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

Prostate Adenocarcinoma Clinical Trial

Official title:

Prospective Evaluation of CyberKnife® as Monotherapy or Boost Stereotactic Body Radiotherapy for Intermediate or High Risk Localized Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01985828
• Other study ID #: 5307
• Status: Recruiting
• Phase: N/A
• Start date: November 19, 2013
• Est. completion date: December 2026

Study information

• Verified date: July 2021
• Source: Advocate Health Care
• Contact: Arica Hirsch, MD
• Phone: 847-723-8030
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 2026
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

• 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 = p/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.

Related Conditions & MeSH terms

• Prostate Adenocarcinoma
• Prostatic Neoplasms

Intervention

Radiation:
• CyberKnife

Other:
• Androgen Deprivation Therapy (ADT)

Radiation:
• Intensity Modulated radiation therapy (IMRT)
Per current standard of care

Locations

Country	Name	City	State
United States	Advocate Lutheran General Hospital	Park Ridge	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Advocate Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life (QOL) in generic and organ-specific domains		5 years
Primary	Biochemical Disease-Free Survival (bDFS), using Phoenix and ASTRO definitions		5 years
Secondary	Measure the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity		5 years
Secondary	Measure local failure rates	Measurement of local recurrence of prostate cancer	5 years
Secondary	Measure distant failure rates	Measurement of distant metastasis rate	5 years
Secondary	Measure clinical disease-free survival rates		5 years
Secondary	Measure disease-specific survival rates		5 years
Secondary	Measure Overall Survival		5 years