Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00158

2 Trial Registration Date

2008-03-06

i Registration Status

Prospective

3 Secondary IDs

nil

4 Source(s) of Funding

No

5 Primary Sponsor

No

6 Secondary Sponsor

No

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Chi-Fai NG

ii Address

iii Phone

852-26322625; ngcf@surgery.cuhk.edu.hk

iv Email

email

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Chi-Fai NG

ii Address

iii Phone

852-26322625; ngcf@surgery.cuhk.edu.hk

iv Email

email

v Affiliation

vi Country

9 Official Scientific Title of the Study

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

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

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

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2007-08-23

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Prostate Cancer

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Traditional Chinese Medicine

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

up to 1 year

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

No

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion criteria Ü Male patients aged more than 50 years old Ü Histologically confirmed prostate cancer Ü 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*. Ü With an Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Ü 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. Ü Must at least 3 weeks since major operation. Exclusion criteria Ü Patients with history of thromboembolic disease within previous 6 months Ü severe uncontrolled cardiovascular disease Ü Clinical significant neuropathy or other comorbid conditions Ü Patients who have: ¡µ Serum creatinine levels > 200 £gmol/L (2.4 mg/dl) ¡µ Creatinine clearance < 50ml/min ¡µ WBC < 4.0¡Ñ109/L, Hb < 10g/dl, PLT <100¡Ñ109/L ¡µ Serum transaminases enzyme level > 1.5 upper normal level

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2008-03-13

21 Target Sample Size

10

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

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.

24 Secondary Outcome

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)

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-07-06

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

nil

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Trial History Detail on 2008-03-07