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| ID | Type | Description | Link |
|---|---|---|---|
| RMNHS-1766 | |||
| EU-20869 |
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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.
PURPOSE: This phase I trial is studying the best dose of intensity-modulated radiation therapy in treating patients with prostate cancer.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypofractionated radiation therapy | Radiation | |||
| intensity-modulated radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Late RTOG radiotherapy toxicity as assessed at 6, 12, 18, and 24 months and then annually thereafter |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | ||
| Local control | ||
| PSA control |
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DISEASE CHARACTERISTICS:
Diagnosis of prostate cancer meeting 1 of the following criteria:
Candidate for radical radiotherapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| David P. Dearnaley, MD, FRCP, FRCR | Royal Marsden NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Cancer Research - Chelsea | Recruiting | London | England | SW3 6JB | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38997466 | Derived | 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. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Acute side effects as assessed weekly by the RTOG scoring system |
| Quality of life |
| Patterns of recurrence |
| Institute of Cancer Research - Sutton | Recruiting | Sutton | England | SM2 5NG | United Kingdom |
|
| Royal Marsden - Surrey | Recruiting | Sutton | England | SM2 5PT | United Kingdom |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |