Prostate CancerPhase 2NCT01045148
CyberKnife Radiosurgery for Localized Prostatic Carcinoma
A Phase 2 study testing CyberKnife Radiosurgery in people with Prostate Cancer, run by CyberKnife Centers of San Diego at 1 site in United States.
Trial summary
Virtual high dose rate (HDR) CyberKnife (CK) prostate treatment has comparable morbidity and efficacy compared with actual prostate HDR treatment, but does it without the catheters and hospital admission. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- 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
- 258 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Dec 2020
- Phase
- Phase 2
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate, clinical stage T1b - T2b (AJCC 6th Edition, see Appendix II), NX/N0, M0.
- Karnofsky performance status > 80.
- Patient must be ≥ 18 years of age.
- Gleason Sum < or = 7
- Prostate-specific antigen < or = 20 ng/ml
- Patients must sign a study-specific informed consent form prior to study entry.
Who cannot join
- Stage < T1b, T2c, T3 or T4 disease (AJCC 6th Edition, see Appendix II).
- Gleason Score > 7.
- PSA > 20 ng/ml.
- Lymph node involvement (N1).
- Evidence of distant metastases (M1).
- Radical surgery for carcinoma of the prostate, prior pelvic radiation, pelvic surgical clips or other metallic foreign bodies.
Show all 11Show fewer
- History of hormonal therapy (antiandrogen or 5 alpha reductase treatment within three months prior to treatment).
- Previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for ≥ 5 years.
- Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
- Metallic Hip prosthesis.
- History of inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
CyberKnife Centers of San Diego
San Diego, California, 92024
Carlyn A Tripp, 619-230-0400 ext. 224, ctripp@genhp.com
Donald B Fuller, M.D.
About this study
Official title: Virtual HDR CyberKnife Radiosurgery for Localized Prostatic Carcinoma: A Phase II Study
Virtual high dose rate (HDR) CyberKnife (CK) prostate treatment has comparable morbidity and efficacy compared with actual prostate HDR treatment, but does it without the catheters and hospital admission. As such, it is a more "patient friendly" treatment method compared with actual prostate HDR brachytherapy as currently practiced. Related, as has previously been reported with actual prostate HDR treatment, Virtual HDR CyberKnife prostate treatment should have a high efficacy but with lower acute and chronic morbidity compared with other local prostate cancer treatment methods such as permanent seed prostate brachytherapy.
Read the detailed description
Brachytherapy is a form of treatment where a radioactive isotope is implanted directly into a tumor volume to deliver a lethal dose of radiation. High Dose Rate (HDR) Prostate brachytherapy is a particularly elegant brachytherapy dose sculpting method that is effectively used in the curative treatment of prostate cancer; however, it requires hospital admission and many temporarily implanted transperineal catheters to deliver the radiation source to the target volume, resulting in significant patient discomfort. CyberKnife delivers a form of radiation treatment that is so precise, it appears capable of reconstructing HDR prostate radiation dose sculpting, without the hospital admission and without the catheters. The CyberKnife device is also used for classic radiosurgery, with accuracy comparable to the Gamma Knife, but unlike the Gamma Knife, has the capability to target lesions anywhere in the body with similar accuracy. The aim of this study is to compare CyberKnife morbidity and efficacy with that of HDR and other local treatment methods such a permanent seed prostate brachytherapy in the treatment of prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- CyberKnife Radiosurgery
- Keywords
- Prostatic Cancer, Prostatic Neoplasms, Prostate Neoplasms, Cancer of the Prostate
- 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
High Dose 3800 cGy/4 fractions
CyberKnife RadiosurgeryRadiation
Moderate Dose 3400 cGy/5 fractions
| Study group | Role | What they receive |
|---|---|---|
| CyberKnife Radiosurgery | Other | CyberKnife Radiosurgery Receives: Radiation: CyberKnife Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of CK prostate radiosurgery in terms of morbidity/QOL, relative to other commonly used methods of prostate cancer treatment and the pattern of PSA decline and biochemical relapse-free survival thereafter.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startMar 2006
- Primary completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CyberKnife Centers of San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlyn Tripp, CyberKnife Centers of San Diego
- Investigators
- Donald B Fuller, M.D., Principal investigator, CyberKnife Centers of San Diego/Radiation Medical Group- Genesis Healthcare Partners
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045148
- Sponsor's protocol ID
- Virtual HDR CK Radiosurgery
- Status last verified
- Jul 2017
- First submitted
- 6 Jan 2010
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
De Bari B, Daidone A, Alongi F. Is high dose rate brachytherapy reliable and effective treatment for prostate cancer patients? A review of the literature. Crit Rev Oncol Hematol. 2015 Jun;94(3):360-70. doi: 10.1016/j.critrevonc.2015.02.003. Epub 2015 Feb 17.
