| Methods |
Design: randomised clinical trial. Multicentre. Period of study: not reported. Sample size: no justification. Generation of allocation: not described. Allocation concealment: not described. Blinded assessment of outcomes: not described. Withdrawals: described (for a median follow‐up of 48 months 306 patients out of 626 randomised have gone off study, 162 in intermittent and 144 in the continuous. 57 patients in intermittent and 39 continuous have gone off study for subjective progression. 72 patients in intermittent and 50 in continuous have gone off study for subjective or objective progression. 72 patients in the intermittent arm and 69 in the continuous arm have died). Intention‐to‐treat analysis: not reported. Follow‐up: median of 48 months. |
| Participants |
Of 765 patients registered 626 have been randomised (314 in the intermittent arm and 312 in the continuod arm). At randomisation 23.7% of patient's randomised have PSA in excess of 4 ng and the others 76.3% have PSA<4. Inclusion criteria: histological proven PCa T3‐T4M0 and M1 patients, WHO 0‐2, age<85, previously untreated. |
| Interventions |
All patients were registered and treated with CPA 200 mg for 2 weeks and then a monthly depot injection of LHRA analogue (decapeptyl) plus 200 mg of CPA daily. After 3 months of therapy if PSA was below 4 or 80% below the initial value, patients were randomised between intermittent MAB and continuous MAB treatment. |
| Outcomes |
The outcomes measures were side effects, quality of life, sexually active, progression and survival. |
| Notes |
ONLY ABSTRACT AVAILABLE (PRELIMINARY RESULTS).
Contact with the author in 02th October 2005. (Question asked: Is it possible to make available the raw data from all participants?) Waiting response.
Score of the trial using the scale devised by Jadad 1996 was classified as 2 (two) ‐ the study described as randomised and also described the withdrawals. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |
