NCT00946543

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

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for phase_1 prostate-cancer

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
9.4 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Last Updated

August 26, 2013

Status Verified

July 1, 2009

Enrollment Period

10 years

First QC Date

July 24, 2009

Last Update Submit

August 23, 2013

Conditions

Prostate Cancer

Keywords

stage IIB prostate cancerstage IIA prostate cancerstage III prostate cancerstage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

  • Overall survival

  • Local control

  • PSA control

  • Acute side effects as assessed weekly by the RTOG scoring system

  • Quality of life

  • +1 more secondary outcomes

Interventions

hypofractionated radiation therapyRADIATION
intensity-modulated radiation therapyRADIATION

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Institute of Cancer Research - Chelsea

London, England, SW3 6JB, United Kingdom

RECRUITING

Institute of Cancer Research - Sutton

Sutton, England, SM2 5NG, United Kingdom

RECRUITING

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38997466DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • David P. Dearnaley, MD, FRCP, FRCR

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2009

First Posted

July 27, 2009

Study Start

March 1, 2000

Primary Completion

March 1, 2010

Last Updated

August 26, 2013

Record last verified: 2009-07

Locations

GB(3)