Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment radiotherapy with imrt and cyberknife boost
Phase phase 2
Sponsor Georgetown University
Start date November 2009
End date February 2017
Trial size 70 participants
Trial identifier NCT01618851, IRB 2009-599

Summary

This phase II study designed to prospectively evaluate the efficacy and morbidity of IMRT with CyberKnife radiosurgical boosts for clinically localized prostate cancer. Patients will be treated with three radiosurgical treatments (6.5 Gy per fraction) followed by IMRT (45 Gy in 25 fractions).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients with clinically localized prostate cancer will be treated with three radiosurgical treatments (6.5 Gy per fraction to PTV) followed by IMRT (45 Gy in 25 fractions) over 6-7 weeks.
radiotherapy with imrt and cyberknife boost
Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. The prescribed PTV dose of 19.5 Gy shall be given in 3 fractions using the CyberKnife. At least three fiducials should be identified for each treatment. If fewer than three fiducials can be tracked, then additional fiducials will be placed, and the patient replanned. Fiducial locations in the images will be extracted and compared to the fiducial locations in the CT scans to estimate target movements. For IMRT, Daily doses of 180 cGy are to be delivered to the PTV 5 days a week to a total dose of 4500 cGy in 25 fractions.

Primary Outcomes

Measure
Local failure
time frame: 2 years after radiotherapy.

Secondary Outcomes

Measure
Gastrointestinal and genitourinary toxicity
time frame: During 5 years following the CyberKnife SRS treatment for prostate cancer
Biochemical disease-free survival (bDFS)
time frame: 2 years after radiotherapy
Quality of Life
time frame: During the 5 years following radiotherapy

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Histologically confirmed adenocarcinoma of the prostate (Biopsy within one year of enrollment) - Signed Study-Specific COnsent - PSA within 60 days of registration - Baseline AUA score is less than 20 Exclusion Criteria: - Prior Pelvic radiotherapy - Prior Radical Prostate surgery - Recent (within 5 years) or concurrent cancers other than non-melanoma skin cancer - Medical or psychiatric illness that would interfere with treatment or follow-up - Implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and/or treatment delivery.

Additional Information

Official title Phase II Study to Evaluate the Efficacy of Intensity Modulated Radiation Therapy With Hypofractionated Radiosurgical Boosts in the Treatment of Clinically Localized Prostate Cancer
Principal investigator Sean P Collins, MD,PhD
Description This is a phase II study designed to prospectively evaluate the efficacy and morbidity of IMRT with CyberKnife radiosurgical boosts for clinically localized prostate cancer. Patients with clinically localized prostate cancer will be treated with three radiosurgical treatments (6.5 Gy per fraction to the PTV) followed by IMRT (45 Gy in 25 fractions). Treatment will be completed over a 6-7 week period. The hypothesis is that for patients with clinically localized adenocarcinoma of the prostate, CyberKnife Radiosurgery delivered to the prostate is efficacious with acceptable toxicity in combination with IMRT. Subjects will have toxicity evaluation and AUA score on the last day of treatment. At 1 month following treatment, subjects will be assessed for acute toxicity and will fill out AUA form, SF-12, EPIC-26, SHIM and Utilization of Sexual Rx/Devices. At 3, 6, 12, 18 and 24 month intervals (and every 6 months thereafter, through year 5, and annually through year 10, if investigators opt to continue past year 5), subjects will be seen and evaluated, including a history, physical exam, performance status, PSA, toxicity evaluation, and AUA score. In addition, at 6 months, 12 months and annually thereafter, the SF-12, EPIC-26, SHIM and Utilization of Sexual Medications/Devices will be administered. A prostate biopsy will be performed at time of biochemical or local clinical failure, and is encouraged at 2 years following treatment and at time of distant failure. A bone scan will be performed at the time of biochemical failure, or when the subject develops signs of symptoms suggesting metastatic disease. Acute side effects (≤ 90 days of treatment start) will be assessed using the NCI Toxicity Criteria version 3.0.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Georgetown University.