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Status unknownNCT00946543Updated Aug 26, 2013

Intensity-Modulated Radiation Therapy in Treating Patients With Prostate Cancer

A Phase 1 interventional study of hypofractionated radiation therapy and intensity-modulated radiation therapy in Prostate Cancer, sponsored by Royal Marsden NHS Foundation Trust. Status unknown at 3 sites in United Kingdom. Open to male participants. Per ClinicalTrials.gov, last updated 2013-08-26.

Sponsored by Royal Marsden NHS Foundation Trust · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
198
Sex
Male
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Study 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.

PURPOSE: This phase I trial is studying the best dose of intensity-modulated radiation therapy in treating patients with prostate cancer.

Read the detailed description

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 of study treatment, patients are followed up every 6 months for 5 years and then annually thereafter.

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Conditions studied

  • Prostate Cancer

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Keywords

  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
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In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 198 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Royal Marsden NHS Foundation Trust is the lead sponsor of 262 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No

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)
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Study design

Phase
Phase 1
Primary purpose
Treatment
Enrollment
198 participants (estimated)

Interventions

  • Radiationhypofractionated radiation therapy
  • Radiationintensity-modulated radiation therapy
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What researchers measure

Primary outcomes

  1. Late RTOG radiotherapy toxicity as assessed at 6, 12, 18, and 24 months and then annually thereafter

Secondary outcomes

  1. Overall survival

  2. Local control

  3. PSA control

  4. Acute side effects as assessed weekly by the RTOG scoring system

  5. Quality of life

  6. Patterns of recurrence

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Study locations

3 of 3 sites recruiting
  • Institute of Cancer Research - Chelsea
    London, England SW3 6JB, United Kingdom
    • Contact Person · Contact · 44-20-7352-8133
    Recruiting
  • Institute of Cancer Research - Sutton
    Sutton, England SM2 5NG, United Kingdom
    • Contact Person · Contact · 44-181-643-8901
    Recruiting
  • Royal Marsden - Surrey
    Sutton, England SM2 5PT, United Kingdom
    • David P. Dearnaley, MD, FRCP, FRCR · Contact · 44-20-8661-3271
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00946543
Lead sponsor
Royal Marsden NHS Foundation Trust
First posted
Jul 27, 2009
Start date
Mar 2000
Primary completion
Mar 2010 (estimated)
Last update
Aug 26, 2013

Study contacts

David P. Dearnaley, MD, FRCP, FRCR
principal investigator · Royal Marsden NHS Foundation Trust
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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