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Search / Trial NCT00946543

Intensity-Modulated Radiation Therapy in Treating Patients With Prostate Cancer

Launched by ROYAL MARSDEN NHS FOUNDATION TRUST · Jul 24, 2009

Trial Information

Current as of July 24, 2025

Unknown status

Keywords

Stage Iib Prostate Cancer Stage Iia Prostate Cancer Stage Iii Prostate Cancer Stage Iv Prostate Cancer

ClinConnect Summary

OBJECTIVES:

* 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 ...

Gender

MALE

Eligibility criteria

  • DISEASE CHARACTERISTICS:
  • * 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)

About Royal Marsden Nhs Foundation Trust

The Royal Marsden NHS Foundation Trust is a leading cancer treatment and research institution in the UK, renowned for its commitment to advancing oncology through innovative clinical trials and cutting-edge therapies. With a multidisciplinary team of experts, the Trust integrates patient care with groundbreaking research, fostering a collaborative environment to improve outcomes for cancer patients. As a pioneer in the field, the Royal Marsden actively contributes to the development of new treatment protocols and plays a critical role in translating scientific discoveries into clinical practice, ensuring that patients have access to the latest advancements in cancer care.

Locations

Sutton, England, United Kingdom

Sutton, England, United Kingdom

London, England, United Kingdom

Patients applied

0 patients applied

Trial Officials

David P. Dearnaley, MD, FRCP, FRCR

Principal Investigator

Royal Marsden NHS Foundation Trust

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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