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A Phase III Randomized Study of Hypofractionated 3D-CRT/MRT Versus Conventionally Fractionated 3D-CRT/MRT in Patients With Favorable-Risk Prostate Cancer

Phase 3
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

A Phase III Randomized Study of Hypofractionated 3D-CRT/MRT Versus Conventionally Fractionated 3D-CRT/MRT in Patients With Favorable-Risk Prostate Cancer



- Compare the disease-free survival (DFS) of patients with favorable-risk stage II
prostate cancer treated with hypofractionated vs conventionally fractionated
three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy


- Compare time to local progression, freedom from biochemical recurrence, and
disease-specific and overall survival of patients treated with these regimens.

- Determine the incidence of gastrointestinal and genitourinary toxic effects in patients
treated with these regimens.

- Compare the degree, duration, and significant differences in disease-specific
health-related quality of life (HRQOL) decrements, using the Expanded Prostate Cancer
Index Composite (EPIC), in patients treated with these regimens.

- Determine whether anxiety and/or depression, as measured by the Hopkins Symptom
Checklist-25 (HSCL-25), are decreased with therapy that improves DFS of these patients

- Determine whether the incremental gain in DFS outweighs decrements in the generic
domains of HRQOL (i.e., mobility, self care, usual activities, pain/discomfort, and
anxiety/depression) in patients treated with these regimens.

- Conduct a cost-utility analysis of hypofractionated 3D-CRT or IMRT as a prostate cancer
therapy if this regimen is shown to be as effective as conventionally fractionated
3D-CRT or IMRT in improving DFS.

OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified
according to Gleason score (2-4 vs 5-6), prostate-specific antigen (PSA) level (< 4 ng/mL vs
4-9 ng/mL), and planned radiotherapy 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 conventionally fractionated 3D-CRT or IMRT once daily 5 days a
week for 8.2 weeks (total of 41 treatments).

- Arm II: Patients undergo hypofractionated 3D-CRT or IMRT once daily 5 days a week for
5.6 weeks (total of 28 treatments).

Quality of life, anxiety, and depression are assessed at baseline and then at 6 months and
1, 2, and 5 years after the start of radiotherapy.

After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,067 patients will be accrued to this study.

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the prostate within the past 6 months

- Clinical stage T1-2c

- Combined Gleason score 2-6

- Prostate-specific antigen (PSA) < 10 ng/mL within the past 6 months

- No PSA measurement for ≥ 10 days after prostate biopsy

- No PSA measurement for ≥ 30 days after discontinuation of finasteride (90 days
after discontinuation of dutasteride)

- No regional lymph node involvement

- No distant metastases


- Zubrod performance status 0-1

- No unstable angina and/or congestive heart failure requiring hospitalization within
the past 6 months

- No transmural myocardial infarction within the past 6 months

- No acute bacterial or fungal infection requiring IV antibiotics

- No chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study treatment

- No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

- No known AIDS

- No prior or concurrent lymphomatous/hematogenous malignancy or other invasive
malignancy except nonmelanomatous skin cancer or any other cancer for which the
patient has been continually disease-free for ≥ 5 years (e.g., carcinoma in situ of
the bladder or oral cavity)

- No other severe, active comorbidity


- See Disease Characteristics

- No prior radical prostatectomy or cryosurgery for prostate cancer

- No prior hormonal therapy, including any of the following:

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

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

- Estrogens (e.g., diethylstilbestrol [DES])

- Surgical castration (bilateral orchiectomy)

- No prior pelvic radiotherapy or prostate brachytherapy

- No prior or concurrent cytotoxic chemotherapy for prostate cancer

- At least 30 days since prior finasteride

- At least 90 days since prior dutasteride

- No concurrent neoadjuvant or adjuvant hormonal therapy

- Concurrent warfarin or other blood-thinning agents allowed

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival at 5 years as measured by Kaplan-Meier

Safety Issue:


Principal Investigator

W. Robert Lee, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute


United States: Federal Government

Study ID:




Start Date:

April 2006

Completion Date:

Related Keywords:

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



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