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A Phase III Randomized Study Of High Dose 3D-CRT/IMRT Versus Standard Dose 3D-CRT/IMRT In Patients Treated For Localized Prostate Cancer

Phase 3
Open (Enrolling)
Prostate Cancer

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Trial Information

A Phase III Randomized Study Of High Dose 3D-CRT/IMRT Versus Standard Dose 3D-CRT/IMRT In Patients Treated For Localized Prostate Cancer


- Compare the overall survival of patients with stage II adenocarcinoma of the prostate
treated with high- vs standard-dose three-dimensional conformal or intensity-modulated

- Compare the freedom from prostate-specific antigen failure, disease-specific survival,
local progression, and distant metastases in patients treated with these regimens.

- Compare the probability of tumor control and normal tissue complications in patients
treated with these regimens.

- Compare the incidence of grade 2 or greater genitourinary and gastrointestinal acute
and late toxicity in patients treated with these regimens.

- Compare the quality of life, including sexual function, of patients treated with these

- Correlate histopathologic or tumor-specific cytogenetic or chromosomal markers with
cancer control outcomes in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
Gleason score and prostate-specific antigen (PSA) level (Gleason score 2-6, PSA ≥10 mg/mL
but < 20 ng/mL vs Gleason score 7, PSA < 15 ng/mL) and radiation modality (three-dimensional
conformal radiotherapy [3D-CRT] vs intensity-modulated radiotherapy [IMRT]). Patients are
randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo standard-dose 3D-CRT or IMRT once daily, 5 days a week, for 7.8
weeks (39 treatment days).

- Arm II: Patients undergo high-dose 3D-CRT or IMRT once daily, 5 days a week, for 8.8
weeks (44 treatment days).

Quality of life (QOL) is assessed initially at baseline. After completion of radiotherapy,
QOL is assessed every 3 months for 1 year and then every 6 months for 4 years.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 1,520 patients (760 per treatment arm) will be accrued for
this study within 5 years.

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the prostate

- Clinical stage T1b-T2b

- Meets one of the following criteria:

- Gleason score 2-6 AND prostate-specific antigen (PSA) ≥ 10 ng/mL but < 20 ng/mL

- Gleason score 7 AND PSA < 15 ng/mL

- No regional lymph node involvement

- No distant metastases



- Any age

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified


- Not specified


- Not specified


- Not specified


- No other invasive malignancy within the past 5 years except localized basal cell or
squamous cell skin cancer

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

- Fertile patients must use effective contraception


Biologic therapy:

- Not specified


- No prior cytotoxic chemotherapy

- No concurrent cytotoxic chemotherapy

Endocrine therapy:

- At least 3 months since prior finasteride

- No other prior hormonal therapy, including:

- Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide)

- Antiandrogens (e.g., flutamide or bicalutamide)

- Estrogens (e.g., diethylstilbestrol)

- No concurrent (neoadjuvant or adjuvant) hormonal therapy


- No prior pelvic irradiation or prostatic brachytherapy


- No prior radical surgery (prostatectomy) or cryosurgery for prostate cancer

- No prior surgical castration (bilateral orchiectomy)


- At least 3 months since prior finasteride or PC SPES

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Safety Issue:


Principal Investigator

Jeff M. Michalski, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 2002

Completion Date:

Related Keywords:

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



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