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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

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Trial Conditions
  • Prostate Cancer
What is the purpose of this trial?

RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving hypofractionated radiation therapy (higher doses over a shorter period of time), may kill more tumor cells and have fewer side effects. It is not yet known which radiation therapy regimen is more effective in treating prostate cancer. PURPOSE: This randomized phase III trial is studying several different radiation therapy regimens to compare how well they work in treating patients with stage II prostate cancer.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Male

Eligibility

DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- 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

PRIOR CONCURRENT THERAPY:

- 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

Gender: Male
Steward Physician(s)
  • W. Robert Lee, MD
Facilities
  • Saint Anne's Hospital - Active, not recruiting
Trial Interventions
Radiation
  • 3-dimensional conformal radiation therapy (3D-CRT)
  • hypofractionated radiation therapy
  • Intensity-modulated radiation therapy (IMRT)
Physician Researcher

Investigator Name:

  • W. Robert Lee, MD

Other Information

Sponsor: Radiation Therapy Oncology Group
Phase: Phase 3
Trial ID: NCT00331773
Volunteers:  Not Accepting Healthy Volunteers

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