Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy

NCT ID: NCT00528866

Last Updated: 2019-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2018-05-14

Brief Summary

RATIONALE: Specialized radiation therapy that delivers a high-dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide, goserelin, flutamide, or bicalutamide, may lessen the amount of androgens made by the body. 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. Giving radiation therapy together with androgen suppression and docetaxel after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well giving radiation therapy together with androgen suppression and docetaxel works in treating patients with high risk prostate cancer who have undergone radical prostatectomy.

Detailed Description

OBJECTIVES:

Primary

• To assess whether the addition of androgen suppression therapy and docetaxel to adjuvant radiotherapy improves freedom from progression.

Secondary

• To assess freedom from local-regional progression, distant metastases, disease-free survival, prostate cancer specific survival, non-prostate cancer specific survival, overall survival, and time to biochemical (PSA) failure.
• To evaluate treatment-related "acute" and "late" toxicity based on Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0.
• To correlate genomic and proteomic biomarkers with the primary and secondary clinical endpoints utilizing archival prostatectomy tissue and pretreatment and prospectively collected serum/plasma.

OUTLINE: This is a multicenter study.

• Androgen suppression therapy: Patients receive a luteinizing hormone-releasing hormone (LHRH) agonist (leuprolide or goserelin) as an injection AND an oral antiandrogen (flutamide 3 times daily or bicalutamide once daily) for up to 6 months.
• Radiotherapy: Beginning 8 weeks after the initiation of androgen suppression therapy, patients undergo 3-dimensional conformal radiotherapy or intensity-modulated radiotherapy once a day 5 days a week for up to approximately 8 weeks.
• Chemotherapy: Beginning 3-6 weeks after the completion of radiotherapy, patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses.

After the completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Androgen suppression + RT + docetaxel

LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel

Group Type: EXPERIMENTAL

bicalutamide

Intervention Type: DRUG

50 mg (one tablet) daily orally for 6 months, starting within 6 months after registration

docetaxel

Intervention Type: DRUG

75 mg/m2 IV over 1 hour on day 1 of each cycle q21 days for 6 cycles, starting 3-6 weeks after completion of radiation therapy

flutamide

Intervention Type: DRUG

250 mg (two 125-mg capsules) three times daily (total 750 mg) orally for 6 months, starting within 6 months after registration

LHRH agonist

Intervention Type: DRUG

LHRH agonist (such as leuprolide, goserelin, buserelin, or triptorelin) for 6 months, starting within 6 weeks after registration

3-dimensional conformal radiation therapy

Intervention Type: RADIATION

radiation therapy

Intervention Type: RADIATION

66.6 Gy (1.8 Gy per fraction, 5 days per week) to the prostate bed (IMRT or 3DCRT), starting 8 weeks after start of hormones

Interventions

bicalutamide

50 mg (one tablet) daily orally for 6 months, starting within 6 months after registration

Intervention Type: DRUG

docetaxel

75 mg/m2 IV over 1 hour on day 1 of each cycle q21 days for 6 cycles, starting 3-6 weeks after completion of radiation therapy

Intervention Type: DRUG

flutamide

250 mg (two 125-mg capsules) three times daily (total 750 mg) orally for 6 months, starting within 6 months after registration

Intervention Type: DRUG

LHRH agonist

LHRH agonist (such as leuprolide, goserelin, buserelin, or triptorelin) for 6 months, starting within 6 weeks after registration

Intervention Type: DRUG

3-dimensional conformal radiation therapy

Intervention Type: RADIATION

radiation therapy

66.6 Gy (1.8 Gy per fraction, 5 days per week) to the prostate bed (IMRT or 3DCRT), starting 8 weeks after start of hormones

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Pathologically proven adenocarcinoma of the prostate gland meeting one of the following criteria:

• Gleason ≥ 7and post-operative PSA nadir > 0.2 ng/ml with any pathologic tumor (pT) classification
• Gleason ≥ 8, post-operative PSA nadir ≤ 0.2 ng/ml and ≥ pT3a classification
• Must have undergone radical prostatectomy within the past year
• PSA must be obtained within 6 weeks (42 days) prior to study registration
• No lymph node or distant metastases (N0, M0), based upon the following minimum diagnostic workup:

• History and physical examination within 8 weeks prior to study registration
• Bone scan and CT or MRI of the pelvis and no evidence of osseous metastases on bone scan within 16 weeks prior to study registration
• No pelvic lymph nodes > 1.5 cm in greatest dimension on CT scan or MRI of the pelvis within 16 weeks prior to study registration, unless the enlarged lymph node is biopsied and negative

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-1
• Absolute neutrophil count (ANC) ≥ 2,000/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL is acceptable)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• Total bilirubin ≤ 1.2 times ULN
• No other invasive malignancy within the past 3 years except non-melanomatous skin cancer
• No active, severe co-morbidity, including any of the following:

• Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
• Transmural myocardial infarction within the past 6 months
• Acute bacterial or fungal infection requiring intravenous antibiotics
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy
• AIDS

