Prostate CancerPhase 3NCT00494546
High Versus Low Dose Supplemental External Radiation With Pd-103 for Prostate Cancer
A Phase 3 study testing Pd-103 with 20 vs 44 Gy supplemental beam XRT in people with Prostate Cancer, run by VA Puget Sound Health Care System at 1 site in United States.
Trial summary
Objective: The objective of this study is test the hypothesis that delivering a higher percentage of the radiation dose as external radiation versus implant will lead to higher tumor control rates. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Pd-103 with 20 vs 44 Gy supplemental beam XRT
- Type of treatment
- Surgery or procedure
- How many people
- 568 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1999to Jun 2007
- Phase
- Phase 3
- 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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males
- Prostate cancer
- PSA 10-20
- Gleason score 7-10
Who cannot join
- Lymph nodes positive
Trial locations and contacts
1 site in 1 country.
About this study
Objective: The objective of this study is test the hypothesis that delivering a higher percentage of the radiation dose as external radiation versus implant will lead to higher tumor control rates.
Research design A total of 600 patients with AJC clinical stage T1-T2 prostatic carcinoma (Gleason grade 7 to 10 and/or PSA 10 to 20 ng/ml) will be randomized to treatment with 44 Gy versus 20 Gy external radiation plus a Pd-103 implant boost (90 Gy versus 105 Gy, respectively).
Read the detailed description
Objective: The objective of this study is test the hypothesis that delivering a higher percentage of the radiation dose as external radiation versus implant will lead to higher tumor control rates.
Research design A total of 600 patients with AJC clinical stage T1-T2 prostatic carcinoma (Gleason grade 7 to 10 and/or PSA 10 to 20 ng/ml) will be randomized to treatment with 44 Gy versus 20 Gy external radiation plus a Pd-103 implant boost (90 Gy versus 105 Gy, respectively).
Methodology: Patients will be randomized by the method of random permuted blocks.
Cancer status will be monitored by serial serum PSA at 6, 12, 18 and 24 months and yearly thereafter. Treatment-related morbidity will be monitored by personal interview, using standard American Urologic Association and Radiation Therapy Oncology Group criteria at 1, 3, 6, 12 and 24 months. The primary endpoint will be based on serum PSA. A value above 1.0 ng/ml two years after treatment will be considered to have residual or recurrent cancer and to have failed therapy.
Findings: 566 patients have been randomized and the study was closed due to slowing accrual. A preliminary analysis shows similar morbidity between the treatment arms, and nearly identical cancer control rates between randomization arms.
- Conditions
- Prostate Cancer
- Being tested
- Pd-103 with 20 vs 44 Gy supplemental beam XRT
- Keywords
- prostate, brachytherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pd-103 with 20 vs 44 Gy supplemental beam XRTProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
cancer control
Measured: 5-year post treatment
Secondary outcomes (1)
rectal and urinary morbidity
Measured: 2- and 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2007 (estimated)
- Study startJan 1999
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 568 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Puget Sound Health Care System
- Sponsor type
- US federal agency
- Collaborators
- Schiffler Cancer Center
- Investigators
- Kent E Wallner, MD, Study chair, Puget Sound Health Care system
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494546
- Sponsor's protocol ID
- 2044
- Status last verified
- Jun 2007
- First submitted
- 28 Jun 2007
- Last updated
- 29 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Wallner K, Merrick G, True L, Sherertz T, Sutlief S, Cavanagh W, Butler W. 20 Gy versus 44 Gy supplemental beam radiation with Pd-103 prostate brachytherapy: preliminary biochemical outcomes from a prospective randomized multi-center trial. Radiother Oncol. 2005 Jun;75(3):307-10. doi: 10.1016/j.radonc.2005.03.019.
PubMed 16086912
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Versus Low Dose Supplemental External Radiation With Pd-103 for Prostate Cancer
- ClinicalTrials.gov ID
- NCT00494546
- Acronym / sponsor ID
- 2044
- Conditions
- Prostate Cancer
- Keywords
- prostate, brachytherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 568 participants (actual)
- Lead sponsor
- VA Puget Sound Health Care SystemUS federal agency
- Collaborators
- Schiffler Cancer Center
- Study start
- Jan 1999
- Study completion
- Jun 2007 (actual)
- First posted
- 29 Jun 2007 (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.
Objective: The objective of this study is test the hypothesis that delivering a higher percentage of the radiation dose as external radiation versus implant will lead to higher tumor control rates.
Research design A total of 600 patients with AJC clinical stage T1-T2 prostatic carcinoma (Gleason grade 7 to 10 and/or PSA 10 to 20 ng/ml) will be randomized to treatment with 44 Gy versus 20 Gy external radiation plus a Pd-103 implant boost (90 Gy versus 105 Gy, respectively).
Detailed description
Objective: The objective of this study is test the hypothesis that delivering a higher percentage of the radiation dose as external radiation versus implant will lead to higher tumor control rates.
Research design A total of 600 patients with AJC clinical stage T1-T2 prostatic carcinoma (Gleason grade 7 to 10 and/or PSA 10 to 20 ng/ml) will be randomized to treatment with 44 Gy versus 20 Gy external radiation plus a Pd-103 implant boost (90 Gy versus 105 Gy, respectively).
Methodology: Patients will be randomized by the method of random permuted blocks.
Cancer status will be monitored by serial serum PSA at 6, 12, 18 and 24 months and yearly thereafter. Treatment-related morbidity will be monitored by personal interview, using standard American Urologic Association and Radiation Therapy Oncology Group criteria at 1, 3, 6, 12 and 24 months. The primary endpoint will be based on serum PSA. A value above 1.0 ng/ml two years after treatment will be considered to have residual or recurrent cancer and to have failed therapy.
Findings: 566 patients have been randomized and the study was closed due to slowing accrual. A preliminary analysis shows similar morbidity between the treatment arms, and nearly identical cancer control rates between randomization arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males
- Prostate cancer
- PSA 10-20
- Gleason score 7-10
Key exclusion criteria (1 listed)
- Lymph nodes positive
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 |
|---|---|---|
| Pd-103 with 20 vs 44 Gy supplemental beam XRT | Procedure or surgery | – |
Primary outcome
cancer control
Time frame: 5-year post treatment
1 secondary outcome
rectal and urinary morbidity
Time frame: 2- and 5-year
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 29 Jun 2007.
- Results publication: PubMed 16086912Wallner K, Merrick G, True L, Sherertz T, Sutlief S, Cavanagh W, Butler W. 20 Gy versus 44 Gy supplemental beam radiation with Pd-103 prostate brachytherapy: preliminary biochemical outcomes from a prospective randomized multi-center trial. Radiother Oncol. 2005 Jun;75(3):307-10. doi: 10.1016/j.radonc.2005.03.019.
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RecruitingPhase 3
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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.
Kent E Wallner, MD study chair
Puget Sound Health Care system
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pd-103 with 20 vs 44 Gy supplemental beam XRT in people with Prostate Cancer, run by VA Puget Sound Health Care System 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 4 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 29 Jun 2007. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
cancer control (time frame: 5-year post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00494546, which also lists 1 linked publication.
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 29 Jun 2007.