Home
Clinical Trials
Hormone Therapy Plus Chemothe...

Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer

Last Updated: 2020-10-22

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2005-02-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as luteinizing hormone-releasing hormone agonist, flutamide, and bicalutamide may stop the adrenal glands from producing androgens. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy given at the same time as hormone therapy is more effective than chemotherapy given after hormone therapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy given at the same time as hormone therapy with that of chemotherapy given after hormone therapy in treating patients who have prostate cancer.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer

NCT00004054

Prostate Cancer

COMPLETED PHASE3

Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer

NCT00002855

Prostate Cancer

COMPLETED PHASE3

S0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer

NCT00028769

Prostate Cancer

COMPLETED PHASE2

Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence

NCT00003645

Prostate Cancer

TERMINATED PHASE3

Hormone Therapy Compared With Combination Chemotherapy in Treating Patients With Prostate Cancer

NCT00027859

Prostate Cancer

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

OBJECTIVES:

Primary

* Compare the survival of patients with high-risk hormone-naive prostate cancer treated with androgen blockade with concurrent chemotherapy vs delayed chemotherapy.

Secondary

* Compare biochemical control in patients treated with these regimens.
* Determine the toxicity of these regimens in these patients.
* Compare the time to clinical failure, as measured by progression on bone scan or CT scan or a prostate-specific antigen (PSA) doubling time of ≤ 32 weeks, in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior therapy (surgery vs radiotherapy and/or brachytherapy vs both), original combined Gleason score (6 vs 7 vs 8-10), and prior vaccine therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive androgen blockade (AB) comprising a luteinizing-hormone releasing-hormone agonist continuously and oral flutamide or oral bicalutamide once daily for at least 1 month. Within 4 weeks of initiation of AB, patients begin chemotherapy. Patients receive 1, and only 1, of the following chemotherapy regimens:

* Regimen A: Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV on day 3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
* Regimen B: Patients receive oral estramustine 3 times daily on days 1-5 and paclitaxel IV on days 3, 10, 17, 24, 31, and 38. Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity.
* Regimen C: Patients receive oral ketoconazole 3 times daily on days 1-7, 15-21, and 29-35; doxorubicin IV on days 1, 15, and 29; vinblastine IV on days 8, 22, and 36; and oral estramustine 3 times daily on days 8-14, 22-28, and 36-42. Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity.
* Regimen D: Patients receive oral estramustine 3 times daily on days 1-4 and docetaxel IV over 1 hour on days 3, 10, and 17. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
* Regimen E: Patients receive docetaxel IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
* Regimen F: Patients receive docetaxel IV on days 1, 8, and 15. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
* Regimen G: With approval from the protocol chair, patients may receive a regimen that has been demonstrated in a published phase II study to have at least a 50% response rate as measured by PSA decrease from baseline over 2 measurements 28 days apart or a decrease in measurable soft tissue disease by 50% in 2 dimensions.
* Arm II: Patients receive AB as in arm I. Patients continue with AB until clinical failure, at which time patients receive chemotherapy as in arm I. Patients who have a response may continue to receive chemotherapy beyond 4 courses.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,050 patients will be accrued for this study within 4-6 years.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Androgen blockade + immediate chemotherapy

Androgen blockade with immediate chemotherapy

Group Type EXPERIMENTAL

bicalutamide

Intervention Type DRUG

docetaxel

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

estramustine phosphate sodium

Intervention Type DRUG

flutamide

Intervention Type DRUG

ketoconazole

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

releasing hormone agonist therapy

Intervention Type DRUG

vinblastine sulfate

Intervention Type DRUG

Androgen blockade + delayed chemotherapy

Androgen blockade with delayed chemotherapy

Group Type EXPERIMENTAL

bicalutamide

Intervention Type DRUG

docetaxel

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

estramustine phosphate sodium

Intervention Type DRUG

flutamide

Intervention Type DRUG

ketoconazole

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

releasing hormone agonist therapy

Intervention Type DRUG

vinblastine sulfate

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

bicalutamide

Intervention Type DRUG

docetaxel

Intervention Type DRUG

doxorubicin hydrochloride

Intervention Type DRUG

estramustine phosphate sodium

Intervention Type DRUG

flutamide

Intervention Type DRUG

ketoconazole

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

releasing hormone agonist therapy

Intervention Type DRUG

vinblastine sulfate

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

DISEASE CHARACTERISTICS:

* Diagnosis of adenocarcinoma of the prostate

* Failed local treatments (surgery and/or radiotherapy and/or brachytherapy) as defined by a rising prostate-specific antigen level of at least 2.0 ng/mL (confirmed by 2 measurements at least 2 weeks apart) and a doubling time of 32 weeks or less
* No clinical or radiographic evidence of disease
* Original Gleason score of at least 7 OR Gleason score of 6 with capsular penetration or positive seminal vesicles or lymph nodes
* No metastases

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Zubrod 0-1

Life expectancy:

* Not specified

Hematopoietic:

* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL
* No history of bleeding disorders that would contraindicate warfarin, including clotting factor defects

Hepatic:

* Bilirubin no greater than 1.5 mg/dL
* AST/ALT no greater than 1.5 times upper limit of normal

Renal:

* Creatinine no greater than 1.5 mg/dL
* Blood Urea Nitrogen (BUN) no greater than 1.2 times normal

Cardiovascular:

* No symptomatic heart disease
* No history of myocardial infarction
* No history of thromboembolic events (e.g., deep vein thrombosis, symptomatic cerebrovascular events, or pulmonary embolism)

Other:

* No other major medical or psychiatric illness that would preclude study entry
* No other prior or concurrent invasive malignancy within the past 5 years except superficial skin cancer
* No history of esophageal varices
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 6 weeks since prior vaccine therapy

Chemotherapy:

* At least 5 years since prior chemotherapy

Endocrine therapy:

* Prior adjuvant or neoadjuvant hormonal therapy of less than 8 months duration allowed
* At least 1 year since prior androgen therapy

Radiotherapy:

* See Disease Characteristics
* At least 5 years since prior radiotherapy to sites other than prostate

Surgery:

* See Disease Characteristics

Other:

* Concurrent warfarin allowed
* Concurrent bisphosphonate therapy initiated prior to or after randomization allowed

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kenneth J. Pienta, MD, FACP

Role: STUDY_CHAIR

University of Michigan Rogel Cancer Center

Naomi S. Balzer-Haas, MD

Role: STUDY_CHAIR

Fox Chase Cancer Center

Arif Hussain, MD

Role: STUDY_CHAIR

University of Maryland Greenebaum Cancer Center

Gregory P. Swanson, MD

Role: STUDY_CHAIR

Deaconess Medical Center, Spokane, Washington

Primo N. Lara, MD

Role: STUDY_CHAIR

University of California, Davis

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Foundation for Cancer Research and Education

Phoenix, Arizona, United States

Site Status

Veterans Affairs Medical Center - Tucson

Tucson, Arizona, United States

Site Status

Veterans Affairs Medical Center - Little Rock

Little Rock, Arkansas, United States

Site Status

Veterans Affairs Outpatient Clinic - Martinez

Martinez, California, United States

Site Status

Medical Center of Aurora - South Campus

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status

Memorial Hospital Cancer Center

Colorado Springs, Colorado, United States

Site Status