• HIV testing is not required for study entry
• No prior allergic reaction to the study drug(s)

PRIOR CONCURRENT THERAPY:

• No prior systemic chemotherapy for prostate cancer
• More than 3 years since prior chemotherapy for a different cancer
• No prior androgen deprivation for treatment of prostate cancer

• Prior use of hormonal agents, such as finasteride or dutasteride, for treatment of benign prostatic hypertrophy is allowed
• No prior radiotherapy to the region of the prostate that would result in overlap of radiotherapy fields

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

NRG Oncology

OTHER

Sponsor Role: collaborator

Radiation Therapy Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Hurwitz, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University and Hospitals

Oliver Sartor, MD

Role: STUDY_CHAIR

Dana-Farber Cancer Institute

Ying Xiao, PhD

Role: STUDY_CHAIR

Bodine Center for Cancer Treatment at Thomas Jefferson University Hospital

Locations

Arizona Oncology Services Foundation

Phoenix, Arizona, United States

Auburn Radiation Oncology

Auburn, California, United States

Radiation Oncology Centers - Cameron Park

Cameron Park, California, United States

Mercy Cancer Center at Mercy San Juan Medical Center

Carmichael, California, United States

Radiation Oncology Center - Roseville

Roseville, California, United States

Radiological Associates of Sacramento Medical Group, Incorporated

Sacramento, California, United States

Mercy General Hospital

Sacramento, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Solano Radiation Oncology Center

Vacaville, California, United States

Urology Center of Colorado

Denver, Colorado, United States

Poudre Valley Radiation Oncology

Fort Collins, Colorado, United States

CCOP - Christiana Care Health Services

Newark, Delaware, United States

Cancer Institute at St. John's Hospital

Springfield, Illinois, United States

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Norton Suburban Hospital

Louisville, Kentucky, United States

Tulane Cancer Center Office of Clinical Research

Alexandria, Louisiana, United States

Mary Bird Perkins Cancer Center - Baton Rouge

Baton Rouge, Louisiana, United States

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, United States

CCOP - Ochsner

New Orleans, Louisiana, United States

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Hudner Oncology Center at Saint Anne's Hospital - Fall River

Fall River, Massachusetts, United States

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, United States

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, United States

Minnesota Oncology Hematology, PA - Maplewood

Maplewood, Minnesota, United States

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

Minneapolis, Minnesota, United States

Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

Robbinsdale, Minnesota, United States

CentraCare Clinic - River Campus

Saint Cloud, Minnesota, United States

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, United States

United Hospital

Saint Paul, Minnesota, United States

Ridgeview Medical Center

Waconia, Minnesota, United States

Regional Cancer Center at Singing River Hospital

Pascagoula, Mississippi, United States

Cancer Institute of Cape Girardeau, LLC

Cape Girardeau, Missouri, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, United States

Nevada Cancer Institute

Las Vegas, Nevada, United States

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

Marlton, New Jersey, United States

Newark Beth Israel Medical Center

Newark, New Jersey, United States

University Medical Center at Princeton

Princeton, New Jersey, United States

Mission Hospitals - Memorial Campus

Asheville, North Carolina, United States

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, United States

Wayne Radiation Oncology

Goldsboro, North Carolina, United States

Pardee Memorial Hospital

Hendersonville, North Carolina, United States

Cancer Centers of North Carolina - Raleigh

Raleigh, North Carolina, United States

Forsyth Regional Cancer Center at Forsyth Medical Center

Winston-Salem, North Carolina, United States

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Summa Center for Cancer Care at Akron City Hospital

Akron, Ohio, United States

Barberton Citizens Hospital

Barberton, Ohio, United States

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, United States

Cancer Care Center, Incorporated

Salem, Ohio, United States

Precision Radiotherapy at University Pointe

West Chester, Ohio, United States

Cancer Treatment Center

Wooster, Ohio, United States

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, United States

Integris Oncology Services

Oklahoma City, Oklahoma, United States

St. Luke's Cancer Network at St. Luke's Hospital

Bethlehem, Pennsylvania, United States

Delaware County Regional Cancer Center at Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, United States

Fox Chase Cancer Center Buckingham

Furlong, Pennsylvania, United States

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center CCOP Research Base

Philadelphia, Pennsylvania, United States

Crozer-Chester Medical Center

Upland, Pennsylvania, United States

CCOP - Upstate Carolina

Spartanburg, South Carolina, United States

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

Murray, Utah, United States

CCOP - Virginia Mason Research Center

Seattle, Washington, United States

Community Memorial Hospital Cancer Care Center

Menomonee Falls, Wisconsin, United States

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, United States

McGill Cancer Centre at McGill University

Montreal, Quebec, Canada

Countries

United States; Canada

Other Identifiers

CDR0000563917

Identifier Type: -

Identifier Source: secondary_id

NCI-2009-00740

Identifier Type: REGISTRY

Identifier Source: secondary_id

RTOG-0621

Identifier Type: -

Identifier Source: org_study_id