[Three-year follow-up of 12 patients with prostate cancer treated with monthly degarelix in a phase II clinical trial]

What Was Tested

The paper reports a study of Degarelix, published as a phase 2 clinical trial.

In this trial, a total of 13 patients were accrued at the Yamagata Prefectural Central Hospital from 2007 to 2008.

The median age was 80 years(range, 65-85 years), and clinical stages were T1c, T2, T3, and T4 in 1, 4, 6, and 2 patients, respectively.

Who Took Part

According to the abstract, 13 patients were involved.

The age groups tagged for this paper are older adults and people over 80, men only.

After completion of the phase II trial, 5 patients were treated with combined and rogen blockade(CAB)(leuprolide plus anti-androgen therapy), 2 patients were treated with single-agent leuprolide, 2 patients received single-agent bicalutamide, and 1 patient was followed-up without additional treatment.

How the Study Was Run

In design terms this was an open-label and multicenter study.

Nothing was hidden in this open-label Degarelix study: the patients and staff both knew the treatment.

Running at several centres spread the Degarelix study over different clinics and patient groups.

What Was Measured

The median prostate- specific antigen(PSA)level was 29.1 ng/mL(range, 6.3-427 ng/mL).

The PSA level declined in all patients.

Topics PubMed links to this paper include Gonadotropin-Releasing Hormone, Neoplasm Staging, Oligopeptides, Prostate-Specific Antigen and Prostatic Neoplasms.

What This Means in Plain Language

The paper is an open-label and multicenter study of Degarelix in 13 patients.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The publication is from 2014 (Gan to kagaku ryoho. Cancer & chemotherapy), a journal based in Japan.

More context: the Degarelix compound page, all human trials.