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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).


Phase 2
30 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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).


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.

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

safety and tolerabilty of adjuvant chemotherapy with docetaxel and Zometa

Outcome Time Frame:

6 months after study entry

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

CZOL446GAU15

NCT ID:

NCT00258765

Start Date:

May 2006

Completion Date:

Related Keywords:

  • Prostate Cancer
  • zoledronic acid
  • prostate cancer
  • high risk
  • PSA
  • docetaxel
  • Prostatic Neoplasms

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