Prostate CancerNCT01352598
Stereotactic Body Radiotherapy for Prostate Cancer
A study testing stereotactic body radiotherapy in people with Prostate Cancer, run by Mercy Research at 1 site in United States.
Trial summary
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of organ confined prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- stereotactic body radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient age >= 18 years
- Zubrod performance status of 0-3
- T1-3 N0 M0 adenocarcinoma of the prostate
- Prostate volume ≤ 100 cc
- Signed study-specific consent form
Who cannot join
- Extension of local tumor to involve adjacent organs other than seminal vesicles (T4)
- Prostate volume > 100 cc
- Nodal involvement
- Metastatic disease
- Prior pelvic radiotherapy except as part of combination therapy for prostate cancer
- History of scleroderma
- Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of organ confined prostate cancer.
Read the detailed description
This is a single site, non-randomized, prospective, phase IV trial of patients with organ-confined prostate cancer. Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues,tumor recurrence data, and acute and late toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.
- Conditions
- Prostate Cancer
- Being tested
- stereotactic body radiotherapy
- Keywords
- prostate cancer, stereotactic radiotherapy
- 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 body radiotherapyRadiation
Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiotherapy | Other | Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions. Receives: Radiation: stereotactic body radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical Control Rate
Serial blood tests for prostate specific antigen (PSA) levels will be obtained at regular intervals (every 3 months).The "Phoenix definition" for biochemical recurrence (nadir + 2 ng/ml) will be used. Biochemical control rate will be expressed based on subjects experiencing tumor control (complete, partial, or stable) vs. subjects experiencing disease progression.
Measured: one year
Secondary outcomes (1)
Late Toxicity Rate
Toxicity will be recorded as a measure of patients who experienced adverse events within 1 year of study treatment.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study startJun 2011
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercy Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaymeson Stroud, MD, Mercy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352598
- Sponsor's protocol ID
- 11-022
- Status last verified
- Sep 2020
- First submitted
- 10 May 2011
- Last updated
- 23 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer
- ClinicalTrials.gov ID
- NCT01352598
- Acronym / sponsor ID
- 11-022
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, stereotactic radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Mercy ResearchUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 12 May 2011 (estimated)
- Results
- Posted 23 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of organ confined prostate cancer.
Detailed description
This is a single site, non-randomized, prospective, phase IV trial of patients with organ-confined prostate cancer. Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues,tumor recurrence data, and acute and late toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiotherapy | Other | Radiation: stereotactic body radiotherapyPatients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient age >= 18 years
- Zubrod performance status of 0-3
- T1-3 N0 M0 adenocarcinoma of the prostate
- Prostate volume ≤ 100 cc
- Signed study-specific consent form
Key exclusion criteria (7 listed)
- Extension of local tumor to involve adjacent organs other than seminal vesicles (T4)
- Prostate volume > 100 cc
- Nodal involvement
- Metastatic disease
- Prior pelvic radiotherapy except as part of combination therapy for prostate cancer
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 body radiotherapyPatients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions. | Radiation | Stereotactic Body Radiotherapy |
Primary outcome
Biochemical Control Rate
Time frame: one year
Serial blood tests for prostate specific antigen (PSA) levels will be obtained at regular intervals (every 3 months).The "Phoenix definition" for biochemical recurrence (nadir + 2 ng/ml) will be used. Biochemical control rate will be expressed based on subjects experiencing tumor control (complete, partial, or stable) vs. subjects experiencing disease progression.
1 secondary outcome
Late Toxicity Rate
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stereotactic body radiotherapy in people with Prostate Cancer, run by Mercy Research 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 7 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: finished, as of the sponsor's last update on 23 Sep 2020. 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?
Yes. Results are posted in the registry (first posted 23 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Biochemical Control Rate (time frame: one year). 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 23 Sep 2020.