NCT00855647

Brief Summary

To demonstrate that a hypo-fractionated course of radiotherapy (ie. an accelerated radiotherapy course where fewer but larger doses of radiotherapy are given) is both safe and effective in the treatment of low-risk localized prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99,999

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2003

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

June 3, 2010

Status Verified

June 1, 2010

Enrollment Period

5.6 years

First QC Date

March 2, 2009

Last Update Submit

June 1, 2010

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • PSA response that achieves a stable nadir over time.

Interventions

Hypo-fractionated RadiotherapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have had any form of prior curative treatment (surgery, radiotherapy, cryotherapy) will not be eligible. A prior course of hormone therapy of less than 3 months duration will be allowed.
  • Adult men will be considered.
  • No life expectancy restrictions will apply.
  • Performance Status will not be considered.
  • No requirements for organ or marrow function will be made

You may not qualify if:

  • The use of other concurrent Investigational Agents will not be allowed.
  • No requirements regarding history of allergic reactions.
  • Pregnancy or nursing patients is not applicable (ie. patients are male).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Christopher R. King

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2009

First Posted

March 4, 2009

Study Start

August 1, 2003

Primary Completion

March 1, 2009

Study Completion

July 1, 2009

Last Updated

June 3, 2010

Record last verified: 2010-06

Locations

US(1)