Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00258466
First received: November 23, 2005
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. It is not yet known which type of radiation therapy is more effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying different types of radiation therapy to compare how well they work in treating patients with stage I, stage II, or stage III prostate cancer.


Condition Intervention Phase
Prostate Cancer
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Trial of Neutron + Photon Radiation Versus Photon + Hypofractionated Intensity Modulated Radiation Therapy in Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Occurrence of chronic grade 2 or higher toxicity as measured by RTOG/EORTC late morbidity scoring scheme at 1, 4, 8, and 12 months after treatment, then every 6 months for 5 years, then annually [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disease free survival at 1, 4, 8, and 12 months after treatment, then every 6 months for 5 years, then annually [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Compare the efficacy of neutron and photon radiotherapy vs hypofractionated intensity modulated radiation, in terms of a lower frequency of chronic complication rate (chronic toxicity and disease-free survival), in patients with favorable to intermediate prognosis, stage I-III adenocarcinoma of the prostate.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage of disease (T1 vs T2 vs T3). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo neutron radiotherapy over 15-45 minutes 5 days a week for 2 weeks followed by photon radiotherapy over 15-45 minutes 5 days a week for 5 weeks.
  • Arm II: Patients undergo photon radiotherapy over 15-45 minutes 5 days a week for 5 weeks followed by hypofractionated photon irradiation over 15-45 minutes 5 days a week for 2 weeks.

After completion of study treatment, patients are followed periodically for 5 years and then yearly thereafter.

PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Stage I-III disease (T1-T3, N0, M0)
    • No clinical or radiographic evidence of metastasis

      • If prostate-specific antigen (PSA) ≥ 10.0 ng/mL and Gleason score is 7, a radioisotope bone scan must show no evidence of metastasis
      • No evidence of lymphatic or visceral metastases of the abdomen or pelvis on CT scan or MRI
  • PSA ≤ 20 ng/mL
  • Gleason score ≤ 7 (if stage T3 , score must be < 7)

PATIENT CHARACTERISTICS:

Performance status

  • Not specified

Life expectancy

  • More than 10 years

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Endocrine therapy

  • Prior hormonal therapy allowed provided it was initiated no more than 2 months ago, and may include the following:

    • Luteinizing hormone-releasing hormone agonists (e.g., goserelin, leuprolide)
    • Anti-androgens (e.g., flutamide, bicalutamide)

Radiotherapy

  • No prior pelvic irradiation

Surgery

  • No prior radical prostatectomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258466

Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Study Chair: Jeffrey D. Forman, MD, FACR Weisberg Cancer Treatment Center
  More Information

Additional Information:
No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00258466     History of Changes
Other Study ID Numbers: CDR0000447161, P30CA022453, WSU-D-2879, WSU-HIC-047405MP4F
Study First Received: November 23, 2005
Last Updated: April 5, 2013
Health Authority: United States: Federal Government

Keywords provided by Barbara Ann Karmanos Cancer Institute:
adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 23, 2014