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Androgen Suppression Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With High-Risk Localized Prostate Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), July 2009
First Received: April 1, 2008   Last Updated: July 21, 2009   History of Changes
Sponsors and Collaborators: NCIC Clinical Trials Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00651326
  Purpose

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, leuprolide, buserelin, and goserelin, may lessen the amount of androgens made by the body.

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving androgen suppression therapy together with radiation therapy is more effective with or without docetaxel in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying androgen suppression therapy, radiation therapy, and docetaxel to see how well they work compared with androgen suppression therapy and radiation therapy in treating patients with high-risk localized prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: bicalutamide
Drug: buserelin
Drug: docetaxel
Drug: flutamide
Drug: goserelin
Drug: leuprolide acetate
Procedure: neoadjuvant therapy
Procedure: quality-of-life assessment
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: A Phase III Study of Neoadjuvant Docetaxel and Androgen Suppression Plus Radiation Therapy Versus Androgen Suppression Alone Plus Radiation Therapy for High-Risk Localized Adenocarcinoma of the Prostate (DART)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Time to biochemical disease progression [ Designated as safety issue: No ]
  • Time to local disease progression [ Designated as safety issue: No ]
  • Time to distant disease progression [ Designated as safety issue: No ]
  • Time to next anti-cancer therapy [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Degree of prostate-specific antigen (PSA) suppression prior to radiotherapy [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]

Estimated Enrollment: 530
Study Start Date: March 2008
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To compare disease-free survival rates in patients with high-risk localized adenocarcinoma of the prostate treated with androgen suppression therapy and radiotherapy with vs without docetaxel.

Secondary

  • To compare overall survival.
  • To compare time to biochemical disease progression.
  • To compare time to local disease progression.
  • To compare time to distant disease progression.
  • To compare time to next anticancer therapy.
  • To compare progression-free survival.
  • To compare degree of prostate-specific antigen (PSA) suppression prior to radiotherapy.
  • To compare quality of life (QOL) using EORTC QLQ C30 and EORTC QLQ PR25 questionnaires and a trial-specific checklist.
  • To compare the nature, severity, and frequency of adverse events.

OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (≤ 7 vs ≥ 8), baseline prostate-specific antigen (PSA) (> 20 ng/mL vs ≤ 20 ng/mL), and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive androgen suppression therapy comprising oral flutamide three times daily or oral bicalutamide once daily for 4 weeks AND leuprolide subcutaneously (SC) or intramuscularly every 1-6 months, buserelin SC every 2 or 3 months, or goserelin SC every 1 or 3 months for 3 years. Patients also receive docetaxel IV over 60 minutes on day 1. Treatment with docetaxel repeats every 21 days for up to 4 courses.

Beginning at least 4 weeks after completion of chemotherapy, patients undergo pelvic radiotherapy once daily 5 days a week for up to 8 weeks.

  • Arm II: Patients receive androgen suppression therapy and undergo pelvic radiotherapy as in arm I.

Patients complete quality of life questionnaires at baseline, periodically during treatment, and then every 6 months for 5 years.

After completion of study treatment, patients are followed at 3 and 6 months, every 6 months for 5 years, and then annually thereafter.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Localized (N0, M0) disease
    • No small cell or transitional cell carcinoma in the biopsy specimen
  • Considered to be at high risk for recurrence based on the presence of at least one of the following adverse prognostic features:

    • T stage ≥ 3a
    • Gleason score ≥ 8
    • Baseline prostate-specific antigen (PSA) > 20 ng/mL
  • Deemed to be an appropriate candidate for chemotherapy, as assessed by a medical oncologist
  • Negative pelvic and para-aortic lymph nodes on CT scan or MRI of the abdomen and pelvis

    • Any lymph node appearing ≥ 1.5 cm on CT scan or MRI must be histologically negative by either needle aspirate or lymph node dissection
  • No metastases by chest x-ray and bone scan

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10.0 g/dL
  • AST and/or ALT ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Total bilirubin normal
  • Serum creatinine ≤ 1.5 times ULN
  • Able (i.e., sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of other malignancies, except adequately treated nonmelanoma skin cancer or other curatively treated solid tumor with no evidence of disease for > 5 years
  • No serious non-malignant disease resulting in a life expectancy of < 10 years
  • No known hypersensitivity to any study medications
  • No existing peripheral neuropathy ≥ grade 2
  • No bilateral hip replacement prostheses
  • No contraindication to pelvic radiotherapy including, but not limited to, inflammatory bowel disease or severe bladder irritability
  • No medical condition that would contraindicate the study treatment regimen, including severe respiratory insufficiency, uncontrolled diabetes, or severe hypertension
  • No other serious illness or psychiatric or medical condition that would preclude management of the patient according to the study, including active uncontrolled infection or significant cardiac dysfunction

PRIOR CONCURRENT THERAPY:

  • Prior androgen suppression therapy allowed provided it was initiated no more than 4 weeks prior to study entry
  • At least 4 weeks since prior 5-alpha-reductase inhibitors (e.g., finasteride) for benign prostatic hypertrophy
  • No prior cytotoxic anticancer therapy
  • No prior chemotherapy for carcinoma of the prostate
  • No prior surgical treatment for carcinoma of the prostate, except transurethral resection or bilateral orchiectomy
  • No prior pelvic radiotherapy
  • No concurrent nilutamide
  • No other concurrent investigational drugs
  • No other concurrent anticancer therapy (cytotoxic therapy, biologic/immunotherapy, or radiotherapy)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00651326

Locations
Canada, Alberta
Tom Baker Cancer Centre - Calgary Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: David P. Skarsgard     403-521-3164        
Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Susan Ellard     250-712-3922        
British Columbia Cancer Agency - Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Michael McKenzie     604-877-6000        
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Piotr Czaykowski     204-787-2783        
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Sebastien Hotte     905-387-9495        
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Andrew J. Bayley     416-946-2919        
R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa Recruiting
Oshawa, Ontario, Canada, L1G 2B9
Contact: Wayne Koll     905-576-8711        
Canada, Quebec
McGill Cancer Centre at McGill University Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: M. Tamim Niazi     514-340-8288        
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Study Chair: Michael R. McKenzie, MD, FRCPC British Columbia Cancer Agency
Investigator: Kim N. Chi, MD British Columbia Cancer Agency
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000589247, CAN-NCIC-PR12
Study First Received: April 1, 2008
Last Updated: July 21, 2009
ClinicalTrials.gov Identifier: NCT00651326     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:
Buserelin
Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Goserelin
Urogenital Neoplasms
Genital Diseases, Male
Flutamide
Hormones
Docetaxel
Androgen Antagonists
Leuprolide
Bicalutamide
Adenocarcinoma
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:
Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Reproductive Control Agents
Genital Diseases, Male
Hormones
Pharmacologic Actions
Docetaxel
Androgen Antagonists
Neoplasms
Neoplasms by Site
Leuprolide
Fertility Agents, Female
Therapeutic Uses
Fertility Agents
Bicalutamide
Prostatic Neoplasms
Androgens

ClinicalTrials.gov processed this record on September 11, 2009