Recurrent Prostate CancerPhase 2NCT00851916
CyberKnife Radiosurgery for Locally Recurrent Prostate CA
A Phase 2 study testing CyberKnife Radiosurgery in people with Recurrent Prostate Cancer, run by CyberKnife Centers of San Diego at 1 site in United States.
Trial summary
The purpose of this study is to scientifically evaluate the effects (good and bad) of a new type of radiation treatment in patients with locally recurrent prostate cancer after prior radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Recurrent 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Feb 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed recurrent adenocarcinoma of the prostate, clinical stage T1 - T3 (AJCC 6th Edition, see Appendix II), NX/N0, M0, following prior prostate radiotherapy.
- Karnofsky performance status >80.
- Greater than 5 year life expectancy
- Greater than 2 years since the original course of radiotherapy.
- Absence of distant metastases by radiologic or pathologic assessment.
- Absence of lymph node involvement by radiologic or pathologic assessment.
- Patients must sign a study-specific informed consent form prior to study entry.
Who cannot join
- Stage T4 disease (AJCC 6th Edition, see Appendix II).
- Less than 2 years since the original course of radiotherapy.
- Lymph node involvement (N1).
- Evidence of distant metastases (M1).
- Radical surgery for carcinoma of the prostate
- Previous or concurrent cancers other than basal, in situ, or squamous cell skin cancers unless disease-free for ≥ 5 years.
Show all 9Show fewer
- Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
- History of inflammatory bowel disease
- Late GI or GU Morbidity > Grade 1 from the prior course of radiotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
CybeKnife Centers of San Diego
San Diego, California, 92024
Donald B. Fuller, M.D.
About this study
Official title: VIRTUAL HDR CYBERKNIFE RADIOSURGERY FOR LOCALLY RECURRENT PROSTATIC CARCINOMA: A PHASE II STUDY
The purpose of this study is to scientifically evaluate the effects (good and bad) of a new type of radiation treatment in patients with locally recurrent prostate cancer after prior radiotherapy. The treatment is known as prostate radiosurgery, and is distinguished from traditional radiotherapy by the application of smaller, more precisely controlled margins around the area targeted for full dose radiation, and far fewer treatments, using a much larger dose per treatment.
This research is being done to see what advantages, if any, prostate radiosurgery may have over other salvage treatment methods, including brachytherapy, cryosurgery, high intensity focused ultrasound (HIFU), hormonal therapy and radical prostatectomy.
- Conditions
- Recurrent Prostate Cancer
- Being tested
- CyberKnife Radiosurgery
- 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
CyberKnife Radiosurgery
| Study group | Role | What they receive |
|---|---|---|
| CyberKnife Radiosurgery | Other | Single arm study using CyberKnife radiosurgery to treat recurrent prostate cancer patients that have already received external beam radiotherapy. Receives: Radiation: CyberKnife Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish pattern of PSA decline
Measured: Post CyberKnife Radiosurgery - 5 year f/up
Secondary outcomes (1)
Quality of Life realitive to other commonly used radiation treatment methods for recurrent prostate cancer
Measured: Post CyberKnife Radiosurgery/5 yr. f/up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent 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
- 20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851916
- Sponsor's protocol ID
- CK Recurrent Prostate SD
- Status last verified
- Jul 2017
- First submitted
- 25 Feb 2009
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
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 LOCALLY RECURRENT PROSTATIC CARCINOMA: A PHASE II STUDY
- ClinicalTrials.gov ID
- NCT00851916
- Acronym / sponsor ID
- CK Recurrent Prostate SD
- Conditions
- Recurrent Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- CyberKnife Centers of San DiegoUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2020 (estimated)
- First posted
- 26 Feb 2009 (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 scientifically evaluate the effects (good and bad) of a new type of radiation treatment in patients with locally recurrent prostate cancer after prior radiotherapy. The treatment is known as prostate radiosurgery, and is distinguished from traditional radiotherapy by the application of smaller, more precisely controlled margins around the area targeted for full dose radiation, and far fewer treatments, using a much larger dose per treatment.
This research is being done to see what advantages, if any, prostate radiosurgery may have over other salvage treatment methods, including brachytherapy, cryosurgery, high intensity focused ultrasound (HIFU), hormonal therapy and radical prostatectomy.
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 RadiosurgerySingle arm study using CyberKnife radiosurgery to treat recurrent prostate cancer patients that have already received external beam radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed recurrent adenocarcinoma of the prostate, clinical stage T1 - T3 (AJCC 6th Edition, see Appendix II), NX/N0, M0, following prior prostate radiotherapy.
- Karnofsky performance status >80.
- Greater than 5 year life expectancy
- Greater than 2 years since the original course of radiotherapy.
- Absence of distant metastases by radiologic or pathologic assessment.
Key exclusion criteria (9 listed)
- Stage T4 disease (AJCC 6th Edition, see Appendix II).
- Less than 2 years since the original course of radiotherapy.
- Lymph node involvement (N1).
- Evidence of distant metastases (M1).
- Radical surgery for carcinoma of the prostate
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 RadiosurgeryCyberKnife Radiosurgery | Radiation | CyberKnife Radiosurgery |
Primary outcome
Establish pattern of PSA decline
Time frame: Post CyberKnife Radiosurgery - 5 year f/up
1 secondary outcome
Quality of Life realitive to other commonly used radiation treatment methods for recurrent prostate cancer
Time frame: Post CyberKnife Radiosurgery/5 yr. f/up
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.
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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
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 Recurrent 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 7 inclusion and 9 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 Tripp (619-230-0400 ext. 224, ctripp@rmgmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish pattern of PSA decline (time frame: Post CyberKnife Radiosurgery - 5 year f/up). 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 21 Jul 2017.