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Prostate CancerPhase 3NCT00030654

Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer

A Phase 3 study testing bicalutamide, docetaxel and doxorubicin hydrochloride in people with Prostate Cancer, run by Radiation Therapy Oncology Group at 78 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 120 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
bicalutamide, docetaxel and doxorubicin hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
78 sitesin 4 countries
Study dates
Oct 2002to 4 Feb 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

78 sites in 4 countries.

78 sites in 4 countries

United States75 sites

  • Akron General's McDowell Cancer Center

    Akron, Ohio, 44302

  • Akron City Hospital at Summa Health System

    Akron, Ohio, 44304

  • Veterans Affairs Medical Center - Albuquerque

    Albuquerque, New Mexico, 87108-5138

  • MBCCOP - University of New Mexico HSC

    Albuquerque, New Mexico, 87131

  • Veterans Affairs Medical Center - Amarillo

    Amarillo, Texas, 79106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0010

  • Medical Center of Aurora - South Campus

    Aurora, Colorado, 80012-0000

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231

  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Boulder Community Hospital

    Boulder, Colorado, 80301-9019

  • Veterans Affairs Medical Center - Charleston

    Charleston, South Carolina, 29401-5799

  • Erlanger Cancer Center

    Chattanooga, Tennessee, 37403

  • Veterans Affairs Medical Center - Cincinnati

    Cincinnati, Ohio, 45220-2288

  • Memorial Hospital Cancer Center

    Colorado Springs, Colorado, 80909

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • Mercy Fitzgerald Hospital

    Darby, Pennsylvania, 19023

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428-1002

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • St. Joseph Hospital

    Denver, Colorado, 80218-1191

  • Presbyterian - St. Luke's Medical Center

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers - Denver Rose

    Denver, Colorado, 80220

  • CCOP - Colorado Cancer Research Program, Incorporated

    Denver, Colorado, 80224

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa, 50316-2301

  • Veterans Affairs Medical Center - Detroit

    Detroit, Michigan, 48201-1932

  • Wendt Regional Cancer Center at Finley Hospital

    Dubuque, Iowa, 52001

  • Swedish Medical Center

    Englewood, Colorado, 80112

  • Shands Cancer Center at the University of Florida Health Science Center

    Gainesville, Florida, 32610-0385

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0209

  • CCOP - Southeast Cancer Control Consortium

    Goldsboro, North Carolina, 27534-9479

  • CCOP - St. Vincent Hospital Cancer Center, Green Bay

    Green Bay, Wisconsin, 54301

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Veterans Affairs Medical Center - Hines

    Hines, Illinois, 60141

  • Veterans Affairs Medical Center - Jackson

    Jackson, Mississippi, 39216

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Veterans Affairs Medical Center - Lexington

    Lexington, Kentucky, 40502-2236

  • Veterans Affairs Medical Center - Little Rock

    Little Rock, Arkansas, 72205

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Hope Cancer Care Center at Longmont United Hospital

    Longmont, Colorado, 80501

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • Veterans Affairs Outpatient Clinic - Martinez

    Martinez, California, 94553

  • Veterans Affairs Medical Center - Memphis

    Memphis, Tennessee, 38104

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

    Nashville, Tennessee, 37232-5671

  • Veterans Affairs Medical Center - New Orleans

    New Orleans, Louisiana, 70112

  • NYU School of Medicine's Kaplan Comprehensive Cancer Center

    New York, New York, 10016

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Gulf Coast Cancer Treatment Center

    Panama City, Florida, 32405-4587

  • Midlands Cancer Center at Midlands Community Hospital

    Papillion, Nebraska, 68128-4157

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Foundation for Cancer Research and Education

    Phoenix, Arizona, 85013

  • Veterans Affairs Medical Center - Portland

    Portland, Oregon, 97207

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • St. Mary-Corwin Regional Medical Center

    Pueblo, Colorado, 81004

  • All Saints Cancer Center at All Saints Healthcare

    Racine, Wisconsin, 53405

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57709

  • Lipson Cancer and Blood Center at Rochester General Hospital

    Rochester, New York, 14621

  • Cancer Care Center, Incorporated

    Salem, Ohio, 44460

  • Veterans Affairs Medical Center - Salt Lake City

    Salt Lake City, Utah, 84148

  • Veterans Affairs Medical Center - San Antonio (Murphy)

