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Trial registered on ANZCTR


Registration number
ACTRN12607000082404
Ethics application status
Not yet submitted
Date submitted
17/01/2007
Date registered
24/01/2007
Date last updated
24/01/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to evaluate the feasibility, safety and tolerability of neoadjuvant triple therapy with zoledronic acid, docetaxel, and luteinising hormone-releasing hormone (LH-RH) analogue for men with high-risk prostate cancer to be treated by radical prostatectomy
Scientific title
A pilot study to evaluate the feasibility, safety and tolerability of neoadjuvant triple therapy with zoledronic acid, docetaxel, and luteinising hormone-releasing hormone (LH-RH) analogue for men with high-risk prostate cancer to be treated by radical prostatectomy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 1574 0
Condition category
Condition code
Cancer 1676 1676 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Docetaxel 75mgm/m2 intravenously every 3 weeks for 4 cycles.
Zoledronic acid 4mgm intravenously every 3 weeks for 4 cycles.
Goserelin acetate 10.5 mgm subcutaneously x 1 dose.
All administered prior to radical prostatectomy.
Intervention code [1] 1562 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2321 0
Safety: haematology and biochemistry evaluation.
Timepoint [1] 2321 0
Weekly whilst receiving therapy, then 3/12 and 24/12 following radical prostatectomy.
Primary outcome [2] 2322 0
Tolerability: assessment of adverse events.
Timepoint [2] 2322 0
Weekly during therapy, then 3/12 and 24/12 following radical prostatectomy.
Secondary outcome [1] 4049 0
pathological response
Timepoint [1] 4049 0
histopathology from radical prostatectomy
Secondary outcome [2] 4050 0
Prostatic Specific Antigen (PSA) measurement
Timepoint [2] 4050 0
post radical prostatectomy, measured at 3/12 and 24/12 post surgery.

Eligibility
Key inclusion criteria
Inclusion criteria:Provision of written informed consent, Prostate cancer confirmed by biopsy within 6 weeks prior to consent. At least one of the following: PSA level > 15 g/L, Gleason score > 8, Clinical stage T2b or T3 disease at study entry. >50% of positive coresConsidered suitable for radical prostatectomy
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:Evidence of metastatic diseasePrior cytotoxic chemotherapy.Prior hormone therapy.Treatment with an investigational agent in the last 4 weeks.Other co-existing malignancies or malignancies diagnosed within the last 2 years with the exception of non-melanoma skin cancer.Incomplete healing from previous surgery.Absolute neutrophil count (ANC) < 1 x 109/L or platelets < 100 x 109/L.Serum bilirubin > 1.25 times the upper limit of reference range (ULRR).Initial serum creatinine 1.5 times the ULN and/or calculated creatinine clearance (by Cockroft-Gault Formula) <60 ml/min and/or known progressive renal disease. ALT or AST > 2.5 times the ULRR.Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.Recent (within 6 weeks) or planned dental or jaw surgery (e.g.extraction, implants)In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial.

Study design
Purpose of the study
Treatment
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1822 0
Hospital
Name [1] 1822 0
The Royal Melbourne Hospital
Country [1] 1822 0
Australia
Primary sponsor type
Hospital
Name
Urology Department The Royal Melbourne Hospital
Address
Country
Australia
Secondary sponsor category [1] 1642 0
Hospital
Name [1] 1642 0
Oncology Department The Royal Melbourne Hospital
Address [1] 1642 0
Country [1] 1642 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3409 0
Ethics approval has been sought from the Melbourne Health
Ethics committee address [1] 3409 0
Ethics committee country [1] 3409 0
Australia
Date submitted for ethics approval [1] 3409 0
Approval date [1] 3409 0
Ethics approval number [1] 3409 0

Summary
Brief summary
Certain patients are at high risk of developing secondary, or metastatic, prostate cancer, after radical prostatectomy. These are patients whose prostate biopsy shows that they have a high Gleason grade, or aggressive prostate cancer, patients whose PSA level is high (>10ng/mL) or whose prostate feels abnormal on digital rectal examination.
The standard treatment approach for men with this high risk of secondary prostate cancer is close observation by their treating doctor and appropriate treatment if prostate cancer returns. This study aims to compare this standard approach with giving patients the combination of a drug called zoledronic acid (also known as Zometa®) a drug called docetaxel (also known as Taxotere®) and luteinising hormone-releasing hormone (LH-RH) analogue also known as hormone therapy.

Zoledronic acid, docetaxel and hormone therapy are routinely used in men with prostate cancer that has spread to the bone or other parts of the body (metastatic disease). Zoledronic acid is used in this situation to prevent bone complications from the cancer including fractures. Docetaxel is a chemotherapy drug that is used in this situation to control symptoms and prolong survival. Both drugs are routinely used in a variety of other cancers for the same reasons. Hormone therapy used to reduce testosterone production. Testosterone stimulates the growth of prostate cancer.

An additional, non-compulsory part of the study will be to look at the usefulness of examining patient’s prostate tumors to determine reasons why some tumors respond to therapy and others do not.. You will be given a second Plain Language Statement regarding this additional study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27496 0
Address 27496 0
Country 27496 0
Phone 27496 0
Fax 27496 0
Email 27496 0
Contact person for public queries
Name 10751 0
Helen Crowe
Address 10751 0
Urology Department
3 Centre
The Royal Melbourne Hospital
Grattan St
Parkville VIC 3050
Country 10751 0
Australia
Phone 10751 0
+61 3 93428442
Fax 10751 0
Email 10751 0
[email protected]
Contact person for scientific queries
Name 1679 0
Professor Anthony J Costello
Address 1679 0
Urology Department
3 Centre
The Royal Melbourne Hospital
Grattan St
Parkville VIC 3050
Country 1679 0
Australia
Phone 1679 0
+61 3 93427294
Fax 1679 0
Email 1679 0
[email protected]

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.