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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00528866
First received: September 10, 2007
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: bicalutamide
Drug: docetaxel
Drug: flutamide
Drug: goserelin acetate
Drug: leuprolide acetate
Procedure: adjuvant therapy
Radiation: 3-dimensional conformal radiation therapy
Radiation: intensity-modulated radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adjuvant 3DCRT/IMRT in Combination With Androgen Suppression and Docetaxel for High Risk Prostate Cancer Patients Post-Prostatectomy: A Phase II Trial

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Freedom from progression at 3 years [ Time Frame: From registration to 3 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local-regional progression [ Time Frame: From registration to date of failure (local progression) or death or last follow-up. Analysis occurs at the same time as the primary endpoint. ] [ Designated as safety issue: No ]
  • Distant metastasis [ Time Frame: From registration to date of failure (distant metastasis) or death or last follow-up. Analysis occurs at the same time as the primary endpoint. ] [ Designated as safety issue: No ]
  • Prostate cancer specific survival [ Time Frame: From registration to date of failure (death due to prostate cancer) or death due to other causes or last follow-up. Analysis occurs at the same time as the primary endpoint. ] [ Designated as safety issue: No ]
  • Non-prostate cancer specific survival [ Time Frame: From registration to date of failure (death due to other causes) or death due to prostate cancer or last follow-up. Analysis occurs at the same time as the primary endpoint. ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: From registration to date of failure (death) or last follow-up. Analysis occurs at the same time as the primary endpoint. ] [ Designated as safety issue: No ]
  • Time to biochemical (PSA) failure [ Time Frame: From registration to date of failure (PSA ≥ 4.0 confirmed by a second higher PSA, or non-protocol hormones) or death or last follow-up. Analysis occurs at the same time as the primary endpoint. ] [ Designated as safety issue: No ]
  • Grade 3 and late adverse events [ Time Frame: From 121 days to 751 days after the end of treatment. ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: April 2008
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Androgen suppression followed by EBRT and docetaxel
Androgen suppression followed by external beam radiation therapy (EBRT) and docetaxel.
Drug: bicalutamide Drug: docetaxel Drug: flutamide Drug: goserelin acetate Drug: leuprolide acetate Procedure: adjuvant therapy Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Pathologically proven adenocarcinoma of the prostate cancer meeting 1 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 ≤ 0.2 ng/mL at the time of study registration

    • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528866

  Hide Study Locations
Locations
United States, Arizona
Arizona Oncology Services Foundation
Phoenix, Arizona, United States, 85013
United States, California
Auburn Radiation Oncology
Auburn, California, United States, 95603
Radiation Oncology Centers - Cameron Park
Cameron Park, California, United States, 95682
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, United States, 95608
Radiation Oncology Center - Roseville
Roseville, California, United States, 95661
Mercy General Hospital
Sacramento, California, United States, 95819
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States, 95815
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Solano Radiation Oncology Center
Vacaville, California, United States, 95687
United States, Colorado
Urology Center of Colorado
Denver, Colorado, United States, 80211
Poudre Valley Radiation Oncology
Fort Collins, Colorado, United States, 80528
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Illinois
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States, 62702
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Kentucky
Norton Suburban Hospital
Louisville, Kentucky, United States, 40207
United States, Louisiana
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, United States, 71315-3198
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States, 70809
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Fall River, Massachusetts, United States, 02721
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States, 56303
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
United States, Mississippi
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Cancer Institute of Cape Girardeau, LLC
Cape Girardeau, Missouri, United States, 63703
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, New Jersey
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States, 08053
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
University Medical Center at Princeton
Princeton, New Jersey, United States, 08540-3298
United States, North Carolina
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
Wayne Radiation Oncology
Goldsboro, North Carolina, United States, 27534
Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Cancer Centers of North Carolina - Raleigh
Raleigh, North Carolina, United States, 27607
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States, 44309-2090
Barberton Citizens Hospital
Barberton, Ohio, United States, 44203
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Cancer Care Center, Incorporated
Salem, Ohio, United States, 44460
Precision Radiotherapy at University Pointe
West Chester, Ohio, United States, 45069
Cancer Treatment Center
Wooster, Ohio, United States, 44691
United States, Oklahoma
Integris Oncology Services
Oklahoma City, Oklahoma, United States, 73112
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
St. Luke's Cancer Network at St. Luke's Hospital
Bethlehem, Pennsylvania, United States, 18015
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Fox Chase Cancer Center Buckingham
Furlong, Pennsylvania, United States, 18925
Fox Chase Cancer Center CCOP Research Base
Philadelphia, Pennsylvania, United States, 19140
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Crozer-Chester Medical Center
Upland, Pennsylvania, United States, 19013
United States, South Carolina
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
United States, Utah
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States, 84157
United States, Washington
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
United States, Wisconsin
Community Memorial Hospital Cancer Care Center
Menomonee Falls, Wisconsin, United States, 53051
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Canada, Quebec
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Principal Investigator: Mark Hurwitz, MD Thomas Jefferson University and Hospitals
Study Chair: Oliver Sartor, MD Dana-Farber Cancer Institute
Study Chair: Ying Xiao, PhD Bodine Center for Cancer Treatment at Thomas Jefferson University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00528866     History of Changes
Other Study ID Numbers: RTOG-0621, CDR0000563917, NCI-2009-00740
Study First Received: September 10, 2007
Last Updated: May 19, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
adenocarcinoma of the prostate
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer

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

ClinicalTrials.gov processed this record on July 22, 2014