Adjuvant Docetaxel-Zoledronic Acid in High-risk Early Prostate Cancer Following Prostatectomy.

Back to results

Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

Australia

Study Type

Interventional

Intervention

Zoledronic Acid

Docetaxel

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring zoledronic acid, prostate cancer, high risk, PSA, docetaxel

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Zoledronic Acid

Docetaxel

Arm Description

Outcomes

Primary Outcome Measures

safety and tolerabilty of adjuvant chemotherapy with docetaxel and Zometa

Secondary Outcome Measures

Full Information

NCT ID

NCT00258765

First Posted

November 24, 2005

Last Updated

April 23, 2010

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00258765

Brief Title

Adjuvant Docetaxel-Zoledronic Acid in High-risk Early Prostate Cancer Following Prostatectomy.

Official 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).

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Terminated

Why Stopped

Poor recruitment & not feasible to continue

Study Start Date

May 2006 (undefined)

Primary Completion Date

November 2006 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

zoledronic acid, prostate cancer, high risk, PSA, docetaxel

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zoledronic Acid

Arm Type

Experimental

Arm Title

Docetaxel

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Zoledronic Acid

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Primary Outcome Measure Information:

Title

safety and tolerabilty of adjuvant chemotherapy with docetaxel and Zometa

Time Frame

6 months after study entry

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Sydney

Country

Australia

12. IPD Sharing Statement

Links:

URL

http://www.novartisclinicaltrials.com/etrials/searchTrial.do?trialID=717

Description

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

Prostate Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial