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ACTIVE NOT RECRUITING

NCT00430183

PHASE3

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

Sponsor: Alliance for Clinical Trials in Oncology

View on ClinicalTrials.gov

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.

Official title: A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

788

Start Date

2007-05-08

Completion Date

2030-10

Last Updated

2023-02-09

Healthy Volunteers

Conditions

Prostate Cancer

Interventions

DRUG

docetaxel

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

DRUG

LHRH agonist

Given intramuscularly

PROCEDURE

surgery

Patients undergo radical prostatectomy with staging pelvic lymphadenectomy.

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

Locations (226)

Providence Cancer Center

Anchorage, Alaska, United States

Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Alta Bates Summit Comprehensive Cancer Center

Berkeley, California, United States

Peninsula Medical Center

Burlingame, California, United States

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Sutter Health - Western Division Cancer Research Group

Novato, California, United States

University of California Davis Cancer Center

Sacramento, California, United States

Naval Medical Center - San Diego

San Diego, California, United States

California Pacific Medical Center - Pacific Campus

San Francisco, California, United States

Sutter Pacific Medical Foundation

Santa Rosa, California, United States

Tahoe Forest Cancer Center

Truckee, California, United States

Sutter Solano Medical Center

Vallejo, California, United States

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, United States

Denver Health Medical Center

Denver, Colorado, United States

Veterans Affairs Medical Center - Denver

Denver, Colorado, United States

Shaw Regional Cancer Center

Edwards, Colorado, United States

Valley View Hospital Cancer Center

Glenwood Springs, Colorado, United States

Montrose Memorial Hospital Cancer Center

Montrose, Colorado, United States

Helen and Harry Gray Cancer Center at Hartford Hospital

Hartford, Connecticut, United States

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Yale Cancer Center

New Haven, Connecticut, United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

Veterans Affairs Medical Center - West Haven

West Haven, Connecticut, United States

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, United States

CCOP - Christiana Care Health Services

Newark, Delaware, United States

Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

Fort Lauderdale, Florida, United States

Ella Milbank Foshay Cancer Center at Jupiter Medical Center

Jupiter, Florida, United States

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, United States

Florida Hospital Cancer Institute at Florida Hospital Orlando

Orlando, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, United States

Cleveland Clinic Florida - Weston

Weston, Florida, United States

OnCare Hawaii, Incorporated - Lusitana