A Phase II Trial of CyberKnife Stereotactic Radiosurgery to Prostate Tumors

NCT02225262 | Unknown

• 1 other identifier: CK Prostate-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage prostate cancer. The investigators hypothesize that hypofractionated stereotactic radiotherapy via the CyberKnife® can deliver tumor ablating doses of radiation to prostate tumors safely and effectively while sparing the adjacent tissues (rectum, bladder, ureters, urethra, penile bulb, and bowel) from receiving damaging doses of radiation.

Conditions

Prostate Cancer; Cancer of the Prostate; Prostate Neoplasm

Keywords

Prostate cancer; CyberKnife; Stereotactic; Radiation

Outcome Measures

Primary Outcomes (1)

• Local control rate

  * To assess the effects of hypofractionated stereotactic radiosurgery on the long-term local tumor control of prostate cancer (through documentation of the rate of biochemical Disease-Free Survival \[bDFS\], Phoenix and ASTRO definitions, at 5 and 10 years). * To document the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity observed during the years following CyberKnife SRS for prostate cancer.

  5-10 years

Secondary Outcomes (1)

• Overall survival

  5-10 years

Study Arms (1)

CyberKnife Radiosurgery

EXPERIMENTAL

Radiation: CyberKnife Radiosurgery

Interventions

CyberKnife Radiosurgery RADIATION

36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction

Also known as: CyberKnife

CyberKnife Radiosurgery

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male Age ≥ 21
• Histologically proven prostate adenocarcinoma
• Clinical stage T1b-T2b, N0-Nx, M0-Mx (AJCC 6th Edition)
• PSA ≤ 20 ng/ml
• Prostate volume ≤ 100 cc
• Patients belonging in one of the following risk groups:
• Low:
• CS T1b-T2a and Gleason 2-6 and PSA ≤ 10
• Intermediate:
• CS T2b and Gleason 2-6 and PSA ≤ 10, OR
• CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/ml OR Gleason 7 and PSA ≤ 10 ng/ml

You may not qualify if:

• Any histology other than adenocarcinoma
• Age \< 21
• KPS \<= 40 \<70
• ECOG Performance Status ≥ 2
• Patient weight \>350 lbs. (table limitation)
• Prior XRT to prostate or lower pelvis
• Prior surgery or cryotherapy to prostate
• Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
• Chemotherapy for a malignancy in the last 5 years
• History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years
• Hormone ablation for 2 months prior to enrollment, or during treatment

Sponsors & Collaborators

• Community Cancer Center, Normal, Illinois: lead

Study Sites (1)

Community Cancer Center

Normal, Illinois, 61761, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

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

Study Officials

• Shermian Woodhouse, MD

  Community Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2014
• First Posted: August 26, 2014
• Study Start: January 1, 2008
• Primary Completion: January 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

US (1)