Clinical Trials

ASCO 2014: Combining Advanced Hormone Therapies (Zytiga & Xtandi) Shows Promise for Men with Advanced Prostate Cancer

In my continuing reports about interesting and pertinent information released at the ASCO 2014 meeting one abstract described a phase 2 trial combining an attack on androgens in metastatic prostate cancer resistant to initial hormone therapy. This proof of concept study showed that combining Enzalutamide (Xtandi) plus abiraterone (Zytiga) drove down testosterone levels and appeared [...]

By Malecare|2017-10-19T10:48:10-04:00June 5th, 2014|2nd line hormone therapy, abiraterone acetate, ADT, Advanced Prostate Cancer, ASCO, Clinical Trials, Clinical Trials, Combination Therapy, Drugs & Treatments, enzalutamide, Uncategorized, Xtandi, Zytiga|1 Comment

The ASCO 2014 Game Changer – Early Chemotherapy for Some Men Extends Survival

I was asked if there was one item that was a real game changer at the American Society of Clinical Oncologists (ASCO) meeting for men with advanced prostate cancer. The answer is yes, at this meeting it was formally shown by a study that starting chemotherapy (docetaxel) along with androgen deprivation therapy (ADT) in some [...]

By Malecare|2014-06-03T10:23:15-04:00June 3rd, 2014|ADT, Advanced Prostate Cancer, Chemo Therapy, Clinical Trials, Clinical Trials, Combination Therapy, Drugs & Treatments, Uncategorized, Understanding APC|4 Comments

Preliminary Data Released for A Phase II Trial of Sipuleucel-T (Provenge) with Concurrent or Sequential Enzalutamide (Xtandi) in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

There will be an abstract presented at the Upcoming (May 31- June 3) American Society of Clinical Oncologist Annual Meeting (ASCO) providing very preliminary data on a clinical trial combing Sipuleucel-T (Provenge) and enzalutamide (Xtandi) in men with metastatic castrate resistant prostate cancer (mCRPC). This rational for conducting this trial is the lack of cross [...]

By Malecare|2020-02-04T10:12:06-05:00May 16th, 2014|Advanced Prostate Cancer, ASCO, Clinical Trials, Clinical Trials, Combination Therapy, Drugs & Treatments, enzalutamide, immunotherapy, Provenge, Uncategorized, vaccines, Xtandi|0 Comments

A Surprising Biochemical Response to Ketoconazole In Post-Chemotherapy mCRPC Men When Compared to the Zytiga Trial Results

It has always been assumed that Ketoconazole, when used for the treatment of men with metastatic castration resistant prostate cancer (mCRPC), would not be as potent as abiraterone (Zytiga), but there has never been any head to head comparison to demonstrate this assumption! Ketoconazole is a less potent inhibitor of the CYP-17 enzyme, the mode [...]

By Malecare|2014-05-12T17:10:17-04:00May 12th, 2014|2nd line hormone therapy, Advanced Prostate Cancer, Chemo Therapy Failure, Clinical Trials, Clinical Trials, Drugs & Treatments, ketoconazole, Uncategorized, Understanding APC, Zytiga|0 Comments

Just One Year On Androgen Deprivation (ADT) Creates Significant Lipid and Glucose Metabolism Problems

It is a widely understood that androgen deprivation therapy (ADT) causes adverse side effects and events. Some researchers believe that the ADT-induced alterations in lipid and glucose metabolism may be race-dependent. To evaluate this concern the researchers recruited Japanese men with newly diagnosed prostate cancer who also underwent at least one year of ADT. They [...]

By Malecare|2017-10-19T10:48:24-04:00May 6th, 2014|Advanced Prostate Cancer, Clinical Trials, Clinical Trials, Drugs & Treatments, Hormone Therapy, Uncategorized, Understanding APC|0 Comments

Developing a New Prognostic Model for in Men with First Line Chemotherapy

Current Prognostic models for overall survival (OS) for men with metastatic castration-resistant prostate cancer (mCRPC) have become dated. They don’t adequately reflect the many new drugs used in clinical practice. To develop a relevant model data from a phase III trial of 1,050 men with mCRPC were used (Cancer and Leukemia Group B CALGB-90401 [Alliance]) was evaluated. [...]

By Malecare|2014-04-29T20:14:20-04:00April 29th, 2014|Advanced Prostate Cancer, biomarkers, Clinical Trials, Clinical Trials, Research, Uncategorized|0 Comments

The Ipilimumab (Yervoy) Results – A Failure that Should Not Have Been A Failure

Last October at the European Cancer Congress 2013 there was a release of data from a phase 3 study of Ipilimumab (CA 184-043) that showed that it might be effective in treating castration-resistant prostate cancer in men who have a low burden of disease; however it failed to show at the required 95% confidence level [...]

By Malecare|2020-02-04T10:12:02-05:00April 22nd, 2014|Advanced Prostate Cancer, Clinical Trials, Clinical Trials, Drugs & Treatments, ipilimumab, Uncategorized, Yervoy|2 Comments

Tri-weekly Docetaxel Versus Bi-weekly Docetaxel as a Treatment for Advanced Castration Resistant Prostate Cancer: Quality of Life Analysis

Administering chemotherapy using docetaxel (taxotere or T) on a bi-weekly basis with prednisone improved progression free survival and overall survival when compared with the standard tri-weekly schedule for men with advanced castration resistant prostate cancer (CRPC) (Lancet Oncol. 2013;14:117-124). However, quality of life (QoL) differences have not been evaluated. In a trial to evaluate the [...]

By Malecare|2017-10-19T10:48:30-04:00March 20th, 2014|Advanced Prostate Cancer, Chemo Therapy, Clinical Trials, Clinical Trials, Drugs & Treatments, Uncategorized, Understanding APC|2 Comments

Application for the FDA Approval of Xtandi in the Pre-Chemo State Has Finally been Submitted

The good news is that finally Astellas and Medivation have submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of XTANDI (enzalutamide) for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy. As of today XTANDI is currently only approved for [...]

By Malecare|2014-03-18T11:07:29-04:00March 18th, 2014|Advanced Prostate Cancer, Clinical Trials, Clinical Trials, Drugs & Treatments, enzalutamide, FDA, Uncategorized, Xtandi|0 Comments

Can Zytiga Be Used In Men Previously Treated With Ketoconazole: A Prospective Phase II Study

Some men with advanced prostate cancer have been given the antifungal treatment Ketoconazole (Keto) as a second line hormone treatment. Like Keto, this newer hormone treatment that is now available, Abiraterone acetate (AA) (Zytiga) works by inhibiting CYP17, the rate-limiting enzyme in androgen biosynthesis. The question being asked, if Keto has failed ,given its similar [...]

By Malecare|2017-10-19T10:48:35-04:00February 14th, 2014|abiraterone acetate, Advanced Prostate Cancer, Clinical Trials, Clinical Trials, Drugs & Treatments, ketoconazole, Uncategorized, Zytiga|0 Comments