outcomes.

GU002: Phase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy with or without Adjuvant Docetaxel

Primary objective is to assess the benefit of docetaxel as measured by improvement in freedom from progression (Phase II) and subsequently metastasis free survival (Phase III) when given in combination with radiation and androgen deprivation in treatment of high-risk prostate cancer post-radical prostatectomy.

GU006: A Phase II, Double-blinded, Placebo-controlled Randomized Trial of Salvage Radiotherapy with or without Enhanced Anti-androgen Therapy with Apalutamide in Recurrent Prostate Cancer

Primary objective is to determine whether, in men with post-prostatectomy prostate-specific antigen (PSA) recurrences, salvage radiation (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone. A bPFS event is defined as a rise in PSA > 0.2 ng/mL from nadir, confirmed by a second PSA measurement; clinical or radiographic local, regional, or distant metastases; or death from any cause, whichever occurs first. The precise standard of care for men with a rising PSA post-prostatectomy is controversial and unclear. This Phase II trial is also designed to determine if a molecular biomarker, which stratifies prostate cancers by luminal versus basal subtypes, can predict response to apalutamide, a novel, next-generation nonsteroidal anti-androgen in advanced clinical testing. If the biomarker is found to be predictive of treatment response, it would then be used for patient selection in the follow-up Phase III trial.

Please contact our Clinical Trials Office at Call407-303-2090 or email [email protected] for additional information about any of our clinical research studies.


The following physicians at AdventHealth Cancer Institute serve as clinical trial investigators:

Asim Aijaz, MD

Adnan Akhtar, MD

Matthew Albert MD

Carlos Alemañy, MD

Heather Allewelt, MD

J. Pablo Arnoletti, MD

Dennis Borrero, MD

Jeffrey Brady, MD

Raul Castillo, MD

Jeff Chang, MD

Afshin Forouzannia, MD

Steven Goldstein, MD

Fouad Hajjar, MD

Mark Harvey, MD

Bruce Haughey, MD

Charles Hodge, MD

Robert Holloway, MD

Catherine Hwang, MD

Olga Ivanov, MD

Susan Kelly, MD

James Kendrick, MD

Qamar Khan, MD

Scott Magnuson, MD

Sherif Makar, MD

Nathalie McKenzie, MD

Tarek Mekhail, MD

John Monson. MD

Shahram Mori, MD

Rakesh Patel, MD

Rushang Patel, MD

Inoel Rivera, MD

Kunal Saigal, MD

Samir Sejpal, MD

David Shook, MD

Ravi Shridhar, MD

Mark Socinski, MD

Ahmed Zakari, MD

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