Eric Klein, MD, chairman of the Glickman Urological & Kidney Institute, as well as a staff member at the Taussig Cancer Institute, Cleveland Clinic, discusses safety data with VERU-111 from a phase 2 trial (NCT03752099) that enrolled patients with metastatic castration-resistant prostate cancer (mCRPC) that was presented during the 2021 Genitourinary Cancers Symposium.

The goal of the study was to establish a maximum-tolerated dose of VERU-111 in patients with mCRPC, as well evaluate the safety of the agent, Klein explains. The agent demonstrated favorable tolerability in the 39 patients enrolled in the phase 1b portion of the study, Klein notes. Moreover, these findings will serve as the basis for the upcoming phase 3 trial.

VERU-111 appears to be a promising agent, as prostate cancer is sensitive to agents that target the microtubule-mitotic mechanism, Klein says. This is known because other agents in the space, such as docetaxel and cabazitaxel, have been approved by the FDA for use in patients with mCRPC. The agents have been shown to reduce disease burden, Klein says. VERU-111 shows promise because it will be easier to administer with fewer adverse effects, Klein concludes.

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Eric Klein, MD, discusses safety data with VERU-111 from a phase 2 trial that enrolled patients with metastatic castration-resistant prostate cancer that was presented during the 2021 Genitourinary Cancers Symposium.


Dr. Klein on the Safety of VERU-111 in mCRPC

Eric A. Klein, MD, chairman of the Glickman Urological & Kidney Institute and staff member in the Taussig Cancer Institute at Cleveland Clinic, discusses challenges with active surveillance in prostate cancer.

When looking at a study conducted at John Hopkins, one of the leaders in recommending active surveillance to patients a few decades ago, investigators followed a group of 1000 patients for a total of 15 years. Notably, the patients did very well and very few deaths were reported, Klein adds.

However, patients had to get a biopsy every year, for all 15 years. Biopsies are not easy for patients, Klein explains. Moreover, several risks are associated with biopsies such as bacteremia and sepsis, and in the past, even occasional deaths have been reported, Klein concludes.

Eric A. Klein, MD, discusses challenges with active surveillance in prostate cancer.

Dr. Klein on Challenges With Active Surveillance in Prostate Cancer

Eric A. Klein, MD, professor, Department of Surgery, School of Medicine, member, GU Malignancies Program, Case Comprehensive Cancer Center, Case Western Reserve University, chairman, Glickman Urological & Kidney Institute, Taussig Cancer Institute, Cleveland Clinic, discusses the Oncotype DX test and how it is utilized to predict tumor aggressiveness in patients with prostate cancer. 

Oncotype DX is a tumor profiling test that measures a group of 17 genes, determining the aggressiveness of the prostate cancer. Investigators have discovered that this form of genomic testing can predict the likelihood of developing prostate cancer or passing away from the metastatic disease later on in life, says Klein. 

The Oncotype DX test is intended to be used in patients who are considering active surveillance, a safe management approach for early-stage, low-grade prostate cancer, says Klein. Active surveillance involves finding the right patient with the right tumor biology and instead of subjecting them to treatment and associated adverse events, closely monitoring them instead. Patients are typically revaluated every 6 months with a digital rectal exam and a prostate-specific antigen test, and once a year, an MRI of the prostate as well as another prostate biopsy, says Klein.

These tests, when done on an initial or subsequent biopsy can help determine whether a tumor has become more aggressive and which patients should receive active surveillance versus immediate intervention. Results showing a high score can indicate higher grade cancer that would call for treatment; that’s how the test should be utilized in this population, concludes Klein.

Eric A. Klein, MD, discusses the Oncotype DX test and how it is utilized to predict tumor aggressiveness in patients with prostate cancer. 

Dr. Klein on Predicting Tumor Aggressiveness With Oncotype DX Test in Prostate Cancer

Eric A. Klein, MD, professor, Department of Surgery, School of Medicine, member, GU Malignancies Program, Case Comprehensive Cancer Center, Case Western Reserve University, chairman, Glickman Urological & Kidney Institute, Taussig Cancer Institute, Cleveland Clinic, discusses the utility of Oncotype DX Genomic Prostate Score in predicting outcomes in African American men with prostate cancer.

Oncotype DX is a test that is on the market which measures the expression of 17 genes off of a biopsy to help determine the aggressiveness of the prostate cancer, says Klein. Investigators have shown that the test  can also predict the likelihood of developing metastatic disease or dying from prostate cancer 20 years out, says Klein. Oncotype DX has been on the market for several years now.

One group of investigators examined whether the test performed equally well in Caucasian American men versus those who were African American, which is important because the latter are at a higher risk of developing prostate cancer, explains Klein. The goal of the research was to learn whether this particular tool was useful in determining tumor aggressiveness. Results showed that the test was effective in that regard, adds Klein. In both cohorts, the test was found to have performed equally well and that should provide reassurance that self-identified race is not an important consideration when using this test, says Klein. One can have confidence in the test's utility in all groups of men, concludes Klein.

Eric A. Klein, MD, discusses the utility of Oncotype DX Genomic Prostate Score in predicting outcomes in African American men with prostate cancer.

Dr. Klein on Oncotype DX in Predicting Outcomes in African Americans With Prostate Cancer

Eric A. Klein, MD, professor, Department of Surgery, School of Medicine, member, GU Malignancies Program, Case Comprehensive Cancer Center, Case Western Reserve University, chairman, Glickman Urological & Kidney Institute, Taussig Cancer Institute, Cleveland Clinic, discusses the importance of providing genomic testing to patients with prostate cancer.

Genomic testing can offer crucial insight into a patient’s disease, says Klein. Moreover, results of genotyping can inform treatment selection.

For example, on May 15, 2020, the FDA granted an accelerated approval to the PARP inhibitor rucaparib (Rubraca) for the treatment of men with metastatic castration-resistant prostate cancer that is associated with a germline or somatic 

 mutation who have been treated with androgen receptor—directed therapy and taxane-based chemotherapy.

Providing genomic testing can inform the molecular aggressiveness of early-stage prostate cancer, help determine which patients should receive active surveillance versus immediate intervention, identify patients with high-risk cancer, and determine which patients are likely to benefit from early radiation after radical prostatectomy, concludes Klein.

Eric A. Klein, MD, discusses the importance of providing genomic testing to patients with prostate cancer.

Eric A. Klein, MD

Articles

Dr. Klein on the Safety of VERU-111 in mCRPC

Dr. Klein on Challenges With Active Surveillance in Prostate Cancer

Dr. Klein on Predicting Tumor Aggressiveness With Oncotype DX Test in Prostate Cancer

Dr. Klein on Oncotype DX in Predicting Outcomes in African Americans With Prostate Cancer

Dr. Klein on the Importance of the Importance of Prognostic Genomic Assays in Prostate Cancer