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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00258765




Registration number
NCT00258765
Ethics application status
Date submitted
24/11/2005
Date registered
28/11/2005
Date last updated
26/04/2010

Titles & IDs
Public title
Adjuvant Docetaxel-Zoledronic Acid in High-risk Early Prostate Cancer Following Prostatectomy.
Scientific title
A Phase IIb Randomised Clinical Trial of the Tolerability, Safety and Efficacy of Adjuvant Docetaxel-Zoledronic Acid After Prostatectomy for High-risk Early Prostate Cancer (AD-ZAP).
Secondary ID [1] 0 0
CZOL446GAU15
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zoledronic Acid
Treatment: Drugs - Docetaxel

Experimental: Zoledronic Acid -

Active Comparator: Docetaxel -


Treatment: Drugs: Zoledronic Acid


Treatment: Drugs: Docetaxel
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
safety and tolerabilty of adjuvant chemotherapy with docetaxel and Zometa
Timepoint [1] 0 0
6 months after study entry

Eligibility
Key inclusion criteria
- Radical prostatectomy for prostate cancer within last 2 months.

- Post-operative Kattan nomogram predicts >25% risk of PSA relapse by 5 years.

- 6-week post-operative serum PSA<0.2ng/mL.

- Low levels of circulating prostate cancer cells in the blood, detected by PCR
amplification of PSA mRNA 6 weeks post-prostatectomy.
Minimum age
30 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Pre-operative serum PSA level >20ng/ml.

- Clinical evidence of metastases by 6-week post-operative visit.

- Prior treatment with either ADT or bisphosphonate therapy.

- 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)

Other protocol defined inclusion / exclusion criteria may apply.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Radical prostatectomy is used to treat early prostate cancer in otherwise well men, but is
followed by later cancer relapse in 1 in 4 cases. This study aims to see if post-operative
adjuvant therapy with a combination of zoledronic acid and docetaxel might help reduce
relapse in such cases. Patients will be randomized to receive the adjuvant combination
therapy or no therapy. All patients will be monitored closely for signs of relapse and
treated appropriately with conventional salvage therapy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00258765
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00258765