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Trial History Detail on 2012-04-03

CUHK_CCT00158

2008-03-06

Prospective

nil

No

No

No

Chi-Fai NG

Department of Surgery, 4/F, Clinical Science Building, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, NT

852-26322625;

email ngcf@surgery.cuhk.edu.hk

Professor, Department of Surgery

Chi-Fai NG

Department of Surgery, 4/F, Clinical Science Building, The Chinese University of Hong Kong, Prince of Wales Hospital,

852-26322625;

email ngcf@surgery.cuhk.edu.hk

Professor, Department of Surgery

Prospective trial of a herbal formula BYSH and saw palmetto in patients with hormonal refractory prostate cancer

Prospective trial of a herbal formula BYSH and saw palmetto in patients with hormonal refractory prostate cancer

Prospective trial of a herbal formula BYSH and saw palmetto in patients with hormonal refractory pro

Hong Kong

Yes

2007-08-23

Prostate Cancer

Drug

Traditional Chinese Medicine

up to 1 year

No

Inclusion criteria ■ Male patients aged more than 50 years old ■ Histologically confirmed prostate cancer ■ Clinically diagnosed as hormonal refractory carcinoma of prostate (HRPC) 1. Serum castration levels of testosterone. (less than 50 ng/ml) 2. Two consecutive rises of PSA 2 weeks apart defined as 2 successive increases with the first increase a minimum of 1 week from the baseline and the second increase a minimum of 1 week from the first increase. 3. A patient whose only evidence of progressive disease is an increasing PSA should have a value of at least 5 ng/mL before entering onto a clinical trial. 4. Documented PSA progression despite secondary hormonal manipulations*. • Either antiandrogen withdrawal or one secondary hormonal manipulation should have been done in order to fulfil the criteria for HRPC. 5. Antiandrogen withdrawal for at least 4 weeks for flutamide and 6 weeks for bicalutamide*. ■ With an Eastern Cooperative Oncology Group (ECOG) performance status 0-2. ■ Must have received their last radiation treatment at least 4 weeks earlier and their last dose of a therapeutic radionucleotide at least 8 weeks earlier. ■ Must at least 3 weeks since major operation.

Exclusion criteria ■ Patients with history of thromboembolic disease within previous 6 months ■ severe uncontrolled cardiovascular disease ■ Clinical significant neuropathy or other comorbid conditions ■ Patients who have: - Serum creatinine levels > 200 µmol/L (2.4 mg/dl) - Creatinine clearance < 50ml/min - WBC < 4.0 x 109/L, Hb < 10g/dl, PLT <100 x 109/L - Serum transaminases enzyme level > 1.5 upper normal level

>=50

nil

Male

Interventional

Non-randomized

Uncontrolled

Open label

Single group

2008-03-13

10

Complete

The primary end point of this study is the anti-tumour response Defined as ≥50% reduction in serum PSA level maintained on two consecutive evaluations at least 4 weeks apart.

The start of the time to PSA progression is the day treatment is initiated. If at least a 50% decline in PSA has been achieved, the end date is the time the PSA has increased 50% above the nadir at a minimum of 5 ng/mL (this is the same as the parameter for PSA response). For patients without a PSA decrease of this magnitude (or no decrease in PSA), the end point for progression will be calculated at the time a 25% increase in PSA has been achieved. All end dates require a confirmatory PSA at least 4 weeks apart. Toxicity (National Cancer Institute Common Toxicity Criteria version 2.0)

No

2015-07-06

ChiCTR-TRC-09000715

2010-05-04


Yes

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