Cougar prostate cancer trial

Many survivors who are not as progressed have been frustrated because this trial was restricted solely to late stage survivors. Many of us feel that abiraterone might be able to provide a positive profile for earlier progressed disease than the current trial allows. If this new trial provides a positive result it would offer the potential for FDA approval of abiraterone acetate for use significantly earlier in the course of the disease.

The trial will be a randomized, double-blind, placebo-controlled trial CB plus prednisone in survivors with metastatic, castration-resistant prostate cancer who have not yet received treatment with chemotherapy.

The trial will be randomized so that subjects will receive abiraterone acetate plus prednisone or placebo plus prednisone. Sooner or later, however, the tumour becomes resistant to ADT and can grow without hormones, at which stage the disease becomes classified as HRPC.

However, before this stage is reached tumours often adapt, gaining the ability to grow using the very low levels of androgen produced by the adrenal gland. At this point, second-line agents can be used to block the adrenal androgens, before the patient requires chemotherapy. But because there is no FDA approved second-line hormonal treatment, the substantial proportion of HRPC that remains hormone driven is very hard to treat. In the US, the anti-fungal ketoconazole is mostly commonly used, off-label, to knock out the adrenal gland, but at high and often toxic doses with limited efficacy, which is why the drug is not approved for this use in many countries, including the UK.

The company hopes it will yield a new treatment option for patients who fail ADT, but whose tumours remain dependent on testosterone. There is a substantial market for hormone-based therapies. A large proportion of patients receiving these drugs would benefit from an effective second-line hormone treatment, if one was available. It has also demonstrated tumour shrinkage, and efficacy in terms of PSA decline a marker of prostate cancer is better than other HRPC drugs on the market.

On top of that, the safety profile has been favourable and high doses have been used without toxicity. The company now needs to demonstrate a definite effect on survival, and plans to starts a phase III trial in the first half of News on the final design of the trial, which is likely to be in a post-chemotherapy setting, and go-ahead from regulators, are key events on the horizon. Drug Information available for: Prednisone Abiraterone acetate Abiraterone.

FDA Resources. Arms and Interventions. Outcome Measures. Primary Outcome Measures : Overall Survival [ Time Frame: Up to 60 months ] Overall survival is defined as the time interval from the date of randomization to the date of death from any cause.

Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information. Publications automatically indexed to this study by ClinicalTrials.

J Clin Oncol. Epub Dec A prognostic index model for predicting overall survival in patients with metastatic castration-resistant prostate cancer treated with abiraterone acetate after docetaxel. Ann Oncol. Does Gleason score at initial diagnosis predict efficacy of abiraterone acetate therapy in patients with metastatic castration-resistant prostate cancer?

An analysis of abiraterone acetate phase III trials. Epub Nov High subcutaneous adipose tissue predicts the prognosis in metastatic castration-resistant prostate cancer patients in post chemotherapy setting. Eur J Cancer. At the final The median radiographic professional-free survival rPFS with abiraterone acetate was After protocol, the rate of subsequent therapy with either cabazitaxel, docetaxel, and enzalutamide was similar in both groups.

Forty-four percent of patients randomized to placebo crossed over to abiraterone acetate. Baseline characteristics were similar between the two randomized groups, including median time from initial diagnosis to first dose 5.

COU-AA enrolled patients who had very little to no pain that was associated with their disease, and, in fact, patients were required to not be taking opiates at the time of enrollment. Patients receiving abiraterone went 1 year longer than patients in the placebo arm without requiring opiate analgesics.

Interestingly, it took a long time for the majority of patients on the study to require opiates, and so this was one of the later endpoints that matured.