Phase II Study to Evaluate Conventional Radiation Therapy Followed by Radiosurgical Boost in Clinically Localized Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sean Collins, M.D., PhD, Georgetown University
ClinicalTrials.gov Identifier:
NCT01618851
First received: June 12, 2012
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention Phase
Prostate Cancer
Radiation: Radiotherapy with IMRT and CyberKnife Boost
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Local failure [ Time Frame: 2 years after radiotherapy. ] [ Designated as safety issue: No ]
    To estimate the rate of local failure as assessed by 2 year post-radiotherapy prostate biopsies. (Studies with the CyberKnife radiosurgery would be worthwhile for prostate cancer patients if the rate of local control was > 70%)


Secondary Outcome Measures:
  • Gastrointestinal and genitourinary toxicity [ Time Frame: During 5 years following the CyberKnife SRS treatment for prostate cancer ] [ Designated as safety issue: No ]
    To estimate the proportion of patients who develop late grade 3-5 gastrointestinal and genitourinary toxicity observed during the five years following CyberKnife SRS for prostate cancer.

  • Biochemical disease-free survival (bDFS) [ Time Frame: 2 years after radiotherapy ] [ Designated as safety issue: No ]
    To assess secondary efficacy endpoints: Biochemical disease-free survival (bDFS) assessed using both Phoenix and ASTRO definitions, disease-free survival, disease-specific survival, time to failure, overall survival, duration of local control, and proportion of distant failure at 2 years.

  • Quality of Life [ Time Frame: During the 5 years following radiotherapy ] [ Designated as safety issue: No ]
    To evaluate Quality of life (QOL).


Estimated Enrollment: 70
Study Start Date: November 2009
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMRT with SBRT Boost
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.
Radiation: 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.


Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618851

Locations
United States, District of Columbia
MedStar Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: Sean P Collins, MD,PhD Georgetown University Hospital
  More Information

No publications provided

Responsible Party: Sean Collins, M.D., PhD, Assistant Professor, Georgetown University
ClinicalTrials.gov Identifier: NCT01618851     History of Changes
Other Study ID Numbers: IRB 2009-599
Study First Received: June 12, 2012
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on October 01, 2014