Prostate CancerNCT02225262
A Phase II Trial of CyberKnife Stereotactic Radiosurgery to Prostate Tumors
A study testing CyberKnife Radiosurgery in people with Prostate Cancer and Cancer of the Prostate, run by Community Cancer Center, Normal, Illinois at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Cancer, Cancer of the Prostate, Prostate Neoplasm
- What is being tested?
- CyberKnife Radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating Homogenous Dose Distribution
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.
Read the detailed description
The CyberKnife system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays (radiation) 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.
- Conditions
- Prostate Cancer, Cancer of the Prostate, Prostate Neoplasm
- Being tested
- CyberKnife Radiosurgery
- Keywords
- Prostate cancer, CyberKnife, Stereotactic, Radiation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyberKnife RadiosurgeryRadiation
Also called CyberKnife
36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
| Study group | Role | What they receive |
|---|---|---|
| CyberKnife Radiosurgery | Experimental | Not described Receives: Radiation: CyberKnife Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5-10 years
Secondary outcomes (1)
Overall survival
To measure the following in the study population: rates of local failure, distant failure, disease-free survival, disease-specific survival; quality of life (QOL) in generic and organ-specific domains.
Measured: 5-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startJan 2008
- Primary completionJan 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Community Cancer Center, Normal, Illinois
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shermian Woodhouse, MD, Principal investigator, Community Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225262
- Sponsor's protocol ID
- CK Prostate-01
- Status last verified
- Jul 2019
- First submitted
- 22 Aug 2014
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating Homogenous Dose Distribution
- ClinicalTrials.gov ID
- NCT02225262
- Acronym / sponsor ID
- CK Prostate-01
- Conditions
- Prostate Cancer, Cancer of the Prostate, Prostate Neoplasm
- Keywords
- Prostate cancer, CyberKnife, Stereotactic, Radiation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Community Cancer Center, Normal, IllinoisUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The CyberKnife system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays (radiation) 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CyberKnife Radiosurgery | Experimental | Radiation: CyberKnife Radiosurgery |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- Any histology other than adenocarcinoma
- Age < 21
- KPS <= 40 <70
- ECOG Performance Status ≥ 2
- Patient weight >350 lbs. (table limitation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyberKnife RadiosurgeryAlso: CyberKnife36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction | Radiation | CyberKnife Radiosurgery |
Primary outcome
Local control rate
Time frame: 5-10 years
* 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.
1 secondary outcome
Overall survival
Time frame: 5-10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shermian Woodhouse, MD principal investigator
Community Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CyberKnife Radiosurgery in people with Prostate Cancer and Cancer of the Prostate, run by Community Cancer Center, Normal, Illinois at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control rate (time frame: 5-10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.