Intensity-Modulated Radiation Therapy in Treating Patients With Prostate Cancer
NCT ID: NCT00946543
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
198 participants
INTERVENTIONAL
2000-03-31
Brief Summary
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PURPOSE: This phase I trial is studying the best dose of intensity-modulated radiation therapy in treating patients with prostate cancer.
Detailed Description
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* To test the feasibility of delivering hypofractionated intensity-modulated radiotherapy to the prostate and pelvic nodes of patients with prostate cancer.
* To determine the optimal dose level of this treatment regimen to be used in future studies.
OUTLINE: Patients are stratified according to small bowel total volume (low small bowel volume \< 450 cc vs high small bowel volume ≥ 450 cc).
Patients undergo hypofractionated intensity-modulated radiotherapy to the prostate and pelvis for 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 5 years and then annually thereafter.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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hypofractionated radiation therapy
intensity-modulated radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of prostate cancer meeting 1 of the following criteria:
* Stage T3b/T4 disease or radiological or pathological pelvic nodal metastases
* Localized disease (stage pT2-T4) with \> 30% estimated risk of pelvic nodal metastases
* High-risk (Gleason score ≥ 8 or ≥ 2 risk factors) or very high-risk disease according to the National Collaborative Cancer Network (NCCN)
* Has undergone prostatectomy AND has stage T2-T3a, N0 disease with extensive high-risk disease (Gleason score ≥ 8) or seminal vesicle or lymph node involvement
* Candidate for radical radiotherapy
PATIENT CHARACTERISTICS:
* No inflammatory bowel disease or other small bowel disease
PRIOR CONCURRENT THERAPY:
* No prior pelvic radiotherapy or surgery (excluding prostatectomy)
MALE
No
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Principal Investigators
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David P. Dearnaley, MD, FRCP, FRCR
Role: PRINCIPAL_INVESTIGATOR
Royal Marsden NHS Foundation Trust
Locations
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Institute of Cancer Research - Chelsea
London, England, United Kingdom
Institute of Cancer Research - Sutton
Sutton, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Countries
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Facility Contacts
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Contact Person
Role: primary
Contact Person
Role: primary
David P. Dearnaley, MD, FRCP, FRCR
Role: primary
References
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Fernandez-Mateos J, Cresswell GD, Trahearn N, Webb K, Sakr C, Lampis A, Stuttle C, Corbishley CM, Stavrinides V, Zapata L, Spiteri I, Heide T, Gallagher L, James C, Ramazzotti D, Gao A, Kote-Jarai Z, Acar A, Truelove L, Proszek P, Murray J, Reid A, Wilkins A, Hubank M, Eeles R, Dearnaley D, Sottoriva A. Tumor evolution metrics predict recurrence beyond 10 years in locally advanced prostate cancer. Nat Cancer. 2024 Sep;5(9):1334-1351. doi: 10.1038/s43018-024-00787-0. Epub 2024 Jul 12.
Other Identifiers
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RMNHS-1766
Identifier Type: -
Identifier Source: secondary_id
EU-20869
Identifier Type: -
Identifier Source: secondary_id
CDR0000601695
Identifier Type: -
Identifier Source: org_study_id