Prostatic NeoplasmNCT01540994
Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer
A study testing Radiation Therapy in people with Prostatic Neoplasm, run by Sharp HealthCare at 1 site in United States.
Trial summary
The purpose of this study is to evaluate a short course (five radiation treatments) of very focused ("stereotactic") external beam radiation therapy for the treatment of early stage prostate cancer. Read more about this study
- Who is it for?
- Ages 50 to 90 years, men only
- Conditions the study is for
- Prostatic Neoplasm
- What is being tested?
- Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to 5 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 50 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male with any age (typically 50 to 70 years old) with a low risk disease. This is defined as a Gleason's score of 6 or less, clinical stage of T2a or less, and a PSA of less than 15. We will also include patients with Gleason's score of 3+4=7 if there are fewer than 2 cores positive, with no more than 5mm of tumor in aggregate dimension.
Who cannot join
- Prior surgery or radiotherapy for prostate cancer, PSA over 10, Gleason scores 7, 8, 9, or 10 (except Gleason 7 as noted, above), or clinical stage T2b, T2c, T3, or T4.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sharp Memorial Hospital
San Diego, California, 92123
About this study
Official title: Phase I/II Trial of Stereotactic Hypofractionated Radiotherapy of the Prostate
The purpose of this study is to evaluate a short course (five radiation treatments) of very focused ("stereotactic") external beam radiation therapy for the treatment of early stage prostate cancer.
Read the detailed description
External beam radiation therapy for prostate cancer, while effective, takes up to 9 weeks to deliver on a Monday through Friday basis. Recent phase I/II studies from Seattle and Palo Alto using stereotactic guidance to deliver high doses of radiation to the prostate over a 1 to 2 week period of time suggest that outcomes may be equal or superior to standard approaches. These data, combined with markedly improved convenience for patients, make radiosurgery (SBRT) for early-stage prostate cancer an enticing option. The goal of this study is to offer a radiosurgical option to patients within the Sharp system under the umbrella of an IRB-approved study.
- Conditions
- Prostatic Neoplasm
- Being tested
- Radiation Therapy
- Keywords
- Neoplasms, Urogenital neoplasm, Genital neoplasms, male
- Medical subject headings
- Prostatic Neoplasms, Neoplasms, Urogenital Neoplasms, Genital Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
Stereotactic Body Radiation Therapy
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiation Therapy | Experimental | Stereotactic Body Radiation Therapy Receives: Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales.
Acute and late genitourinary and lower gastrointestinal toxicity will be evaluated using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales, which range from 0-5, where a high score corresponds to a worse outcome/worse toxicity. Toxicity will be measured weekly during radiation, and every 6-12 months following radiation through patient interview. The acute toxicity score will be defined as the highest score obtained from measurements taken during radiation for each participant. The late toxicity score will be defined as the highest score obtained from measurements taken following completion of radiation for each participant.
Measured: Assessed weekly during radiation (from day 1 up to 3 weeks) for acute toxicity, and every 6-12 months following completion of radiation (from 3 weeks up to 84 months) for late toxicity.
Secondary outcomes (1)
Rate of Biochemical Disease-free Status
Patients will be followed after completion of treatment with PSA tests every 6-12 months Patients will be deemed to have "biochemical failure" if the post-treatment PSA increases by 2 ng/ml or more above the post-radiation nadir PSA. Patients who do not qualify as having "biochemical failure" will be deemed as "biochemically disease-free".
Measured: mean 41 months (range 3-84 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startJan 2011
- Primary completion5 Apr 2019
- Study completion5 Apr 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 Prostatic NeoplasmStudies 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
- Model description
- Radiotherapy: phase 1/2 (but no drug, biological/vaccine or combination product used)
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geoffrey Weinstein, M.D., Sharp HealthCare
- Investigators
- Geoffrey Weinstein, M.D., Principal investigator, Sharp HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540994
- Sponsor's protocol ID
- 101091
- Status last verified
- Jan 2025
- First submitted
- 23 Feb 2012
- Last updated
- 16 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of Stereotactic Hypofractionated Radiotherapy of the Prostate
- ClinicalTrials.gov ID
- NCT01540994
- Acronym / sponsor ID
- 101091
- Conditions
- Prostatic Neoplasm
- Keywords
- Neoplasms, Urogenital neoplasm, Genital neoplasms, male
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 29 Feb 2012 (estimated)
- Results
- Posted 16 Jan 2025
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 evaluate a short course (five radiation treatments) of very focused ("stereotactic") external beam radiation therapy for the treatment of early stage prostate cancer.
Detailed description
External beam radiation therapy for prostate cancer, while effective, takes up to 9 weeks to deliver on a Monday through Friday basis. Recent phase I/II studies from Seattle and Palo Alto using stereotactic guidance to deliver high doses of radiation to the prostate over a 1 to 2 week period of time suggest that outcomes may be equal or superior to standard approaches. These data, combined with markedly improved convenience for patients, make radiosurgery (SBRT) for early-stage prostate cancer an enticing option. The goal of this study is to offer a radiosurgical option to patients within the Sharp system under the umbrella of an IRB-approved study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Radiotherapy: phase 1/2 (but no drug, biological/vaccine or combination product used)
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiation Therapy | Experimental | Radiation: Radiation TherapyStereotactic Body Radiation Therapy |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male with any age (typically 50 to 70 years old) with a low risk disease. This is defined as a Gleason's score of 6 or less, clinical stage of T2a or less, and a PSA of less than 15. We will also include patients with Gleason's score of 3+4=7 if there are fewer than 2 cores positive, with no more than 5mm of tumor in aggregate dimension.
Key exclusion criteria (1 listed)
- Prior surgery or radiotherapy for prostate cancer, PSA over 10, Gleason scores 7, 8, 9, or 10 (except Gleason 7 as noted, above), or clinical stage T2b, T2c, T3, or T4.
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 |
|---|---|---|
| Radiation TherapyStereotactic Body Radiation Therapy | Radiation | Stereotactic Body Radiation Therapy |
Primary outcome
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales.
Time frame: Assessed weekly during radiation (from day 1 up to 3 weeks) for acute toxicity, and every 6-12 months following completion of radiation (from 3 weeks up to 84 months) for late toxicity.
Acute and late genitourinary and lower gastrointestinal toxicity will be evaluated using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales, which range from 0-5, where a high score corresponds to a worse outcome/worse toxicity. Toxicity will be measured weekly during radiation, and every 6-12 months following radiation through patient interview. The acute toxicity score will be defined as the highest score obtained from measurements taken during radiation for each participant. The late toxicity score will be defined as the highest score obtained from measurements taken following completion of radiation for each participant.
1 secondary outcome
Rate of Biochemical Disease-free Status
Time frame: mean 41 months (range 3-84 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- 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.
Geoffrey Weinstein, M.D. principal investigator
Sharp HealthCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation Therapy in people with Prostatic Neoplasm, run by Sharp HealthCare 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 1 inclusion and 1 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 16 Jan 2025. 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 16 Jan 2025). 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?
Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales. (time frame: Assessed weekly during radiation (from day 1 up to 3 weeks) for acute toxicity, and every 6-12 months following completion of radiation (from 3 weeks up to 84 months) for late toxicity.). 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 16 Jan 2025.