Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000372583
Ethics application status
Approved
Date submitted
28/07/2004
Date registered
28/07/2004
Date last updated
28/07/2004
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study evaluating the role of docetaxel (Taxotere) in combination with thalidomide in men with hormone refractory prostate cancer
Scientific title
A feasibility and efficacy study, evaluating the prostate specific antigen (PSA) response, of taxotere/prednisone in combination with thalidomide in hormone refractory prostate cancer
Secondary ID [1] 55 0
National Clinical Trials Registry: NCTR588
Secondary ID [2] 56 0
Therapeutic Goods Administration (TGA): TGA 2004/172
Universal Trial Number (UTN)
Trial acronym
ProTat
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 51 0
Condition category
Condition code
Cancer 57 57 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will receive treatment with docetaxel 75 mg/msquared intravenously every 3 weeks (1 cycle). On day 1 patients will commence a daily dose of prednisone 10 mg orally and a 200 mg oral dose of thalidomide given daily. Prophylactic enoxaparin at a dose of 40 mg subcutaneous will be administered daily. Patients will continue to receive treatment until disease progression, patient intolerance or withdraw of consent. Maximum number of cycles is 10. After study treatment discontinuation, patients will be treated by their physicians as determined by usual practice and followed for survival.
Intervention code [1] 1102 0
Treatment: Drugs
Comparator / control treatment
Control group
Historical

Outcomes
Primary outcome [1] 89 0
1. PSA prostate specific antigen.
Timepoint [1] 89 0
Measured at baseline and 3 weekly intervals
Primary outcome [2] 90 0
2. Tumour lesion assessment.
Timepoint [2] 90 0
Measured after every second cycle for those patients with measurable disease
Primary outcome [3] 91 0
3. Progression free survival.
Timepoint [3] 91 0
Measured form registration to documented evidence of progression
Primary outcome [4] 92 0
4. Overall survival.
Timepoint [4] 92 0
Measured from registration to date of death
Secondary outcome [1] 181 0
1. Toxicity
Timepoint [1] 181 0
Measured at commencement of each cycle.
Secondary outcome [2] 182 0
2. Quality of life
Timepoint [2] 182 0
Measured at each cycle.

Eligibility
Key inclusion criteria
1. Histologically/cytologically proven prostate adenocarcinoma2. ALl patients are males, aged 18 years or more and must have prostate adenocarcinoma that is responsive or refractory to hormone therpay.3. Prior treatment with crticosteroids is allowed.4. life expectancy greater or equal to 3 months.5. prior surgery is allowed. At least 4 weeks must have elapsed since the completion of surgery.6. ECOG 0-27. Informed consent signed
Minimum age
18 Years
Maximum age
Not stated
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior cytotoxic chemotherapy (except monotherapy with estramustine)2. prior isotope therapy3. prior radiotherapy to >25% of bone marrow (whole pelvic radiation is not allowed)4. known brain leptomeningeal involvement.5. Other malignancy6. Uncontrolled medical condition7. Prior Deep venous thrombosis or pulmonary embolism

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/02/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 83 0
Commercial sector/Industry
Name [1] 83 0
Educational grant from Sanofi Aventis
Country [1] 83 0
Australia
Funding source category [2] 84 0
Commercial sector/Industry
Name [2] 84 0
Educational grant from Pharmion
Country [2] 84 0
Funding source category [3] 85 0
Charities/Societies/Foundations
Name [3] 85 0
Cancer Trials NSW
Country [3] 85 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Country
Australia
Secondary sponsor category [1] 67 0
None
Name [1] 67 0
Nil
Address [1] 67 0
Country [1] 67 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 589 0
Royal North Shore Hospital
Ethics committee address [1] 589 0
Ethics committee country [1] 589 0
Australia
Date submitted for ethics approval [1] 589 0
Approval date [1] 589 0
15/03/2004
Ethics approval number [1] 589 0
0402-042M
Ethics committee name [2] 590 0
Sydney Haematology Oncology Clinics
Ethics committee address [2] 590 0
Ethics committee country [2] 590 0
Australia
Date submitted for ethics approval [2] 590 0
Approval date [2] 590 0
Ethics approval number [2] 590 0
Ethics committee name [3] 591 0
Border Medical Oncology
Ethics committee address [3] 591 0
Ethics committee country [3] 591 0
Australia
Date submitted for ethics approval [3] 591 0
Approval date [3] 591 0
Ethics approval number [3] 591 0
Ethics committee name [4] 592 0
Lismore Base Hospital
Ethics committee address [4] 592 0
Ethics committee country [4] 592 0
Australia
Date submitted for ethics approval [4] 592 0
Approval date [4] 592 0
Ethics approval number [4] 592 0
Ethics committee name [5] 593 0
Port Macquarie Base Hospital
Ethics committee address [5] 593 0
Ethics committee country [5] 593 0
Australia
Date submitted for ethics approval [5] 593 0
Approval date [5] 593 0
Ethics approval number [5] 593 0

Summary
Brief summary
The ProTaT trial is a phase II trial evaluating the safety and activity of the combination of docetaxel (Taxotere), prednisone and Thalidomide in men with metastatic hormone refractory prostae cancer. The hypothesis is that the combination of a standard systemic therapy, docetaxel, with and antiangiogenic agent may improve the response rate in patients with this disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36297 0
Address 36297 0
Country 36297 0
Phone 36297 0
Fax 36297 0
Email 36297 0
Contact person for public queries
Name 10291 0
Sally McCowatt
Address 10291 0
Oncology Clinical Trials Unit
Royal North Shore Hospital
St Leonards
Sydney NSW
Country 10291 0
Australia
Phone 10291 0
+61 2 99265049
Fax 10291 0
+61 2 94821341
Email 10291 0
smccowatt@nsccahs.gov.au
Contact person for scientific queries
Name 1219 0
Dr Gavin Marx
Address 1219 0
11/49 Plamerston rd
Hornsby
NSW 2077
Country 1219 0
Australia
Phone 1219 0
+ 61 2 94765844
Fax 1219 0
+ 61 2 94821341
Email 1219 0
gmarx@shoc.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.