Know Cancer

or
forgot password

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

Thank you

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 CarolinaSpartanburg, South Carolina  29303
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
CCOP - OchsnerNew Orleans, Louisiana  70121
Rapid City Regional HospitalRapid City, South Dakota  57709
Newark Beth Israel Medical CenterNewark, New Jersey  07112
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Tulane Cancer Center Office of Clinical ResearchAlexandria, Louisiana  71315-3198
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Mary Bird Perkins Cancer Center - Baton RougeBaton Rouge, Louisiana  70809
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Forsyth Regional Cancer Center at Forsyth Medical CenterWinston-Salem, North Carolina  27103
Delaware County Regional Cancer Center at Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Poudre Valley Radiation OncologyFort Collins, Colorado  80528
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
Cancer Treatment CenterWooster, Ohio  44691
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Barberton Citizens HospitalBarberton, Ohio  44203
St. Luke's Cancer Network at St. Luke's HospitalBethlehem, Pennsylvania  18015
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Fox Chase Cancer Center CCOP Research BasePhiladelphia, Pennsylvania  19140
Arizona Oncology Services FoundationPhoenix, Arizona  85013
Radiological Associates of Sacramento Medical Group, IncorporatedSacramento, California  95815
Pardee Memorial HospitalHendersonville, North Carolina  28791
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Community Memorial Hospital Cancer Care CenterMenomonee Falls, Wisconsin  53051
Cancer Institute at St. John's HospitalSpringfield, Illinois  62701
Crozer-Chester Medical CenterUpland, Pennsylvania  19013
Solano Radiation Oncology CenterVacaville, California  95687
Mercy General HospitalSacramento, California  95819
Cancer Care Center, IncorporatedSalem, Ohio  44460
Cancer Institute of Cape Girardeau, LLCCape Girardeau, Missouri  63703
Cancer Centers of North Carolina - RaleighRaleigh, North Carolina  27607
Precision Radiotherapy at University PointeWest Chester, Ohio  45069
Hudner Oncology Center at Saint Anne's Hospital - Fall RiverFall River, Massachusetts  02721
Integris Oncology ServicesOklahoma City, Oklahoma  73112
University Medical Center at PrincetonPrinceton, New Jersey  08540
Auburn Radiation OncologyAuburn, California  95603
Radiation Oncology Centers - Cameron ParkCameron Park, California  95682
Radiation Oncology Center - RosevilleRoseville, California  95661
Mercy Cancer Center at Mercy San Juan Medical CenterCarmichael, California  95608
Nevada Cancer InstituteLas Vegas, Nevada  89135
Norton Suburban HospitalLouisville, Kentucky  40207
Urology Center of ColoradoDenver, Colorado  80211
Fox Chase Cancer Center BuckinghamFurlong, Pennsylvania  18925