CyberKnife® as Monotherapy or Boost SBRT for Intermediate or High Risk Localized Prostate Cancer

NCT ID: NCT01985828

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-19
• Study Completion Date: 2019-08-31

Brief Summary

The primary objective of this study is to document the effectiveness of Cyberknife stereotactic body radiotherapy (SBRT) in the treatment of intermediate and high-risk localized prostate cancer defined by biochemical Disease-Free Survival (bDFS), using Phoenix and American Society of Therapeutic Radiation and Oncology (ASTRO) definitions, at 5 years.

During the prostate-specific antigen era, an ever-increasing percentage of men with prostate cancer have presented with clinically localized, potentially curable disease. Although conventional treatment options are potentially curative in selected patients, these treatments also have drawbacks, including the risk of negative long-term quality of life consequences and serious complications.

The CyberKnife® system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal.

Intermediate risk patients will be treated with either CyberKnife® Stereotactic Body Radiation Therapy (SBRT) monotherapy or CyberKnife® SBRT boost followed by Intensity Modulated Radiation Therapy (IMRT). High risk patients will be treated with CyberKnife® SBRT boost followed by IMRT. Treatment will last 4-7 days. Patients will complete the QOL questionnaires before treatment. Questionnaires will also be completed during follow-up visits at 1, 3 , 6, 12, 18, 24, 30 and 36 months then every 12 months until year 5.

Detailed Description

The purpose of this project is to evaluate the efficacy and Health-Related Quality of Life (HRQOL) in intermediate and high-risk prostate cancer patients treated with SBRT as monotherapy or as a boost in combination with IMRT.

Conditions

Prostate Adenocarcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intermediate Risk

Short term (4-6 months) androgen deprivation therapy (ADT) per current standard of care + CyberKnife 21 Gy (7 Gy x 3) and Prostate/SV Intensity Modulated radiation therapy (IMRT) 45-50.4 Gy

OR

Short term (4-6 months)androgen deprivation therapy + CyberKnife 36.35 Gray (7.27 Gray x 5)

Group Type: EXPERIMENTAL

CyberKnife

Intervention Type: RADIATION

Androgen Deprivation Therapy (ADT)

Intervention Type: OTHER

Intensity Modulated radiation therapy (IMRT)

Intervention Type: RADIATION

Per current standard of care

High Risk

Short or Long term (6 months - 3 years) androgen deprivation therapy (ADT) + 45-50.4 Gy and Pelvis Intensity Modulated radiation therapy (IMRT) per current standard of care + 21 Gy (7 Gy x 3) CyberKnife boost

Group Type: EXPERIMENTAL

CyberKnife

Intervention Type: RADIATION

Androgen Deprivation Therapy (ADT)

Intervention Type: OTHER

Intensity Modulated radiation therapy (IMRT)

Intervention Type: RADIATION

Per current standard of care

Interventions

CyberKnife

Intervention Type: RADIATION

Androgen Deprivation Therapy (ADT)

Intervention Type: OTHER

Intensity Modulated radiation therapy (IMRT)

Per current standard of care

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Patient must be ≥ 18 years of age.
• Histologically proven prostate adenocarcinoma

• Gleason score 2-10 (reviewed by reference lab)
• Biopsy within one year of date of registration
• Clinical stage T1b-T4, N0-Nx, M0-Mx (AJCC 7th Edition)
• T-stage and N-stage determined by physical exam and available imaging studies (ultrasound, CT, and/or MRI; see section 4.5)
• M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases.
• PSA ≤ 50 ng/ml, CBC, platelets, BUN, creatinine prior to treatment
• Patients belonging in one of the following risk groups:

• Intermediate: CS T2b-c and Gleason <6 and PSA ≤ 10, or CS T1b-T2b, and Gleason 7 and PSA ≤ 10 ng/ml, or Gleason <6 and PSA 11-20 ng/ml
• High: CS T3-4, Gleason score >7and PSA<50
• Prostate volume: ≤ 100 cc

• Determined using: volume = π/6 x length x height x width
• Measurement from MRI, CT or ultrasound prior to registration.
• ECOG performance status 0-1
• No prior prostatectomy or cryotherapy of the prostate
• No prior radiotherapy to the prostate or lower pelvis
• No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
• No chemotherapy for a malignancy in the last 5 years.
• No history of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arica Hirsch, MD

Role: PRINCIPAL_INVESTIGATOR

Advocate Lutheran General Hospital

Majid M Mohiuddin, MD

Role: STUDY_CHAIR

Advocate Lutheran General Hospital

Locations

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5307

Identifier Type: -

Identifier Source: org_study_id