Know Cancer

forgot password

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

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

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



- 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.


- 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

- 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


- Histologically confirmed adenocarcinoma of the prostate

- Clinical stage T1c-T3b

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

- 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



- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified


- Not specified


- Not specified


- Not specified


- 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


Biologic therapy

- Not specified


- No prior chemotherapy for prostate cancer

Endocrine therapy

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


- No prior pelvic or prostate radiotherapy

- No concurrent intensity-modulated radiotherapy


- No prior radical surgery for prostate cancer

- No prior transurethral resection of the prostate

Type of Study:


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:


Principal Investigator

I-Chow J. Hsu, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco


United States: Federal Government

Study ID:




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



Roswell Park Cancer Institute Buffalo, New York  14263
Providence Saint Joseph Medical Center - Burbank Burbank, California  91505
Newark Beth Israel Medical Center Newark, New Jersey  07112
University of Colorado Cancer Center at University of Colorado Health Sciences Center Denver, Colorado  80010
Fletcher Allen Health Care - University Health Center Campus Burlington, Vermont  05401
Maine Center for Cancer Medicine and Blood Disorders - Scarborough Scarborough, Maine  04074
Waukesha Memorial Hospital Regional Cancer Center Waukesha, Wisconsin  53188
William Beaumont Hospital - Royal Oak Campus Royal Oak, Michigan  48073
OSF St. Francis Medical Center Peoria, Illinois  61637
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital Inglewood, California  90301
Radiological Associates of Sacramento Medical Group, Incorporated Sacramento, California  95815
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center Boca Raton, Florida  33486