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Phase II Trial of Androgen Suppression for 6 Months Combined With External Beam Radiotherapy (EBRT) With Brachytherapy (BT) Boost for Intermediate Risk Prostate Cancer


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

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Trial Information

Phase II Trial of Androgen Suppression for 6 Months Combined With External Beam Radiotherapy (EBRT) With Brachytherapy (BT) Boost for Intermediate Risk Prostate Cancer


OBJECTIVES:

- Determine the feasibility of androgen-suppression therapy combined with external-beam
radiotherapy and boost brachytherapy (EBRT+BT) in patients with intermediate-risk
localized prostate cancer.

- Determine the safety of EBRT+BT in these patients.

- Determine, in a preliminary manner, the efficacy of EBRT+BT in terms of rate of local
recurrence at 5 years, time to prostate-specific antigen failure, and time to first
rectal/bladder injury, in these patients.

OUTLINE: Patients receive either leuprolide intramuscularly or goserelin subcutaneously once
every 12 weeks for a total of 24 weeks. Patients also receive either oral flutamide three
times daily or oral bicalutamide once daily for 4 weeks.

Within 4 weeks after initiation of androgen-suppression therapy, patients undergo
external-beam radiotherapy (EBRT) once daily, 5 days a week, for 5 weeks. At 2-4 weeks after
completion of EBRT, patients undergo transrectal ultrasound-guided boost brachytherapy with
implanted iodine I 125 or palladium Pd 103 seeds.

Patients are followed every 3 months for 2 years and then every 6 months for 4 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate

- Must have one of the following prognostic factors:

- Stage T1-2, N0; prostate-specific antigen (PSA) ≤ 10 ng/mL; and Gleason
score > 6

- Stage T1-2, N0; PSA > 10 ng/mL and < 20 ng/mL; and Gleason score ≤ 6

- Stage T3a, N0; PSA ≤ 10 ng/mL; and Gleason score ≤ 6

- Prostate volume < 60 cc by transrectal ultrasound

- No distant or nodal metastases

- No metastatic disease by bone scan, CT scan, or MRI

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic:

- Bilirubin ≤ 1.5 times upper limit of normal

Renal:

- Not specified

Other:

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior immunotherapy for prostate cancer

Chemotherapy:

- No prior chemotherapy for prostate cancer

Endocrine therapy:

- Prior androgen-suppression therapy for up to 4 weeks duration allowed if initiated
within 4 weeks of study radiotherapy

- No other prior hormonal therapy

Radiotherapy:

- No prior radiotherapy for prostate cancer

Surgery:

- No prior surgery for prostate cancer

- No prior transurethral resection of the prostate

Other:

- No prior alternative therapy (e.g., PC-SPES) for prostate cancer

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity

Outcome Time Frame:

q 3 mon for 2 yrs post tx initiation

Safety Issue:

Yes

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:

CDR0000068228

NCT ID:

NCT00006359

Start Date:

September 2000

Completion Date:

March 2012

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • Prostatic Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Zimmer Cancer Center at New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
Brigham and Women's HospitalBoston, Massachusetts  02115
Cancer Institute of New Jersey at the Cooper University Hospital - VoorheesCamden, New Jersey  08103
Beebe Medical CenterLewes, Delaware  19958
St. Francis HospitalWilmington, Delaware  19805
Union Hospital Cancer Center at Union HospitalElkton MD, Maryland  21921
Community General Hospital of Greater SyracuseSyracuse, New York  13215
Danville Regional Medical CenterDanville, Virginia  24541
Hudner Oncology Center at Saint Anne's HospitalFall River, Massachusetts  02721
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Washoe Cancer Services at Washoe Medical Center - RenoReno, Nevada  89502
Arch Medical Services, Incoroporated at Center for Cancer Care ResearchSaint Louis, Missouri  63141