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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Zoledronic Acid

Group Type EXPERIMENTAL

Zoledronic Acid

Intervention Type DRUG

Docetaxel

Group Type ACTIVE_COMPARATOR

Docetaxel

Intervention Type DRUG

Interventions

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Zoledronic Acid

Intervention Type DRUG

Docetaxel

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No