Hypo-fractionated Stereotactic Body Radiotherapy for Localized Prostate Cancer

NCT01059513 | Completed DMC

• 1 other identifier: 10-001787
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

T1c; T2a; T2b

Outcome Measures

Primary Outcomes (1)

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

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.
• No life expectancy restrictions will apply.
• Performance status will not be considered.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

UCLA Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Christopher King, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2010
• First Posted: February 1, 2010
• Study Start: January 26, 2010
• Primary Completion: March 19, 2020
• Study Completion: March 19, 2020
• Last Updated: November 25, 2020

Record last verified: 2020-05

Locations

US (1)