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A Phase III Study Comparing Combined External Beam Radiation and Transperineal Interstitial Permanent Brachytherapy With Brachytherapy Alone for Selected Patients With Intermediate Risk Prostatic Carc

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

RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Interstitial brachytherapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining interstitial brachytherapy with external-beam radiation therapy may kill more tumor cells. It is not yet known whether interstitial brachytherapy is more effective with or without external-beam radiation therapy in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of interstitial brachytherapy with or without external-beam radiation therapy in treating patients who have 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

- T1c-T2b, N0, M0

- Intermediate-risk disease, as defined by 1 of the following:

- Gleason score < 7 AND prostate-specific antigen (PSA) 10-20 ng/mL

- Gleason score 7 AND PSA < 10 ng/mL

- No evidence of distant metastases

- Prostate volume ≤ 60 cc by transrectal ultrasonography

- American Urological Association voiding symptom score no greater than 15 (alpha
blockers allowed)

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Other

- Patients must use effective contraception

- No other malignancy within the past 5 years except basal cell or squamous cell skin
cancer or carcinoma in situ at any other site

- No major medical or psychiatric illness that would preclude study therapy

- No hip prosthesis

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy

Endocrine therapy

- Prior neoadjuvant hormonal therapy allowed provided the following are true:

- Therapy was initiated within 2-6 months of study enrollment

- Therapy was no more than 6 months in duration

- Use of 5-alpha reductase inhibitors (e.g., finasteride) is discontinued before
registration

- No concurrent hormonal therapy

Radiotherapy

- No prior pelvic radiotherapy

Surgery

- No prior radical surgery for prostate cancer

- No prior transurethral resection of the prostate

- No prior cryosurgery

Other

- No prior transurethral needle ablation of the prostate

- No prior transurethral microwave thermotherapy of the prostate

Gender: Male
Steward Physician(s)
  • Bradley R. Prestidge, MD
Trial Interventions
Radiation
  • iodine I 125
  • palladium Pd 103
  • radiation therapy
Physician Researcher

Investigator Name:

  • Bradley R. Prestidge, MD

Other Information

Sponsor: Radiation Therapy Oncology Group
Phase: Phase 3
Trial ID: NCT00063882
Volunteers:  Not Accepting Healthy Volunteers

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