Prostate Cancer

Ferring Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved the trade name Firmagon (degarelix for injection) for its prostate cancer treatment previously marketed under the generic name degarelix.

In 2008, approximately 186,000 American men were diagnosed with prostate cancer, resulting in about 28,600 deaths.[1] It is the most commonly diagnosed cancer, and second only to lung cancer as the leading cause of cancer death in men.

The optimal treatment for clinically localized prostate cancer is an ongoing subject of controversy.[1] As pointed out by Drs. Mirhadi and Sandler, no randomized trial has compared radical prostatectomy (RP) to radiation therapy (RT), and no study has definitively “proven” the superiority of one technique over the other. Therefore, we disagree with the author’s conclusion that RT “is the ‘only way to go’ when managing early-stage prostate cancer.”

For the September and October issues of ­ONCOLOGY, we have assembled a team of experts in the diagnosis and management of early-stage prostate cancer-ie, disease that has not clinically metastasized at first presentation, and which is theoretically curable-and have asked them to take a position on optimal patterns of care.

Prostate cancer experts agree on one issue: No single treatment can be considered universal for men diagnosed with prostate cancer. There are myriad choices and considerations to be reviewed with every diagnosis. In addition, there are conflicting data about when, or if, men require screening for prostate cancer as well as when to start therapy for confirmed disease.

Prostate cancer patients who undergo androgen deprivation therapy have an increased chance of developing bone- and heart-related side effects compared to patients who do not undergo ADT, according to an analysis in Cancer online (April 29, 2009).

A new technique, ultrasonic tissue-type imaging, could revolutionize the detection and treatment of prostate cancer, according to Ernest J. Feleppa, PhD, research director of the Frederic L. Lizzi Center for Biomedical Engineering at the Riverside Research Institute in New York. “The method seems to be capable of distinguishing cancerous from noncancerous tissue in the prostate,” Dr. Feleppa said

Crawford and Hou[1] review the data on luteinizing hormone-releasing hormone (LHRH) antagonists in prostate cancer. They describe the results of a phase III trial comparing monthly degarelix to monthly leuprolide in men with advanced prostate cancer. Degarelix treatment was associated with a more rapid decline of serum testosterone, and was not associated with an initial surge of serum testosterone seen during the first few days of treatment with leuprolide. They discuss the role of this new form of medical gonadal suppression for the treatment of prostate cancer.

The recent US Food and Drug Administration (FDA) approval of degarelix, a luteinizing hormone-releasing hormone (LHRH) antagonist, has renewed interest in this class of drugs as a prostate cancer therapy. Approval was based on a prospective phase III trial of 610 patients randomized to one of two dosing schedules of degarelix, or standard-of-care monthly leuprolide acetate monotherapy, with initial antiandrogen therapy allowed at the treating physician’s discretion for prevention of clinical flare.[1]

Drs. Crawford and Hou provide an important clinical introduction to a novel class of hormonal agents that have been under development for several decades for the treatment of advanced and metastatic prostate cancer.

Physicians have known since 1941 that testosterone suppression benefits patients with symptomatic metastatic prostate cancer.[1] The pioneering study in this regard showed that estrogen therapy achieved comparable efficacy to castration by improving acid and alkaline phosphatase levels associated with relief of cancer-related symptoms. More than 6 decades later, however, many of the therapies subsequently developed for achieving androgen deprivation still suffer from serious limitations.

Ferring Pharmaceuticals announced the launch of a phase IIIB clinical trial of degarelix for injection, a new injectable gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the US Food and Drug Administration (FDA) for the treatment of hormone-sensitive advanced prostate cancer.

Is the era of PSA screening coming to an end? Proponents say the test saves lives, but a growing number of critics contend that widespread screening does more harm than good. The ongoing controversy over the clinical value of PSA screening has long been perpetuated by a lack of persuasive data, leaving doctors and their patients with difficult conversations and a host of perplexing decisions.

PSA is the most important biomarker in a common malignancy. I will continue to test men starting at age 35 if there is a family history of prostate or breast cancer. Depending on the vitality of the individual, I will continue with PSA testing for the duration of the man’s health.

Like the vast majority of men, I was “stupid” where my healthcare was concerned. I never asked for a copy of my blood work or questioned the results of my tests. After all, we treat our doctors like gods.

Although significant questions remain, the recently released IMPACT study is a major victory for Dendreon's prostate cancer vaccine, Provenge. Two years ago, Provenge was denied FDA approval causing a wave of public outcry. Now, all eyes are on FDA as Dendreon gears up to once again tackle the approval process.

Aureon Laboratories has released Prostate Px, a test to predict prostate cancer regression and disease recurrence at the time of diagnosis. The technology combines molecular biomarkers, histological and clinical information with advanced mathematics, said Ricardo Mesa-Tejada, MD, vice president of pathology and medical director of Aureon Laboratories.

Ascenta Therapeutics announced positive preliminary results from its Phase II study of AT-101 in combination with docetaxel (Taxotere) and prednisone in men with docetaxel refractory, castrate resistant prostate cancer (CRPC). AT-101 is an oral, pan-Bcl-2 inhibitor.

VIENNA-Image-guided intensity-modulated radiotherapy, high-intensity focused ultrasound, and cryotherapy are increasing the curative treatment options for men with prostate cancer. The problem is how to determine which patients are most suitable for these therapies.

The value of a molecular marker in cancer depends on whether its use will improve clinical outcomes. Studies on tumor biomarkers are in preliminary stages, and there is a “near total” absence of any papers examining the clinical implications of using markers, according to a speaker at the 2009 Genitourinary Cancers Symposium.

Prostate-specific antigen testing, the most widely used screening tool in prostate cancer, has long had both critics and supporters. Two studies published in the New England Journal of Medicine continue to generate debate over the value of PSA screening. The papers have two major points in common: They are large-scale studies, and they leave more questions than answers.

DENVER—Designer T cells that attack tumors with a vengeance could be the future of prostate cancer treatment. Although the results are very preliminary, the incorporation of designer T cells into prostate cancer treatment led to a significant reduction in PSA levels, according to researchers from Boston University School of Medicine in Providence, R.I.

SAN FRANCISCO-Studies show improved outcomes when androgen deprivation therapy (ADT) is part of the care for men with intermediate-risk prostate cancer, said Mack Roach III, MD, taking the “pro” side of a debate on the issue. But “con” speaker Arul Mahadevan, MD, argued that the studies in question included mostly high-risk patients, and that monotherapy is effective in intermediate-risk patients.

Osteoporosis, the most common late effect of cancer treatment in the US, occurs with greater frequency among cancer survivors than the general population. Survivors of breast cancer, prostate cancer, and childhood leukemia are at particularly high risk for changes in bone mineral density (BMD) / osteoporosis that can lead to fractures.[1] In breast and prostate cancer patients, bone effects are often the result of endocrine therapy–induced alterations in bone microarchitecture. They also can be caused by other types of cancer therapy, vitamin D deficiency, and other physiological changes that may or may not be related to cancer or its treatment. In childhood leukemia patients, bone effects can be caused by a variety of factors, including corticosteroid therapy, radiation therapy to the brain, and the disease itself.

Ferring Pharmaceuticals received approval from the US Food and Drug Administration (FDA) for degarelix, a new injectable gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for patients with advanced prostate cancer.