Status:
UNKNOWN
Intensity-Modulated Radiation Therapy in Treating Patients With Localized Prostate Cancer
Lead Sponsor:
Institute of Cancer Research, United Kingdom
Conditions:
Prostate Cancer
Eligibility:
MALE
18-120 years
Phase:
NA
Brief Summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which schedu...
Detailed Description
OBJECTIVES: * Determine the safety and efficacy of conventional vs hypofractionated high-dose intensity-modulated radiotherapy in patients with localized prostate cancer. * Determine the side effects...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate, meeting the following criteria:
- Clinical stage T1b-T3a, N0, M0
- Locally confined disease
- Previously untreated disease
- Prostate-specific antigen (PSA) ≤ 30 ng/mL
- Estimated risk of seminal vesicle involvement \< 30%
- Estimated risk of seminal vesicle involvement is defined as PSA + (\[Gleason score - 6\] x 10) (i.e., if Gleason score ≤ 6, then PSA must be ≤ 30 ng/mL; if Gleason score = 7, then PSA must be \< 20 ng/mL; if Gleason score = 8, then PSA must be \< 10 ng/mL; if Gleason score = 9 or 10 patient is ineligible)
- PATIENT CHARACTERISTICS:
- WHO performance status 0 or 1
- Life expectancy \> 10 years (5 years for patients with poorly differentiated cancers)
- WBC \> 4,000/mm\^3
- Hemoglobin \> 11g/dL
- Platelet count \> 100,000/mm\^3
- No other active malignancy within the past 5 years except basal cell carcinoma
- No hip prosthesis or fixation that would interfere with standard radiation beam configuration
- No comorbid conditions likely to impact on the advisability of radical radiotherapy (e.g., previous inflammatory bowel disease, previous colorectal surgery, significant bladder instability, or urinary incontinence)
- PRIOR CONCURRENT THERAPY:
- No prior pelvic radiotherapy
- No prior radical prostatectomy
- No prior androgen-deprivation therapy
- No concurrent full anticoagulation therapy with warfarin or heparin
Exclusion
Key Trial Info
Start Date :
October 18 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2021
Estimated Enrollment :
3216 Patients enrolled
Trial Details
Trial ID
NCT00392535
Start Date
October 18 2002
End Date
June 17 2021
Last Update
February 27 2019
Active Locations (26)
Enter a location and click search to find clinical trials sorted by distance.
1
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom, RG24 9NA
2
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom, BN2 5BF
3
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
4
West Suffolk Hospital
Bury St Edmunds, England, United Kingdom, IP33 2QZ