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Phase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate


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

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Trial Information

Phase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate


OBJECTIVES:

Primary

- Determine the rate of late grade 3 or greater genitourinary and gastrointestinal
toxicity after treatment with external beam radiotherapy and high-dose rate
brachytherapy in patients with stage II or III adenocarcinoma of the prostate.

Secondary

- Determine acute grade 3 or greater genitourinary and gastrointestinal toxicity in
patients treated with this regimen.

- Determine freedom from biochemical failure in patients treated with this regimen.

- Determine overall survival of patients treated with this regimen.

- Determine disease-specific survival of patients treated with this regimen.

- Determine clinical relapse (local and/or distant) in patients treated with this
regimen.

- Develop a quality assurance process for high-dose rate prostate brachytherapy.

OUTLINE: This is a multicenter study. Patients are stratified according to prostate-specific
antigen (≤ 10 ng/mL vs 11-20 ng/mL), T stage (T1c-T2c vs T3a-T3b), combined Gleason score
(2-6 vs 7 vs 8-10), prior hormonal therapy (no vs yes), and timing of high-dose rate
brachytherapy (before external beam radiotherapy vs after external beam radiotherapy).

Patients undergo external beam radiotherapy over approximately 15 minutes once daily 5 days
a week for 5 weeks. Patients also receive two fractions (within a 24-hour period) of
high-dose rate brachytherapy (delivered through an implant inserted into the prostate) over
approximately 5-30 minutes either before or after external beam radiotherapy. Treatment
continues in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3, 7, 9, and 12 months, every 6 months for 5 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate

- Clinical stage T1c-T3b

- No clinically or pathologically involved lymph nodes (N0 by pelvic CT scan or
MRI)

- No distant metastases (M0 by negative bone scan)

- Meets one of the following combination criteria:

- Clinical stage T1c-T2c, Gleason score 2-6, and prostate-specific antigen (PSA) >
10 but ≤ 20 ng/mL

- Clinical stage T3a-T3b, Gleason score 2-6, and PSA ≤ 20 ng/mL

- Clinical stage T1c-T3b, Gleason score 7-10, and PSA ≤ 20 ng/mL

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Other

- Fertile patients must use effective contraception

- No hip prosthesis

- No major medical or psychiatric illness that would preclude study participation

- No prior invasive malignancy except nonmelanomatous skin cancer (e.g., carcinoma in
situ of the oral cavity or bladder) or any other malignancy with a disease-free
status ≥ 3 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy for prostate cancer

Endocrine therapy

- Prior induction hormonal therapy allowed provided therapy was initiated within 90
days before study enrollment

Radiotherapy

- No prior pelvic or prostate radiotherapy

- No concurrent intensity-modulated radiotherapy

Surgery

- No prior radical surgery for prostate cancer

- No prior transurethral resection of the prostate

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Late severe genitourinary (GU) and gastrointestinal (GI) toxicity as measured by CTCAE v3.0 more than 9 months after starting treatment

Safety Issue:

Yes

Principal Investigator

I-Chow J. Hsu, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Federal Government

Study ID:

CDR0000382120

NCT ID:

NCT00091390

Start Date:

July 2004

Completion Date:

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
Newark Beth Israel Medical CenterNewark, New Jersey  07112
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Maine Center for Cancer Medicine and Blood Disorders - ScarboroughScarborough, Maine  04074
Waukesha Memorial Hospital Regional Cancer CenterWaukesha, Wisconsin  53188
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
OSF St. Francis Medical CenterPeoria, Illinois  61637
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial HospitalInglewood, California  90301
Radiological Associates of Sacramento Medical Group, IncorporatedSacramento, California  95815
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main CenterBoca Raton, Florida  33486