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CompletedNCT01059513Updated Nov 25, 2020

Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer

An observational study in Prostate Cancer, sponsored by Jonsson Comprehensive Cancer Center. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-25.

Sponsored by Jonsson Comprehensive Cancer Center · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
167
Ages
18 Years and older
Sex
Male
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Study summary

This is an observational study in which a questionnaire is used to obtain quality of life data after patients undergo a hypo-fractionated course of stereotactic body radiotherapy (SBRT) for the treatment of their prostate cancer. The SBRT itself is considered standard of care for these patients and as such, is not an official component of the study.

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Conditions studied

  • Prostate Cancer

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Keywords

  • T1c
  • T2a
  • T2b
03

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 enrollment of 167 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Eligible patients will have clinical stage T1c, T2a, or T2b, a pre-biopsy PSA level \<10 ng/mL and a biopsy Gleason score of 3+3 (or 3+4 if fewer than 30% of biopsy cores are involved).

Inclusion criteria

  • Eligible patients will have clinical stage T1c, T2a, or T2b, a pre-biopsy PSA level \<10 ng/mL and a biopsy Gleason score of 3+3 (or 3+4 if fewer than 30% of biopsy cores are involved).
  • The ability to understand and willingness to sign a written informed consent are necessary.

Exclusion criteria

Exclusion Criteria:

  • Patients with tumor parameters that fall outside of the inclusion criteria.
  • Patients with evidence on imagining (bone scan, CT, or MRI) suggestive of disseminated disease.
  • Patients who have had any form of prior prostate treatment (surgery, radiotherapy, cryotherapy, high intensity focused ultrasound, TURP).
  • A prior course of hormone therapy (androgen deprivation) of greater than 3 months duration.
  • The use of other concurrent investigational agents.
  • There are no exclusions due to co-morbid disease or illnesses except for patients with severe inflammatory bowel disease.
  • No life expectancy restrictions will apply.
  • Performance status will not be considered.
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Study design

Observational model
Other
Time perspective
Other
Enrollment
167 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. To quantify patient quality of life after prostate SBRT using validated questionnaire tools

    Time frame: 5 years

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Study locations

1 site
  • UCLA Jonsson Comprehensive Cancer Center
    Los Angeles, California 90095, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2020, 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
NCT01059513
Lead sponsor
Jonsson Comprehensive Cancer Center
Responsible party
Sponsor
First posted
Feb 1, 2010
Start date
Jan 26, 2010
Primary completion
Mar 19, 2020
Completion
Mar 19, 2020
Last update
Nov 25, 2020

Study contacts

Christopher King, MD
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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