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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00030654




Registration number
NCT00030654
Ethics application status
Date submitted
14/02/2002
Date registered
27/01/2003
Date last updated
10/03/2017

Titles & IDs
Public title
Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer
Scientific 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
Secondary ID [1] 0 0
CDR0000069186
Secondary ID [2] 0 0
RTOG-P-0014
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - bicalutamide
Treatment: Drugs - docetaxel
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Drugs - estramustine phosphate sodium
Treatment: Drugs - flutamide
Treatment: Drugs - ketoconazole
Treatment: Drugs - paclitaxel
Treatment: Drugs - releasing hormone agonist therapy
Treatment: Drugs - vinblastine sulfate

Experimental: Androgen blockade + immediate chemotherapy - Androgen blockade with immediate chemotherapy

Experimental: Androgen blockade + delayed chemotherapy - Androgen blockade with delayed chemotherapy


Treatment: Drugs: bicalutamide


Treatment: Drugs: docetaxel


Treatment: Drugs: doxorubicin hydrochloride


Treatment: Drugs: estramustine phosphate sodium


Treatment: Drugs: flutamide


Treatment: Drugs: ketoconazole


Treatment: Drugs: paclitaxel


Treatment: Drugs: releasing hormone agonist therapy


Treatment: Drugs: vinblastine sulfate


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
From date of randomization to the date of death due to any cause
Secondary outcome [1] 0 0
Biochemical control
Timepoint [1] 0 0
From date of randomization to the date of first PSA failure defined as a PSA doubling time <= 32 weeks
Secondary outcome [2] 0 0
Time to Clinical Failure
Timepoint [2] 0 0
Time from study entry to positive scan or positive disease evaluation of the pelvis or chest or a PSA doubling time = 32 weeks
Secondary outcome [3] 0 0
Frequency of non-hematologic (>= grade 3), hematologic (grade >=4) and fatal (grade 5) toxicities
Timepoint [3] 0 0
From the beginning of treatment to 90 days post treatment

Eligibility
Key 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 age
18 Years
Maximum age
120 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
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United States of America
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Colorado
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Florida
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United States of America
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Idaho
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Illinois
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Iowa
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United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Michigan
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Mississippi
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United States of America
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Missouri
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United States of America
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Nebraska
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United States of America
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New Mexico
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United States of America
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New York
Country [19] 0 0
United States of America
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North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
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South Carolina
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United States of America
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South Dakota
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United States of America
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Tennessee
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Texas
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United States of America
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Utah
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United States of America
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Washington
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United States of America
State/province [29] 0 0
Wisconsin
Country [30] 0 0
Peru
State/province [30] 0 0
Lima
Country [31] 0 0
Puerto Rico
State/province [31] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Other
Name
Radiation Therapy Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Eastern Cooperative Oncology Group
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Cancer and Leukemia Group B
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Southwest Oncology Group
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
NRG Oncology
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief 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. 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.
Trial website
https://clinicaltrials.gov/show/NCT00030654
Trial related presentations / publications
Sandler HM, Pienta KJ. Rationale for the Radiation Therapy Oncology Group Study RTOG P-0014. Rev Urol. 2003;5 Suppl 2:S28-34.
Public notes

Contacts
Principal investigator
Name 0 0
Kenneth J. Pienta, MD, FACP
Address 0 0
University of Michigan Rogel Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications