A pilot randomised controlled trial by Sooriakumaran and colleagues at Guildford have published results in Anticancer Research showing a 4 week regimen of celecoxib to result in measurable biological effects in prostate cancer tissue (1). The study involved 45 patients with cT1-2 prostate cancer prior to radical prostatectomy. The men were randomised celecoxib 400mg twice daily or no treatment. The authors conclude that the "findings warrant further investigation."
The STAMPEDE Trial Management Groups welcomes the publication showing encouraging biology effects of a COX-2 inhibitor on prostate cancer tissue as this further supports the inclusion of the celecoxib arms in the MRC STAMPEDE trial (ISRCTN78818544) (2;3). STAMPEDE trial recruits men with high-risk prostate cancer, including those with newly-diagnosed locally advanced or metastatic disease and those who have failed previous local therapy; these are later stages of disease than described by Sooriakumaran et al.
Celecoxib is one of three research agents in this 6-arm trial which is using new, adaptive methods to assess these agents efficiently and concurrently (4). Men starting long-term hormone therapy for the first time are randomised to supplement this treatment with the COX-2 inhibitor, celecoxib (C), given for one year at a dose of 400mg/day; or the third-generation bisphosphonate, zoledronic acid (ZA), for 2 years; or the taxane chemotherapy, docetaxel (D), for 6 cycles. Patients are randomised to (i) HT alone (control), (ii) HT + D, (iii) HT + ZA, (iv) HT + C, (v) HT + D + ZA or (vi) HT + ZA + C. The 2:1:1:1:1:1 randomisation means that two sevenths of patients are randomised to receive celecoxib. Between 2,000 and 3,000 will join the trial to assess these agents against a primary outcome measure of overall survival. The trial is already open in over 50 centres throughout the United Kingdom, including Guildford, with more than 1000 patients recruited. Accrual will soon commence in Switzerland.
STAMPEDE is sponsored by the Medical Research Council (MRC), run from the MRC Clinical Trials Unit with the National Cancer Research Institute Prostate Clinical Studies Group and grant funded by Cancer Research UK with additional support from Novartis, Sanofi-Aventis and Pfizer.
Additional trial groups or centres are invited to joining the trial. For more information, contact email@example.com.
- Sooriakumaran P, Coley HM, Fox SB, Macanas-Pirard P, Lovell DP, Henderson A et al. A randomized controlled trial investigating the effects of celecoxib in patients with localized prostate cancer. Anticancer Res 2009; 29(5):1483-1488.
- James ND, Sydes MR, Clarke NW, Mason MD, Dearnaley DP, Anderson J et al. Systemic therapy for advancing or metastatic prostate cancer (STAMPEDE): a multi-arm, multistage randomized controlled trial. BJU Int 2009; 103(4):464-469.
- James ND, Sydes MR, Clarke NW, Mason MD, Dearnaley DP, Anderson J et al. STAMPEDE: Systemic Therapy for Advancing or Metastatic Prostate Cancer--a multi-arm multi-stage randomised controlled trial. Clin Oncol (R Coll Radiol ) 2008; 20(8):577-581.
- Parmar MK, Barthel FM, Sydes M, Langley R, Kaplan R, Eisenhauer E et al. Speeding up the evaluation of new agents in cancer. J Natl Cancer Inst 2008; 100(17):1204-1214.