PubMed 25819287
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual HDR CyberKnife Radiosurgery for Localized Prostatic Carcinoma: A Phase II Study
- ClinicalTrials.gov ID
- NCT01045148
- Acronym / sponsor ID
- Virtual HDR CK Radiosurgery
- Conditions
- Prostate Cancer
- Keywords
- Prostatic Cancer, Prostatic Neoplasms, Prostate Neoplasms, Cancer of the Prostate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- CyberKnife Centers of San DiegoUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Dec 2020 (estimated)
- First posted
- 8 Jan 2010 (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.
Virtual high dose rate (HDR) CyberKnife (CK) prostate treatment has comparable morbidity and efficacy compared with actual prostate HDR treatment, but does it without the catheters and hospital admission. As such, it is a more "patient friendly" treatment method compared with actual prostate HDR brachytherapy as currently practiced. Related, as has previously been reported with actual prostate HDR treatment, Virtual HDR CyberKnife prostate treatment should have a high efficacy but with lower acute and chronic morbidity compared with other local prostate cancer treatment methods such as permanent seed prostate brachytherapy.
Detailed description
Brachytherapy is a form of treatment where a radioactive isotope is implanted directly into a tumor volume to deliver a lethal dose of radiation. High Dose Rate (HDR) Prostate brachytherapy is a particularly elegant brachytherapy dose sculpting method that is effectively used in the curative treatment of prostate cancer; however, it requires hospital admission and many temporarily implanted transperineal catheters to deliver the radiation source to the target volume, resulting in significant patient discomfort. CyberKnife delivers a form of radiation treatment that is so precise, it appears capable of reconstructing HDR prostate radiation dose sculpting, without the hospital admission and without the catheters. The CyberKnife device is also used for classic radiosurgery, with accuracy comparable to the Gamma Knife, but unlike the Gamma Knife, has the capability to target lesions anywhere in the body with similar accuracy. The aim of this study is to compare CyberKnife morbidity and efficacy with that of HDR and other local treatment methods such a permanent seed prostate brachytherapy in the treatment of prostate cancer.
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 | Other | Radiation: CyberKnife RadiosurgeryCyberKnife Radiosurgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed adenocarcinoma of the prostate, clinical stage T1b - T2b (AJCC 6th Edition, see Appendix II), NX/N0, M0.
- Karnofsky performance status > 80.
- Patient must be ≥ 18 years of age.
- Patients must sign a study-specific informed consent form prior to study entry.
Key exclusion criteria (11 listed)
- Stage < T1b, T2c, T3 or T4 disease (AJCC 6th Edition, see Appendix II).
- Gleason Score > 7.
- PSA > 20 ng/ml.
- Lymph node involvement (N1).
- Evidence of distant metastases (M1).
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 RadiosurgeryHigh Dose 3800 cGy/4 fractions | Radiation | CyberKnife Radiosurgery |
| CyberKnife RadiosurgeryModerate Dose 3400 cGy/5 fractions | Radiation | CyberKnife Radiosurgery |
Primary outcome
To evaluate the effects of CK prostate radiosurgery in terms of morbidity/QOL, relative to other commonly used methods of prostate cancer treatment and the pattern of PSA decline and biochemical relapse-free survival thereafter.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Derived from this study: PubMed 25819287De Bari B, Daidone A, Alongi F. Is high dose rate brachytherapy reliable and effective treatment for prostate cancer patients? A review of the literature. Crit Rev Oncol Hematol. 2015 Jun;94(3):360-70. doi: 10.1016/j.critrevonc.2015.02.003. Epub 2015 Feb 17.
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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.
Donald B Fuller, M.D. principal investigator
CyberKnife Centers of San Diego/Radiation Medical Group- Genesis Healthcare Partners
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CyberKnife Radiosurgery in people with Prostate Cancer, run by CyberKnife Centers of San Diego 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 6 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 21 Jul 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Carlyn A Tripp (619-230-0400 ext. 224, ctripp@genhp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effects of CK prostate radiosurgery in terms of morbidity/QOL, relative to other commonly used methods of prostate cancer treatment and the pattern of PSA decline and biochemical relapse-free survival thereafter. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01045148, which also lists 1 linked publication.
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 21 Jul 2017.