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

NCT01856855 | Completed Results DMC

• 1 other identifier: F121218006
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer; Prostate Adenocarcinoma; Radiation Toxicity; Sexual Dysfunction

Keywords

Prostate Cancer; Prostate Adenocarcinoma; Radiation; SBRT; Stereotactic Body Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Treatment Planning Feasibility

  Within 6 months of completion of radiation therapy

• Early Efficacy

  Within 6 months of completion of radiation therapy

• Number of Patients Who Experienced Late Toxicity

  Within 6 months of completion of radiation therapy

• Median Quality of Life Score

  Within 6 months of completion of radiation therapy

Study Arms (1)

Stereotactic Body Radiation Therapy with Integrated Boost

EXPERIMENTAL

Radiation: Stereotactic Body Radiation Therapy with Integrated Boost

Interventions

Stereotactic Body Radiation Therapy with Integrated Boost RADIATION

SBRT with Integrated boost at 7.25 Gy and 8.00 Gy per fraction for five fractions

Also known as: SBRT, IMRT, VMAT

Stereotactic Body Radiation Therapy with Integrated Boost

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of inflammatory bowel disease
• Prior radical prostate surgery, transurethral resection of the prostate(TURP), or prostate cryotherapy
• Platelet count \< 70
• 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.

Sponsors & Collaborators

• John Fiveash, MD: lead

Study Sites (1)

Hazelrig-Salter Radiation Oncology Center

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Radiation Injuries; Sexual Dysfunction, Physiological

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: John Fiveash, MD
• Organization: University of Alabama at Birmingham (UAB)

jfiveash@uabmc.edu

(205) 975-0224

Study Officials

• John B Fiveash, MD

  University of Alabama at Birmingham Radiation Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Vice Chair, University of Alabama at Birmingham Department of Radiation Oncology

Study Record Dates

• First Submitted: April 10, 2013
• First Posted: May 17, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: January 12, 2023
• Results First Posted: January 12, 2023

Record last verified: 2022-12

Locations

US (1)