Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00186420

Enrollment

Registered

2005-09-16

Start date

2003-07-31

Completion date

2009-09-30

Last updated

2012-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate Cancer, Taxotere

Brief summary

The purpose of this study is to evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.

Interventions

DRUGTaxotere

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients who have undergone a radical prostatectomy (should have unmeasurable PSA) or radiation therapy for prostate cancer and who have high risk disease as defined by one of the following: * Node positive disease post-operatively * Capsule involvement * Seminal Vesicles involvement * Gleason score ≥ 8 * \>50% of core biopsies that are positive * Clinical Stage T2c and T3 * Pre-op PSA \> 15 plus Gleason score of 7 * Age greater than 18 * ECOG Performance Status 0-1 * Serum creatinine \<= 1.5 mg/dl * Granulocyte count \>= 1500/m3, Hemoglobin \> 8.0 g/dl, and platelet count \>= 100,000/m3 * Total bilirubin \<= ULN * AST, ALT and Alkaline Phosphatase must be within the range allowing for eligibility. * Signed patient informed consent. * Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for three months thereafter.

Exclusion criteria

* Peripheral neuropathy \> grade 1 * History of severe hypersensitivity to Taxotere® or other drugs formulated with polysorbate 80. * Patients who have received previous chemotherapy or are being treated on another clinical trial using an investigational agent. * Active infection within 14 days of beginning treatment * Patients with a serious illness or medical condition, history of significant neurologic or psychiatric or active infection. * Patients with a current malignancy. Patients with prior a history of in situ lobular carcinoma of the breast, basal or squamous cell skin cancer, are eligible.

Design outcomes

Primary

Measure	Time frame
To evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.	Following treatment

Secondary

Measure	Time frame
To evaluate the toxicity of taxotere and hormones given adjuvantly.	Following treatment
To measure Quality of Life on this therapy.	Following treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026