Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer (RAD 1203)

Prostate Cancer Clinical Trial

Official title:

RAD 1203: Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01856855
• Other study ID #: F121218006
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: December 2022

Study information

• Verified date: December 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the safety, tolerability, and effectiveness of giving a higher dose to the part of the prostate which contains the cancer while giving a standard radiation dose to the entire prostate. The investigators have hypothesized that this treatment technique will effectively control the prostate cancer while minimizing the side effects.

Description:

Objectives:

Primary

-Clinically assess the early toxicity of SBRT with integrated boost for clinically localized prostate cancer

Secondary

• Determine the technical feasibility of stereotactic body radiotherapy (SBRT) with integrated boost for clinically localized prostate cancer

• Determine the treatment planning and dosimetric feasibility

• Evaluate the treatment delivery quality assurance

• Clinically assess early efficacy, late toxicity, and quality of life for patients receiving SBRT with integrated boost for clinically localized prostate cancer

Patients will undergo 5 total radiation treatments over 7-17 day period.

Patients will be asked to complete American Urological Association Symptom Index (AUA SI), Sexual Health Inventory of Men (SHIM), and the Expanded Prostate Index Composite (EPIC)questionnaires. The EPIC assesses bowel, urinary, and sexual function. These questionnaires will be completed at the following time points: Baseline, AUA SI will be collected on the last day of treatment, and every 3 months for the first year following the start of radiation, then every 6 months for year 2.

After completion of study therapy, patients are followed-up every 3 months for the first year, then every 6 months for year 2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• All patients must have Histologically confirmed prostate adenocarcinoma, with biopsies obtained within twelve months of patient registration

• NCCN risk category very low, low, or intermediate risk

• Combined Gleason score <7

• PSA within three months of enrollment < 20ng/ml

• Clinical stage T1a-c N0M0 or clinical stage T2aN0M0

• Life expectancy > 5 years

• Risk of malignant lymph node involvement < 15% as calculated on Partin tables

• Karnofsky performance status (KPS) > 60

• Age > 19 years

• Subjects given written informed consent

Exclusion Criteria:

• History of inflammatory bowel disease

• Prior radical prostate surgery, transurethral resection of the prostate(TURP), or prostate cryotherapy

• Patients using immunosuppressive medications or other medications that may increase radiation toxicity such as methotrexate, sirolimus, tacrolimus, or colchicine that are unable to discontinue these medications during SBRT course. Use of corticosteroids are not considered an exclusion criteria.

• Platelet count < 70

• Patients unable to discontinue anti-platelet or anti-coagulant medicine such as clopidogrel, dabigatran, warfarin, or low molecular weight heparin. Use of aspirin is not an exclusion criteria.

• Pre-SBRT prostate volume > 120 cc as estimated by trans-rectal ultrasound at time of prostate biopsy (TRUS biopsy).

• Risk of malignant lymph node involvement > 15% as calculated on Partin tables.

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms
• Radiation Toxicity
• Sexual Dysfunction

Intervention

Radiation:
• Stereotactic Body Radiation Therapy with Integrated Boost
SBRT with Integrated boost at 7.25 Gy and 8.00 Gy per fraction for five fractions

Locations

Country	Name	City	State
United States	Hazelrig-Salter Radiation Oncology Center	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
John Fiveash, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients Who Experienced Early Toxicity of SBRT With Integrated Boost for Localized Prostate Cancer	Early toxicity (defined as events occurring within 90 days of therapy) will be assessed by physician history and physical exams and patient toxicity/quality-of-life questionnaires to be administered at regular intervals.	Within 3 months of the completion of radiation therapy
Secondary	Treatment Planning Feasibility	Feasibility will be defined as the ability of the treatment planner to create a plan that meets the following criteria: 100% of radiation target prescription (36.25 Gy) covers greater than or equal to 95% of the target (prostate); At least 95% of the boost prostate (area within the prostate most likely harboring cancer) prescription (38.0 Gy) covers 95% of this boost target volume; All normal tissue dose constraints are met -i.e., nearby rectum, bladder, and femoral heads do not exceed the recommended radiation dose limits; If the physician must utilize a plan that compromises target coverage or normal tissue dose constraints to levels not meeting the criteria above, then the plan will be scored as not meeting technical feasibility requirements.	Within 6 months of completion of radiation therapy
Secondary	Early Efficacy	Efficacy will be defined as the absence of biochemically detected (via PSA lab testing) prostate cancer or clinically detected prostate cancer at each interval follow-up visit (every three months for year one, then every 6 months for year two after treatment). "Absence of prostate cancer" is defined as no evidence of tumor recurrence by two methods: No prostate cancer recurrence evident on the physical examination performed by the physician.; No rise in the PSA more than 2 ng/ml above the lowest PSA value ever obtained pre or post treatment. A rise in the PSA more than 2 ng/ml from a patient's lowest value is the standard definition for post-radiation PSA biochemical prostate cancer failure.	Within 6 months of completion of radiation therapy
Secondary	Number of Patients Who Experienced Late Toxicity	Late toxicity (defined as toxicity occuring >90 days after treatment) will be assessed with regular clinical exams and patient toxicity questionnaires.	Within 6 months of completion of radiation therapy
Secondary	Median Quality of Life Score	Median of quality of life score will be assessed with regular clinical exams and patient quality of life questionnaires (American Urologic Association Symptom Index score ranges from 0 to 35 with the higher scores indicating more severe, Sexual Health Inventory score ranges from 1 to 25 with 1 being severe and 25 being no signs, Extended Prostate Cancer Index Composite- Bowel, Extended Prostate Cancer Index Composite- Urinary, and Extended Prostate Cancer Index Composite- Sexual scales range from 1 (worst) to 100 (best)).	Within 6 months of completion of radiation therapy