Prostate CancerPhase 1NCT00969202
Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer
A Phase 1 study testing Stereotactic Radiosurgery using the Novalis Tx in people with Prostate Cancer, run by San Diego Radiosurgery at 1 site in United States.
Trial summary
The purpose of this trial is to evaluate a short course of very focused (stereotactic) external beam radiation therapy for the treatment of early stage prostate cancer. The investigators will gather scientific information about the tolerance and side effects this type of radiation. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Stereotactic Radiosurgery using the Novalis Tx
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Dec 2016
- Phase
- Phase 1
- 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 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate
- Gleason score ≤ 6 and low volume Gleason 7 (3+4)
- PSA < 10
- Clinical Stage of T2a or less
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Prior radiation treatment for prostate cancer
- Gleason score > 7
- PSA > 10
- Clinical Stage of T2b or greater
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
San Diego Radiosurgery at Palomar Medical Center
Escondido, California, 92025
Jennifer Joiner, 760-739-3185, Jennifer.joiner@palomarhealth.org
Lori A Coleman, MD
About this study
Official title: Phase 1 Study of Stereotactic Hypofractionated Radiosurgery of Low Grade Prostate Cancer/Early Stage
The purpose of this trial is to evaluate a short course of very focused (stereotactic) external beam radiation therapy for the treatment of early stage prostate cancer.
The investigators will gather scientific information about the tolerance and side effects this type of radiation. The investigators will then compare these results with those of standard 8 week course of external beam radiation therapy to see if this study treatment is equally or more effective in treating prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Stereotactic Radiosurgery using the Novalis Tx
- Keywords
- Prostate Cancer, Cancer of the Prostate, Prostate Tumor, Novalis Tx, Novalis, Stereotactic Radiosurgery, Radiosurgery, 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.
Stereotactic Radiosurgery using the Novalis TxRadiation
Also called Novalis Tx, Novalis
Five treatments given every other day.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Radiosurgery using NovalisTx | Experimental | Single arm study using the Novalis Tx to perform radiosurgery to treat low grade prostate cancer. Receives: Radiation: Stereotactic Radiosurgery using the Novalis Tx |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA decline measured through laboratory testing.
Measured: One month following radiosurgery through 5 year follow up
Secondary outcomes (1)
Quality of life in relation to urinary, bowel and sexual function. Measured through a questionnaire at each follow up visit.
Measured: One month following radiosurgery through 5 years follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2016 (estimated)
- Study completionDec 2016 (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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego Radiosurgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- P. Brian Volpp, MD, MPH, Principal investigator, San Diego Radiosurgery/X-Ray Medical Group-Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969202
- Sponsor's protocol ID
- SDRS0001
- Status last verified
- Nov 2015
- First submitted
- 28 Aug 2009
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Stereotactic Hypofractionated Radiosurgery of Low Grade Prostate Cancer/Early Stage
- ClinicalTrials.gov ID
- NCT00969202
- Acronym / sponsor ID
- SDRS0001
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Cancer of the Prostate, Prostate Tumor, Novalis Tx, Novalis, Stereotactic Radiosurgery, Radiosurgery, Radiation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- San Diego RadiosurgeryIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 Sep 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 trial is to evaluate a short course of very focused (stereotactic) external beam radiation therapy for the treatment of early stage prostate cancer.
The investigators will gather scientific information about the tolerance and side effects this type of radiation. The investigators will then compare these results with those of standard 8 week course of external beam radiation therapy to see if this study treatment is equally or more effective in treating 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 |
|---|---|---|
| Stereotactic Radiosurgery using NovalisTx | Experimental | Radiation: Stereotactic Radiosurgery using the Novalis TxSingle arm study using the Novalis Tx to perform radiosurgery to treat low grade prostate cancer. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed adenocarcinoma of the prostate
- Gleason score ≤ 6 and low volume Gleason 7 (3+4)
- PSA < 10
- Clinical Stage of T2a or less
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (4 listed)
- Prior radiation treatment for prostate cancer
- Gleason score > 7
- PSA > 10
- Clinical Stage of T2b or greater
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 |
|---|---|---|
| Stereotactic Radiosurgery using the Novalis TxAlso: Novalis Tx, NovalisFive treatments given every other day. | Radiation | Stereotactic Radiosurgery using NovalisTx |
Primary outcome
PSA decline measured through laboratory testing.
Time frame: One month following radiosurgery through 5 year follow up
1 secondary outcome
Quality of life in relation to urinary, bowel and sexual function. Measured through a questionnaire at each follow up visit.
Time frame: One month following radiosurgery through 5 years follow up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
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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.
P. Brian Volpp, MD, MPH principal investigator
San Diego Radiosurgery/X-Ray Medical Group-Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stereotactic Radiosurgery using the Novalis Tx in people with Prostate Cancer, run by San Diego Radiosurgery 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 5 inclusion and 4 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 18 Nov 2015. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Jennifer Joiner (760-739-3185, Jennifer.joiner@palomarhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA decline measured through laboratory testing. (time frame: One month following radiosurgery through 5 year follow 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 18 Nov 2015.