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

NCT01985828 | Completed Results

• 1 other identifier: 5307
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Adenocarcinoma

Keywords

Prostate neoplasm; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Biochemical Disease-Free Survival (bDFS), Using Phoenix and ASTRO Definitions

  Phoenix definition: Biochemical recurrence of prostate cancer (PCa) after curative radiotherapy defined as a prostate-specific antigen (PSA) rise of ≥2 ng/ml above the nadir. Astro definition: Biochemical failure in prostate cancer defined as three consecutive rises in prostate-specific antigen (PSA) after a nadir.

  3 years

Secondary Outcomes (2)

• Measure the Rates of Acute and Late Grade 3-5 Gastrointestinal and Genitourinary Toxicity

  3 years

• Expanded Prostate Cancer Index Composite Epic-26

  3 years

Study Arms (2)

Intermediate Risk

EXPERIMENTAL

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)

Radiation: CyberKnife; Other: Androgen Deprivation Therapy (ADT); Radiation: Intensity Modulated radiation therapy (IMRT)

High Risk

EXPERIMENTAL

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

Radiation: CyberKnife; Other: Androgen Deprivation Therapy (ADT); Radiation: Intensity Modulated radiation therapy (IMRT)

Interventions

CyberKnife RADIATION

High Risk; Intermediate Risk

Androgen Deprivation Therapy (ADT) OTHER

High Risk; Intermediate Risk

Intensity Modulated radiation therapy (IMRT) RADIATION

Per current standard of care

High Risk; Intermediate Risk

Eligibility Criteria

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

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery; Androgen Antagonists; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted

Results Point of Contact

• Title: Geraldine Lara
• Organization: Advocate Health

geraldine.lara@aah.org

8477238239

Study Officials

• Arica Hirsch, MD

  Advocate Lutheran General Hospital

  PRINCIPAL INVESTIGATOR

• Majid M Mohiuddin, MD

  Advocate Lutheran General Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: November 15, 2013
• Study Start: November 19, 2013
• Primary Completion: September 1, 2018
• Study Completion: August 1, 2019
• Last Updated: October 3, 2024
• Results First Posted: October 1, 2024

Record last verified: 2024-06

Locations

US (1)