A Randomised Phase II Trial Comparing Docetaxel Plus Prednisone with Docetaxel Plus Prednisone Plus Low-Dose Cyclophosphamide in Castration-Resistant Prostate Cancer

Abstract

Background: Docetaxel plus prednisone is a standard treatment for castration-resistant prostate cancer. Cyclophosphamide may be an effective combination partner. Methods: This randomised, multicentre, phase II trial compared the combination therapy of docetaxel plus prednisone plus cyclophosphamide with the standard therapy of docetaxel plus prednisone. Results: Thirty-three patients received six 3-week treatment cycles (in total 171 cycles). During treatment, an adequate decline in prostate-specific antigen was seen in both groups (p = 0.068) without between-group differences (p = 0.683). No relevant differences between within-group changes were observed for blood pressure, weight, pain score, laboratory variables or quality of life. There were no serious side effects apart from leucopenia requiring treatment (docetaxel + prednisone + cyclophosphamide arm) and no drug-related withdrawals; all three fatalities were considered to be cancer related. Conclusions: The oncological effectiveness and tolerability of docetaxel plus prednisone were supported; an additional effect of cyclophosphamide was not detected. However, the small number of patients and short observation period restrict the generalisability of the results.

Translating Clinical Evidence-Based Medicine into the Real World: Single-Center Experience with Cabazitaxel in Metastatic Prostate Cancer Patients

“…AA or enzatulamide may be preferable to chemotherapy both in patients with asymptomatic disease and in patients with comorbidities or factors predisposing to poor tolerance of chemotherapy. On the other hand, for patients with rapidly progressing disease or visceral metastases, or patients with a poor response to initial androgen deprivation therapy, the use of chemotherapy may be preferred [17,18]. Age should not be a limiting factor as efficacy has been reported irrespective of the overall health status and tumor response even for very elderly patients [19].…”

Chemotherapy in Prostate Cancer

“…A small randomized phase II trial comparing docetaxel/prednisone to docetaxel/prednisone/cyclophosphamide showed no difference in response rate [58]. Regan et al [59] analyzed seven phase I and II studies that combined carboplatin with either docetaxel or paclitaxel.…”

Gene interference strategies as a new tool for the treatment of prostate cancer

“…The great limit of this therapy is chemotherapy resistance. In a recent study on 125 patients with an adenocarcinoma in progression though castrate levels of testosterone, the authors explored an intermittent chemotherapy with docetaxel and prednisone to evaluate immunotherapy maintenance treatment and the results were encouraging [38,39].…”