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Adjuvant 3DCRT/IMRT in Combination With Androgen Suppression and Docetaxel for High Risk Prostate Cancer Patients Post-Prostatectomy: A Phase II Trial


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Adjuvant 3DCRT/IMRT in Combination With Androgen Suppression and Docetaxel for High Risk Prostate Cancer Patients Post-Prostatectomy: A Phase II Trial


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 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.

Inclusion 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 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

- 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)

- ALT and 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 dutaseride, 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Freedom from progression at 2 years

Safety Issue:

No

Principal Investigator

Mark Hurwitz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber/Brigham and Women's Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000563917

NCT ID:

NCT00528866

Start Date:

April 2008

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location

CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
Minnesota Oncology Hematology, PA - Maplewood Maplewood, Minnesota  55109
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
CCOP - Ochsner New Orleans, Louisiana  70121
Rapid City Regional Hospital Rapid City, South Dakota  57709
Newark Beth Israel Medical Center Newark, New Jersey  07112
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
CCOP - Virginia Mason Research Center Seattle, Washington  98101
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
Mission Hospitals - Memorial Campus Asheville, North Carolina  28801
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
Greenebaum Cancer Center at University of Maryland Medical Center Baltimore, Maryland  21201
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
Tulane Cancer Center Office of Clinical Research Alexandria, Louisiana  71315-3198
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Marlton, New Jersey  08053
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497
Mary Bird Perkins Cancer Center - Baton Rouge Baton Rouge, Louisiana  70809
CentraCare Clinic - River Campus St. Cloud, Minnesota  56303
Wayne Radiation Oncology Goldsboro, North Carolina  27534
Forsyth Regional Cancer Center at Forsyth Medical Center Winston-Salem, North Carolina  27103
Delaware County Regional Cancer Center at Delaware County Memorial Hospital Drexel Hill, Pennsylvania  19026
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Poudre Valley Radiation Oncology Fort Collins, Colorado  80528
Regional Cancer Center at Singing River Hospital Pascagoula, Mississippi  39581
Cancer Treatment Center Wooster, Ohio  44691
Summa Center for Cancer Care at Akron City Hospital Akron, Ohio  44309-2090
Barberton Citizens Hospital Barberton, Ohio  44203
St. Luke's Cancer Network at St. Luke's Hospital Bethlehem, Pennsylvania  18015
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray, Utah  84157
Fox Chase Cancer Center CCOP Research Base Philadelphia, Pennsylvania  19140
Arizona Oncology Services Foundation Phoenix, Arizona  85013
Radiological Associates of Sacramento Medical Group, Incorporated Sacramento, California  95815
Pardee Memorial Hospital Hendersonville, North Carolina  28791
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Community Memorial Hospital Cancer Care Center Menomonee Falls, Wisconsin  53051
Cancer Institute at St. John's Hospital Springfield, Illinois  62701
Crozer-Chester Medical Center Upland, Pennsylvania  19013
Solano Radiation Oncology Center Vacaville, California  95687
Mercy General Hospital Sacramento, California  95819
Cancer Care Center, Incorporated Salem, Ohio  44460
Cancer Institute of Cape Girardeau, LLC Cape Girardeau, Missouri  63703
Cancer Centers of North Carolina - Raleigh Raleigh, North Carolina  27607
Precision Radiotherapy at University Pointe West Chester, Ohio  45069
Hudner Oncology Center at Saint Anne's Hospital - Fall River Fall River, Massachusetts  02721
Integris Oncology Services Oklahoma City, Oklahoma  73112
University Medical Center at Princeton Princeton, New Jersey  08540
Auburn Radiation Oncology Auburn, California  95603
Radiation Oncology Centers - Cameron Park Cameron Park, California  95682
Radiation Oncology Center - Roseville Roseville, California  95661
Mercy Cancer Center at Mercy San Juan Medical Center Carmichael, California  95608
Nevada Cancer Institute Las Vegas, Nevada  89135
Norton Suburban Hospital Louisville, Kentucky  40207
Urology Center of Colorado Denver, Colorado  80211
Fox Chase Cancer Center Buckingham Furlong, Pennsylvania  18925