Radiation Therapy in Treating Patients With Prostate Cancer

A Randomised Trial of High Dose Therapy in Localised Cancer of the Prostate Using Conformal Radiotherapy Techniques

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00003290

Enrollment

800

Registered

2003-04-23

Start date

1998-01-31

Completion date

2004-08-31

Last updated

2013-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer

Brief summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether standard radiation therapy is more effective than high-dose radiation therapy in treating patients with prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of standard radiation therapy with that of high-dose radiation therapy in treating patients with stage II or stage III prostate cancer.

Detailed description

OBJECTIVES: * Compare local tumor control in patients with stage II or III prostate cancer treated with neoadjuvant androgen deprivation therapy with standard vs high-dose conformal radiotherapy. * Compare the incidence of biochemical failure (prostate-specific antigen (PSA) greater than 2 ng/mL at 6 or more months after initiation of radiotherapy and PSA rising from nadir level by at least 50%), development of metastases, and survival in patients treated with these regimens. * Compare the acute and late radiation-induced side effects of these regimens in this patient population. * Compare aspects of quality of life, health economics, models of normal tissue, and tumor control in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prostate-specific antigen, T stage, and Gleason score. Patients are randomized to one of two treatment arms. All patients receive neoadjuvant androgen deprivation with luteinizing hormone-releasing hormone agonists every 4 weeks beginning 3-6 months before initiation of radiotherapy and continuing until completion of radiotherapy. * Arm I: Patients undergo standard conformal radiotherapy for 6.5 weeks. * Arm II: Patients undergo high-dose conformal radiotherapy for 7.5 weeks. Quality of life is assessed at baseline, every 6 months for 2 years, and then annually thereafter. Patients are followed every 6 months for 2 years and then annually thereafter. PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.

Interventions

BIOLOGICALgonadotrophin releasing hormone

RADIATIONradiation therapy

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Eligibility

Sex/Gender

MALE

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed prostate cancer * T1b-T3a, N0, M0 (stage II or III) * Prostate-specific antigen at least 50 ng/mL PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * WBC greater than 4,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 11 g/dL Hepatic: * Not specified Renal: * Not specified Other: * No significant past medical history that would preclude radical radiotherapy * No condition that would preclude standard radiotherapy * No hip prosthesis PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * No prior androgen deprivation therapy Radiotherapy: * No prior pelvic radiotherapy Surgery: * No prior radical prostatectomy

Countries

South Africa, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026