Prostate CancerPhase 2NCT00585962
Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate
A Phase 2 study testing Proton Beam Radiation in people with Prostate Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The primary purpose of this study is to determine if high doses of radiation using proton beam can be given safely with low and acceptable side effects. This study will also gather data to determine the ability of the proton beam to eradicate 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?
- Proton Beam Radiation
- Type of treatment
- Surgery or procedure
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Mar 2006
- 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
- Patients with previously treated adenocarcinoma of the stages T1c-T2b and Gleason of equal to or greater than 5.
- PSA values of equal to or less than 15 ng/ml must be demonstrated within two months prior to study entry and greater than 3 weeks after prostate biopsy.
- Zubrod status 0-1.
- No evidence of distant metastasis.
- No evidence of other cancer. Prior malignancy does not exclude the patient if disease free for greater than five years.
Who cannot join
- Clinical stages T2c or above.
- PSA greater than 15.
- Any patient with T1c disease, a PSA less than or equal to 4 and Gleason sum less than 6.
- Evidence of lymph node involvement if lymph node sampling performed.
- Previous prostate surgery to include: simple prostatectomy, TURP, hyperthermia and cryosurgery.
- Previous prostate radiation.
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- Prior hormonal therapy.
- History of inflammatory bowel disease even if currently inactive or controlled on medication.
- Prior systemic chemotherapy.
- History of proximal urethral stricture requiring dilatation.
- Current and continuing anticoagulation with Coumadin or equivalent.
- Major medical or psychiatric illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Phase II Study Using Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate
The primary purpose of this study is to determine if high doses of radiation using proton beam can be given safely with low and acceptable side effects. This study will also gather data to determine the ability of the proton beam to eradicate prostate cancer. Proton beam radiation is a very accurate kind of treatment that has been shown to affect less normal tissue than a regular radiation beam.
Read the detailed description
- Radiation therapy to the pelvis and prostate will be given once a day, 5 days a week (Monday-Friday), for 8 weeks. Each treatment takes about 10-20 minutes.
- Participants will be seen once a week for the entire 8 weeks by their study doctor to monitor and record any side effects. At the end of radiation therapy, participants will have a history and physical examination. Follow-up visits with the study doctor will be done at weeks 13 and 26 and then every 6 months for 3 years, then annually to year five.
- Conditions
- Prostate Cancer
- Being tested
- Proton Beam Radiation
- Keywords
- proton beam 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.
Proton Beam RadiationRadiation
Once a day, 5 days a week (Monday-Friday), for 8 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the late morbidity of 82 GY delivered to the prostate and surrounding tissues using proton beam radiation
Measured: 3 years
Secondary outcomes (1)
To assess the acute morbidity following protocol treatment and to determine the ability of this treatment to control cancer.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startFeb 2004
- Primary completionMar 2006
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.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Radiology Imaging Network
- Responsible party
- Principal investigator, Anthony Laurence Zietman, MD, Massachusetts General Hospital
- Investigators
- Anthony Zietman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585962
- Sponsor's protocol ID
- 02-064
- Status last verified
- Aug 2017
- First submitted
- 27 Dec 2007
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Using Proton Beam Radiation Therapy for Early Stage Adenocarcinoma of the Prostate
- ClinicalTrials.gov ID
- NCT00585962
- Acronym / sponsor ID
- 02-064
- Conditions
- Prostate Cancer
- Keywords
- proton beam radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American College of Radiology Imaging Network
- Study start
- Feb 2004
- Primary completion
- Mar 2006 (actual)
- First posted
- 4 Jan 2008 (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 primary purpose of this study is to determine if high doses of radiation using proton beam can be given safely with low and acceptable side effects. This study will also gather data to determine the ability of the proton beam to eradicate prostate cancer. Proton beam radiation is a very accurate kind of treatment that has been shown to affect less normal tissue than a regular radiation beam.
Detailed description
- Radiation therapy to the pelvis and prostate will be given once a day, 5 days a week (Monday-Friday), for 8 weeks. Each treatment takes about 10-20 minutes.
- Participants will be seen once a week for the entire 8 weeks by their study doctor to monitor and record any side effects. At the end of radiation therapy, participants will have a history and physical examination. Follow-up visits with the study doctor will be done at weeks 13 and 26 and then every 6 months for 3 years, then annually to year five.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
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)
- Patients with previously treated adenocarcinoma of the stages T1c-T2b and Gleason of equal to or greater than 5.
- PSA values of equal to or less than 15 ng/ml must be demonstrated within two months prior to study entry and greater than 3 weeks after prostate biopsy.
- Zubrod status 0-1.
- No evidence of distant metastasis.
- No evidence of other cancer. Prior malignancy does not exclude the patient if disease free for greater than five years.
Key exclusion criteria (12 listed)
- Clinical stages T2c or above.
- PSA greater than 15.
- Any patient with T1c disease, a PSA less than or equal to 4 and Gleason sum less than 6.
- Evidence of lymph node involvement if lymph node sampling performed.
- Previous prostate surgery to include: simple prostatectomy, TURP, hyperthermia and cryosurgery.
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 |
|---|---|---|
| Proton Beam RadiationOnce a day, 5 days a week (Monday-Friday), for 8 weeks. | Radiation | – |
Primary outcome
To assess the late morbidity of 82 GY delivered to the prostate and surrounding tissues using proton beam radiation
Time frame: 3 years
1 secondary outcome
To assess the acute morbidity following protocol treatment and to determine the ability of this treatment to control cancer.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 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.
Anthony Zietman, MD principal investigator
Massachusetts General Hospital
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 Proton Beam Radiation in people with Prostate Cancer, run by Massachusetts General Hospital 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 12 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 5 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the late morbidity of 82 GY delivered to the prostate and surrounding tissues using proton beam radiation (time frame: 3 years). 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 5 Sep 2017.