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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04915508
Other study ID # 21-000263
Secondary ID NCI-2021-05447
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 23, 2021
Est. completion date August 1, 2027

Study information

Verified date July 2023
Source Jonsson Comprehensive Cancer Center
Contact Brian Carlton
Phone (925)212-7215
Email bcarlton@mednet.ucla.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial investigates the effect of extremely hypofractionated intensity modulated stereotactic body radiotherapy in treating patients with prostate cancer that has rising prostate specific antigen (PSA) after radical prostatectomy. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Hormone Therapy
Receive hormonal therapy
Radiation:
Stereotactic Body Radiation Therapy
Undergo SBRT

Locations

Country Name City State
United States UCLA / Jonsson Comprehensive Cancer Center Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of Expanded Prostate Cancer Index (EPIC) score for the gastrointestinal domain EPIC assessed the disease-specific aspects of prostate cancer and its therapies within the gastrointestinal summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL. Baseline up to 2 years
Primary Change of Expanded Prostate Cancer Index (EPIC) score for the genitourinary domain EPIC assessed the disease-specific aspects of prostate cancer and its therapies within the genitourinary summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL. Baseline up to 2 years
Secondary Patient-reported gastrointestinal (GI) symptoms EPIC assessed the disease-specific aspects of prostate cancer and its therapies within the gastrointestinal summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL. At 3 months, 6 months, 1year, and 5 years
Secondary Patient-reported genitourinary (GU) symptoms EPIC assessed the disease-specific aspects of prostate cancer and its therapies within the genitourinary summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL. At 3 months, 6 months, 1year, and 5 years
Secondary Incidence of acute physician scored adverse events Will be assessed by using the Common Terminology Criteria for Adverse Events version 4.0. Up to 5 years
Secondary Cumulative incidence of physician scored adverse events Will be assessed by using the Common Terminology Criteria for Adverse Events version 4.0. Up to 5 years
Secondary Progression-free survival Up to 5 years
Secondary Cumulative incidence of biochemical recurrence Up to 5 years
Secondary Distant metastasis-free survival Up to 5 years
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