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Year : 2003  |  Volume : 19  |  Issue : 2  |  Page : 135-139

Early report of randomized double blind clinical trial of hormonal therapy of carcinoma of prostate (CAP) stage D2

Department of Uro-Oncology, Tata Memorial Hospital, Mumbai, India

Correspondence Address:
Jagdeesh N Kulkarni
Department of Uro-Oncology, Tata Memorial Hospital, Parel, Mumbai - 400 012
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Source of Support: None, Conflict of Interest: None

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Objectives: We herein report our experience of double blind randomized clinical trial comparing combined an­drogen blockade vs monotherapy in stage D2 CaP. Patients and Methods: Through June 1999 and May 2001, 100 patients of stage D2 CaP were randomized into placebo (44) and flutamide (42) group after orchiectomy in double blind fashion using the strictest criteria. All men and histological proof of CaP with bone metastasis dem­onstrated on imaging: bone scan and skeletal survey. These patients were further substratified according to number o f bony metastases into high volume disease (HVD>5 sites) and low volume disease (LVD<5 sites). The follow-up was at 3 month intervals. Criteria for decoding were clinical or serological progression and serious adverse effects. Results: Of the 100 patients recruited in the trial, 48 had HVD and 52 LVD. Treatmentwise they were almost equally distributed in flutamide group and placebo group. In the follow-up ranging front 6 to 24 months, 30 out of 100 patients (30%) required decoding, reasons for decod­ing were progression of disease in 25 and serious adverse effects in remaining 5. These 25 patients were further analyzed according to treatment group, volume of metas­tasis pre -orchiectomy PSA and Gleason score. We observed that number of bony metastases had impact over the dura­tion of response to hormonal therapy. Discussion: We initiated this simple trial to address the issue of benefit of total androgen blockade over monotherapy in Indian population. In the initial analysis, we observed that treatment group did not make any impact over the response. While subset of prostate cancer with large number of bony metastases has higher propensity to convert into hormone refractory cancer Conclusions: Addition of flutamide did not provide ben­efit. We observed that large number of bony metastases had poor response to hormonal therapy, hence it requires large trial to substantiate this initial observation.

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