ADT Heads List of Therapies in New Prostate Ca Guide

Editor’s note: The American American Society of Clinical Oncology (ASCO) and Cancer Care Ontario (CCO) have jointly published a new guideline for treating metastatic castration-resistant prostate cancer (mCRPC). The guideline says that androgen deprivation therapy (ADT) should be the foundation of treatment, and should be given along with certain drugs. The guideline specifies which kinds of patients should receive which drugs, in addition to ADT.

“Indefinite continuation of androgen deprivation therapy (ADT) remains the cornerstone of systemic treatment for metastatic castration-resistant prostate cancer (mCRPC), augmented by new agents, according to a joint guideline from American and Canadian oncology groups.

“In addition to ADT (medical or surgical), clinicians should offer patients with mCRPC abiraterone (Zytiga) plus prednisone, enzalutamide (Xtandi), and radium-223 (Xofigo), all of which have favorable benefit-harm profiles, the guideline indicated. Patients also may be offered docetaxel plus prednisone, but should be thoroughly informed of potential toxicity.

“Other systemic agents have niche roles in the treatment of mCRPC, as recommended by the American Society of Clinical Oncology (ASCO) and Cancer Care Ontario (CCO). The guideline was published online in the Journal of Clinical Oncology and is available on the ASCO website.”

Enzalutamide Improved Health-Related Quality of Life in Prostate Cancer

Editor’s note: This article discusses the results of a clinical trial—a research study with volunteer patients. All patients who participated in the trial had metastatic castration-resistant prostate cancer that had worsened during treatment with the chemotherapy drug docetaxel. The study found that treatment with the drug enzalutamide reduced symptoms and improved quality of life for the patients.

“Enzalutamide was associated with significant improvements in disease-related symptoms and all aspects of health-related quality of life among men with metastatic castration-resistant prostate cancer, according to results of the phase 3, double blind AFFIRM trial.

“The trial included 1,199 patients who progressed during treatment with docetaxel.

Karim Fizazi, MD, PhD, medical oncologist in the department of cancer medicine at Institut Gustave Roussy at the University of Paris, and colleagues randomly assigned 800 patients to 160 mg daily enzalutamide (Xtandi; Astellas, Medivation). The other 399 patients received placebo.”

Investigational Prostate Cancer Drug Decreased PSA Levels with Low Toxicity

The gist: Researchers conducted a clinical trial with volunteer patients to test a new drug for nonmetastatic castration-resistant prostate cancer. Patients participating in the trial were treated with the drug orteronel. It was found that orteronel decreased PSA levels (high PSA levels may correlate with worsening disease).

“Monotherapy with the investigational agent orteronel decreased PSA levels in patients with nonmetastatic castration-resistant prostate cancer, according to results of a phase 2 study.

“Toxicities were moderate and manageable, and administration of the drug without steroids appeared to be feasible, Maha Hussain, MD, FACP, professor of medicine and urology at the University of Michigan Comprehensive Cancer Center, and colleagues wrote.”

New Androgen Receptor Inhibitor Shows Activity in Metastatic Castration-Resistant Prostate Cancer

The gist: Some patients have what is known as metastatic “castration-resistant” prostate cancer (mCRPC)—metastatic cancer that worsens despite treatment with traditional hormone therapy. Researchers are hard at work to discover solutions for these treatment-resistant cancers. A recent clinical trial with volunteer mCRPC patients tested a new treatment called ODM-201. The treatment appeared to be safe, and men who took it had promising decreases in their PSA levels. Further testing is needed to see how effective ODM-201 might be in treating mCRPC.

“ODM-201 is a novel androgen receptor inhibitor—structurally distinct from enzalutamide (Xtandi)—that acts via high-affinity binding to the androgen receptor and inhibition of receptor nuclear translocation. In the phase I/II ARADES trial reported in The Lancet Oncology, Fizazi et al identified no maximum tolerated dose and observed prostate-specific antigen (PSA) responses in men with progressive metastatic castration-resistant prostate cancer…

“In this study, conducted in 23 U.S. and European hospitals, no dose-limiting toxicity or maximum tolerated dose was found at an oral ODM-201 dose range of 200 mg to 1,800 mg daily in the phase I portion.  In the phase II portion, 110 patients were randomly assigned to receive doses of 200 mg (n =38), 400 mg (n = 37), or 1,400 mg (n = 35); four, seven, and three patients treated at these dose levels in the phase I portion were also advanced to phase II evaluation. The primary endpoint was ≥ 50% reduction in serum PSA at week 12…

“Among evaluable patients, PSA response at 12 weeks was observed in 29% at 200 mg, 33% at 400 mg, and 33% at 1,400 mg. Response rates were higher among patients who were chemotherapy-naive and had not received CYP17 inhibitor treatment (50%, 69%, and 86%). Follow-up is ongoing.”

ASCO 2014 — Takeaways for Prostate Cancer Patients

Every year, thousands of people gather for the American Society of Clinical Oncology (ASCO) Annual Meeting. This year’s meeting took place in Chicago, Illinois. Here are some of the most notable new developments in prostate cancer treatment presented at ASCO 2014: Continue reading…

Takeda Announces Termination of Orteronel (TAK-700) Development for Prostate Cancer in Japan, U.S.A. and Europe

“Takeda Pharmaceutical Company Limited announced today that it has voluntarily decided to end the development program for orteronel (TAK-700) for prostate cancer. The decision follows the results of two Phase 3 clinical trials in metastatic, castration resistant prostate cancer (mCRPC). The studies found while orteronel plus prednisone could extend the time patients lived before their cancer progressed, it did not extend overall survival in these patients. After careful consideration of the data from these trials, the company has determined that the drug has not demonstrated a clinical profile sufficient to move forward in mCRPC, given the availability of other therapies.”

Editor’s note: Orteronel is a drug that showed some promise in for treating metastatic castration-resistant prostate cancer (mCRPC). However, the manufacturers of the drug found that it was not good enough compared to other treatments, and they have decided to stop developing it. We recently posted a news story in which orteronel showed mixed results as a treatment for mCRPC.

Early Trial of Cabozantinib and Abiraterone Shows Promise in Prostate Cancer

“A phase I trial that combined the investigational therapy cabozantinib with the already approved abiraterone acetate in metastatic castration-resistant prostate cancer (CRPC) patients shows that the two agents are tolerable, with the potential for improved efficacy.

“Christopher Sweeney, MBBS, medical oncologist at Dana-Farber Cancer Institute in Boston, presented the results (abstract #5027) at the American Society of Clinical Oncology Annual Meeting, held May 30–June 3 in Chicago.”

Editor’s note: A clinical trial to test a new treatment on volunteer patients found that a combination of the drugs cabozantinib and abiraterone acetate may be beneficial for treating metastatic castration-resistant prostate cancer (CRPC), but further testing is needed.

ASCO: Drug Combo Highly Active in Metastatic CRPC

“A small cohort of men with untreated metastatic castration-resistant prostate cancer (CRPC) had a PSA response rate of 86% with the combination of docetaxel and abiraterone (Zytiga), investigators reported here.

“All but three of 21 evaluable patients had at least a 50% decrease in PSA levels with the combination, including 14 patients who had PSA responses ≥90%.

“Among 10 patients who could be assessed for response of measurable disease, six had partial responses, Scott Tagawa, MD, of Weill-Cornell Medical College in New York City, and colleagues reported at a poster highlights session at the American Society of Clinical Oncology meeting.”

Editor’s note: Prostate cancer patients who are treated with hormone therapy may become resistant to it and develop metastatic “castration-resistant prostate cancer” (CRPC). There is a lot of research being done to figure out good treatment strategies for these patients. The research described in this article shows promise for a treatment that combines the drugs docetaxel and abiraterone (brand name Zytiga). To learn more about new prospects for CRPC treatment, see our blog feature on the topic.

ASCO: Combo Hormone Tx Promising in Prostate Cancer

“A combination attack on androgens in metastatic prostate cancer resistant to initial hormone therapy drove down testosterone levels and appeared safe, according to a proof of concept study.

“Enzalutamide (Xtandi) plus abiraterone (Zytiga) dropped blood and bone marrow androgens down to undetectable levels for 80% of such patients, reported Eleni Efstathiou, MD, PhD, of the MD Anderson Cancer Center in Houston.

Editor’s note: This article discusses a treatment that may benefit men with metastatic prostate cancer that has become resistant to hormonal therapy (a condition known as castration-resistant prostate cancer or CRPC). The treatment, which combines the drugs enzalutamide (Xtandi) and abiraterone (Zytiga), was tested in a study with volunteer patients. The treatment appeared safe and also lowered testosterone levels—a promising sign that indicates potential cancer-fighting power. More studies will have to be done to determine just how well the treatment might work.