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Clinical Trials in Canada / NCT00430183
Active, not recruiting Phase 3

Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer

NCT00430183 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2007-05-08
Last updated
2023-02-09

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

docetaxel →LHRH agonistsurgery

docetaxel: 75 mg/m\^2 will be administered intravenously over one hour on Day 1 of each cycle, every 21 days

LHRH agonist: Given intramuscularly

surgery: Patients undergo radical prostatectomy with staging pelvic lymphadenectomy.

Study summary

RATIONALE: 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. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and leuprolide, may stop the adrenal glands from making androgens. Giving docetaxel and leuprolide or goserelin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether giving docetaxel and leuprolide or goserelin before surgery is more effective than surgery alone in treating patients with prostate cancer.

PURPOSE: This randomized phase III trial is studying docetaxel and leuprolide or goserelin to see how well they work when given before surgery compared with surgery alone in treating patients with high-risk localized prostate cancer.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
1. Histologic documentation - Histologic documentation of prostatic adenocarcinoma. Patients with small cell, neuroendocrine, or transitional cell carcinomas are not eligible. All eligible patients must have a known Gleason sum based on biopsy or TURP at the time of registration. 2. Clinically localized disease - Patients must have clinical stage T1-T3a and no radiographic evidence of metastatic disease as demonstrated by: * EITHER CT or MRI of the abdomen and pelvis, OR endorectal MRI of the pelvis that demonstrate no nodes \> 1.5 cm. If one or more pelvic lymph node(s) measures \> 1.5 cm, a negative biopsy is required. If more than one lymph node is \> 1.5 cm, the largest or most accessible node should be biopsied. AND * Negative bone scan (with plain films and/or MRI and/or CT scan confirmation, if necessary). Positive PET and Prostascint scans are not considered proof of metastatic disease. 3. Determination of high-risk status: Patients must have either: * A Kattan nomogram predicted probability of being free from biochemical progression at 5 years after surgery of \< 60%. OR * Prostate biopsy Gleason sum ≥ 8 (NOTE: The Kattan nomogram probability must be calculated for all patients, including those eligible based on Gleason sum ≥ 8 only.) 4. Prior treatment - No prior treatment for prostate cancer including prior surgery (excluding TURP), pelvic lymph node dissection, radiation therapy, or chemotherapy. Patients may have received up to 4 months of androgen deprivation therapy (LHRH agonists, antiandrogens, or both) prior to being enrolled on the study. 5. Appropriate surgical candidates - Patients must be appropriate candidates for radical prostatectomy with an estimated life expectancy \> 10 years as determined by a urologist. Evidence of underlying cardiac disease should be evaluated prior to enrollment to ensure that patients are not at high risk of cardiac complications. 6. Clotting history - Patients with a history of deep venous thrombosis, pulmonary embolism, and/or cerebrovascular accident or currently requiring systemic anticoagulation are eligible provided they are determined to be candidates for radical prostatectomy. 7. ECOG performance status: 0-2 8. Age: ≥ 18 years of age 9. Required Initial Laboratory Values: * ANC ≥ 1500/μL * Platelet count ≥ 150,000/μL * Creatinine ≤ 2.0 mg/dL * Pre-registration serum PSA level ≤ 100 ng/mL * Bilirubin ≤ 1.5XULN (2.5XULN in patients with Gilbert's disease) * AST/ALT ≤1.5XULN

Primary outcome measure(s)

Trial sites (226)

FacilityCityRegionStatus
Providence Cancer Center Anchorage Alaska
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital Fairbanks Alaska
Alta Bates Summit Comprehensive Cancer Center Berkeley California
Peninsula Medical Center Burlingame California
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California
Sutter Health - Western Division Cancer Research Group Novato California
University of California Davis Cancer Center Sacramento California
Naval Medical Center - San Diego San Diego California
California Pacific Medical Center - Pacific Campus San Francisco California
Sutter Pacific Medical Foundation Santa Rosa California
Tahoe Forest Cancer Center Truckee California
Sutter Solano Medical Center Vallejo California
University of Colorado Cancer Center at UC Health Sciences Center Aurora Colorado
Denver Health Medical Center Denver Colorado
Veterans Affairs Medical Center - Denver Denver Colorado
Shaw Regional Cancer Center Edwards Colorado
Valley View Hospital Cancer Center Glenwood Springs Colorado
Montrose Memorial Hospital Cancer Center Montrose Colorado
Helen and Harry Gray Cancer Center at Hartford Hospital Hartford Connecticut
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford Connecticut
Yale Cancer Center New Haven Connecticut
Eastern Connecticut Hematology and Oncology Associates Norwich Connecticut
Veterans Affairs Medical Center - West Haven West Haven Connecticut
Tunnell Cancer Center at Beebe Medical Center Lewes Delaware
CCOP - Christiana Care Health Services Newark Delaware
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Fort Lauderdale Florida
Ella Milbank Foshay Cancer Center at Jupiter Medical Center Jupiter Florida
CCOP - Mount Sinai Medical Center Miami Beach Florida
Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Tampa Florida
Cleveland Clinic Florida - Weston Weston Florida
OnCare Hawaii, Incorporated - Lusitana Honolulu Hawaii
Queen's Cancer Institute at Queen's Medical Center Honolulu Hawaii
Straub Clinic and Hospital, Incorporated Honolulu Hawaii
Hawaii Medical Center - East Honolulu Hawaii
OnCare Hawaii, Incorporated - Kuakini Honolulu Hawaii
Kapiolani Medical Center for Women and Children Honolulu Hawaii
Castle Medical Center Kailua Hawaii
Kauai Medical Clinic Lihue Hawaii
Maui Memorial Medical Center Wailuku Hawaii

+ 186 more sites — see the full list on the official registry below.

More Alliance for Clinical Trials in Oncology trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT00430183 on ClinicalTrials.gov ↗ ← All trials in Canada