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Written by Rashid K. Sayyid, MD MSc University of Southern California Los Angeles, CA & Zachary Klaassen, MD MSc Wellstar MCG Health Augusta, GA
November 4, 2024
In November 2023, the United States Food and Drug Administration (FDA) approved enzalutamide, with or without concurrent leuprolide therapy, for conventional imaging-defined non-metastatic hormone-sensitive prostate cancer (M0 HSPC) patients with biochemical recurrence at high risk for metastasis.
Written by Rashid Sayyid, MD MSc, & Zachary Klaassen, MD MSc
October 19, 2022
Although definitive local therapy in the form of radical prostatectomy or radiation therapy with or without ADT offers excellent long-term outcomes for the majority of patients with clinically localized prostate cancer, patients with high-risk disease experience primary treatment failure rates approaching 65%.1 Disease persistence/recurrence in such patients may be restricted to the prostatic fossa
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Presented by James Kearns, MD
The 2026 American Urologic Association (AUA) Annual Meeting was host to a prostate cancer clinical trials-in-progress session. Dr. James Kearns presented AMPLIFY, an ongoing phase III trial of 64Cu-SAR-bisPSMA positron emission tomography (PET) in biochemically recurrent prostate cancer patients.
Presented by Neal D. Shore, MD, FACS
The 2024 ESMO annual meeting included a session on prostate cancer, featuring a presentation by Dr. Neal Shore discussing a post hoc analysis from EMBARK focusing on age.
Publications
Peer-Reviewed Journal Abstracts

We investigated the real-world criteria and thresholds physicians use to classify patients with nonmetastatic castration-sensitive prostate cancer with biochemical recurrence as high risk, and how these align with guidelines.

This podcast features two of the investigators from the phase III EMBARK trial (NCT02319837) in conversation. The primary results from EMBARK demonstrated meaningfully improved primary and key secondary efficacy outcomes, while maintaining quality of life, with enzalutamide with or without leuprolide versus leuprolide alone in patients with high-risk biochemically recurrent prostate cancer.

Biochemical recurrence (BCR) after radical prostatectomy occurs in up to one-third of patients and increases the risk of metastasis and prostate cancer-specific mortality. While androgen deprivation therapy (ADT) remains a foundational approach, its routine use in low- and intermediate-risk BCR raises concerns regarding overtreatment and long-term quality-of-life (QOL) impairment.

The primary analysis of EMBARK reported improved metastasis-free survival for enzalutamide plus leuprolide (enzalutamide combination) vs leuprolide plus placebo (leuprolide alone) in patients with high-risk biochemical recurrence (BCR) while maintaining quality of life.

The EMBARK trial demonstrated that enzalutamide ± leuprolide significantly improved metastasis-free survival (MFS) in patients with nonmetastatic castration-sensitive prostate cancer with high-risk biochemical recurrence (hrBCR).

The natural history of biochemical recurrence (BCR) is highly variable, complicating the distinction between BCR and metastasis. A targeted approach to risk stratifying disease progression is needed.

High-risk biochemical recurrence (BCR) definition varies across clinical studies/practice guidelines. We evaluated metastasis-free survival (MFS) by blinded, independent, central review and safety in EMBARK (NCT02319837) patients defined as high-risk BCR per European Association of Urology (EAU) criteria.

We evaluate unique clinical and drug development challenges in biochemically recurrent (BCR) prostate cancer. We examine risk stratification, critically appraise trials, and outline ongoing and future development of hormonal and non-hormonal options.

The natural history of biochemical recurrence (BCR) managed with delayed hormonal therapy is well documented by data from Johns Hopkins. However, as many patients receive treatment prior to metastasis, we evaluated the natural history and role of prostate-specific antigen doubling time (PSADT) in a more contemporary cohort of BCR patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC).

The summary presented herein covers recommendations on salvage therapy for recurrent prostate cancer intended to facilitate care decisions and aid clinicians in caring for patients who have experienced a recurrence following prior treatment with curative intent.

The summary presented herein covers recommendations on salvage therapy for recurrent prostate cancer intended to facilitate care decisions and aid clinicians in caring for patients who have experienced a recurrence following prior treatment with curative intent.

Biochemical recurrence (BCR) occurs in 20-50% of patients with prostate cancer (PCa) undergoing primary definitive treatment. Patients with high-risk BCR have an increased risk of metastatic progression and subsequent PCa-specific mortality, and thus could benefit from treatment intensification.

Prostate-specific membrane antigen (PSMA) PET is highly sensitive in identifying disease recurrence in men with biochemical recurrence of prostate cancer (BCR) after primary therapy and is rapidly being adopted in clinical practice.

To compare local/metastatic disease progression and overall mortality rates in men with node-negative prostate cancer at radical prostatectomy (RP) that experience biochemical recurrence vs. persistence postoperatively and undergo salvage radiation therapy (sRT).

To develop a model predicting the probability of detecting prostate cancer (PCa) recurrence outside the prostatic fossa on PSMA PET/CT in patients with biochemical recurrence (BCR) after radical prostatectomy (RP).

Overview on the use of androgen deprivation therapy (ADT) added to salvage radiation therapy (SRT) for prostate cancer patients with biochemical recurrence after prostatectomy.

The German Society of Radiation Oncology (DEGRO) expert panel summarized available evidence published between January 2009 and May 2017, and assessed the validity of the information on outcome parameters including overall survival (OS) and treatment-related toxicity.

Press Releases
Official Announcements on Clinical Developments
  • XTANDI: the first and only androgen receptor inhibitor-based regimen to demonstrate overall survival benefit in non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR)
Reno, Nevada (UroToday.com) -- Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") announced positive topline results from the overall survival (OS) analysis from the Phase 3 EMBARK study evaluating XTANDI® (enzalutamide), in combination with leuprolide and as a monotherapy, in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as nonmetastatic castration-sensitive prostate cancer or nmCSPC) with biochemical recurrence (BCR) at high risk for metastasis.