    San Antonio, Texas, 78229

  • Mercy Hospital Cancer Center - Scranton

    Scranton, Pennsylvania, 18501

  • Veterans Affairs Medical Center - Seattle

    Seattle, Washington, 98108

  • Veterans Affairs Medical Center - Shreveport

    Shreveport, Louisiana, 71101-4295

  • Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • Dixie Regional Medical Center

    St. George, Utah, 84770

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • Veterans Affairs Medical Center - Tampa (Haley)

    Tampa, Florida, 33612

  • Veterans Affairs Medical Center - Temple

    Temple, Texas, 76504

  • Rocky Mountain Cancer Centers - Thornton

    Thornton, Colorado, 80221

  • Veterans Affairs Medical Center - Tucson

    Tucson, Arizona, 85723

  • Veterans Affairs Medical Center - Wichita

    Wichita, Kansas, 67218

  • Cancer Treatment Center

    Wooster, Ohio, 44691

Other trials in United States

Australia1 site

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Peru1 site

  • Instituto de Enfermedades Neoplasicas

    Lima, 34

Other trials in Peru

Puerto Rico1 site

  • San Juan City Hospital

    San Juan, 00936-7344

Other trials in Puerto Rico

About this study

Official title: A Phase III Randomized Study of Patients With High Risk, Hormone-Naive Prostate Cancer: Androgen Blockade With 4 Cycles of Immediate Chemotherapy Versus Androgen Blockade With Delayed Chemotherapy

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.

Read the detailed description

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
Prostate Cancer
Being tested
bicalutamide, docetaxel, doxorubicin hydrochloride, estramustine phosphate sodium, flutamide
Keywords
adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00030654
Study groupRoleWhat they receive
Androgen blockade + immediate chemotherapyExperimentalAndrogen blockade with immediate chemotherapy
Receives: Drug: bicalutamide; Drug: docetaxel; Drug: doxorubicin hydrochloride; Drug: estramustine phosphate sodium; Drug: flutamide; Drug: ketoconazole; Drug: paclitaxel; Drug: releasing hormone agonist therapy; Drug: vinblastine sulfate
Androgen blockade + delayed chemotherapyExperimentalAndrogen blockade with delayed chemotherapy
Receives: Drug: bicalutamide; Drug: docetaxel; Drug: doxorubicin hydrochloride; Drug: estramustine phosphate sodium; Drug: flutamide; Drug: ketoconazole; Drug: paclitaxel; Drug: releasing hormone agonist therapy; Drug: vinblastine sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Measured: From date of randomization to the date of death due to any cause

Secondary outcomes (3)

  1. Biochemical control

    Measured: From date of randomization to the date of first PSA failure defined as a PSA doubling time <= 32 weeks

  2. Time to Clinical Failure

    Measured: Time from study entry to positive scan or positive disease evaluation of the pelvis or chest or a PSA doubling time ≤ 32 weeks

  3. Frequency of non-hematologic (>= grade 3), hematologic (grade >=4) and fatal (grade 5) toxicities

    Measured: From the beginning of treatment to 90 days post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startOct 2002
  3. Primary completion4 Feb 2005
  4. Study completion4 Feb 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00030654
Sponsor's protocol ID
RTOG-P-0014
Other IDs
CDR0000069186, ECOG-RTOG-P-0014, CALGB-RTOG-P-0014, SWOG-RTOG-P-0014
Status last verified
Mar 2017
First submitted
14 Feb 2002
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Sandler HM, Pienta KJ. Rationale for the Radiation Therapy Oncology Group Study RTOG P-0014. Rev Urol. 2003;5 Suppl 2(Suppl 2):S28-34.

    PubMed 16986043

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bicalutamide, docetaxel and doxorubicin hydrochloride in people with Prostate Cancer, run by Radiation Therapy Oncology Group at 78 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, Australia, Peru, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: From date of randomization to the date of death due to any cause). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00030654, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.

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