Radiation Therapy in Treating Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Phase I Study of 3-Dimensional Conformal Radiotherapy in Patients With Locally Advanced (Stage T2c and T3) Adenocarcinoma of the Prostate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002480
• Other study ID #: 91-022
• Secondary ID: CDR0000077099NCI
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: June 24, 2013
• Start date: February 1991
• Est. completion date: August 2005

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy may be an effective treatment for prostate cancer.

PURPOSE: Phase I trial to study the effectiveness of radiation therapy in treating patients who have stage II or stage III prostate cancer.

Description:

OBJECTIVES: I. Determine the maximum tolerated dose of radiotherapy using 3-dimensional (3D) conformal techniques in patients with stage II or III adenocarcinoma of the prostate. II. Determine the morbidity of high-dose 3D conformal therapy in these patients.

OUTLINE: This is a dose escalation study. Patients undergo 3-dimensional conformal radiotherapy 4-5 days a week for at least 8 weeks. Cohorts of 20-40 patients receive escalating doses of radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 10% of patients experience dose-limiting toxicity. Patients are followed at 3 months, every 6 months for 5 years, and then annually thereafter.

PROJECTED ACCRUAL: A minimum of 40 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS: Locally advanced (T2c-T3) adenocarcinoma of the prostate including: Bulky tumors confined to prostate (stage II) Tumors extending beyond capsule (stage III) PSA no greater than 20 ng/mL No regional lymph node involvement (by CT scan or surgical sampling) No distant metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC greater than 4,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 11 g/dL Hepatic: Not specified Renal: Not specified Other: No major medical or psychiatric illness that would preclude study No metallic pelvic prosthesis

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: Prior hormonal therapy allowed Radiotherapy: No prior radiotherapy (including pelvic irradiation) Surgery: No prior radical surgery for carcinoma of the prostate

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

Leibel SA, Heimann R, Kutcher GJ, Zelefsky MJ, Burman CM, Melian E, Orazem JP, Mohan R, LoSasso TJ, Lo YC, et al. Three-dimensional conformal radiation therapy in locally advanced carcinoma of the prostate: preliminary results of a phase I dose-escalation — View Citation

Leibel SA, Zelefsky MJ, Kutcher GJ, Burman CM, Kelson S, Fuks Z. Three-dimensional conformal radiation therapy in localized carcinoma of the prostate: interim report of a phase 1 dose-escalation study. J Urol. 1994 Nov;152(5 Pt 2):1792-8. — View Citation

Leibel SA, Zelefsky MJ, Kutcher GJ, Burman CM, Mohan R, Mageras GS, Ling CC, Fuks Z. The biological basis and clinical application of three-dimensional conformal external beam radiation therapy in carcinoma of the prostate. Semin Oncol. 1994 Oct;21(5):580 — View Citation

Zelefsky MJ, Leibel SA, Burman CM, Kutcher GJ, Harrison A, Happersett L, Fuks Z. Neoadjuvant hormonal therapy improves the therapeutic ratio in patients with bulky prostatic cancer treated with three-dimensional conformal radiation therapy. Int J Radiat O — View Citation

Zelefsky MJ, Leibel SA, Kutcher GJ, Kelson S, Ling CC, Fuks Z. The feasibility of dose escalation with three-dimensional conformal radiotherapy in patients with prostatic carcinoma. Cancer J Sci Am. 1995 Jul-Aug;1(2):142-50. — View Citation