Prostate CancerPhase 3NCT00486499
I-125 Versus Pd-103 for Medium Risk Prostate Cancer
A Phase 3 study testing I-125 versus Pd-103 radioactive seed insertion in people with Prostate Cancer, run by VA Puget Sound Health Care System at 2 sites in United States.
Trial summary
hypothesis: the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication. A total of 660 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 7 to 9 and/or PSA 10-20 ng/ml) will be randomized to implantation with I-125 (144 Gy) versus Pd-103 (124 Gy). Read more about this study
- Who is it for?
- Ages 40 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- I-125 versus Pd-103 radioactive seed insertion
- Type of treatment
- Surgery or procedure
- How many people
- 660 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2003to not given
- 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 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PSA 4-10 ng/ml
- Gleason score 5 or 6
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Group Health Cooperative
Seattle, Washington, 98104
Kent E Wallner, MD, 206-326-3490, kent.wallner@med.va.gov
Kent E Wallner, MD
- Recruiting
VA Puget Sound
Seattle, Washington, 98108
Kent E Wallner, MD, 206-768-5356, kent.wallner@med.va.gov
Kent E Wallner, MD
About this study
hypothesis: the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication.
A total of 660 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 7 to 9 and/or PSA 10-20 ng/ml) will be randomized to implantation with I-125 (144 Gy) versus Pd-103 (124 Gy).
Read the detailed description
Objective: The objective of this study is test the hypothesis that the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication.
Research plan:
A total of 660 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 7 to 9 and/or PSA 10-20 ng/ml) will be randomized to implantation with I-125 (144 Gy) versus Pd-103 (124 Gy).
Methodology:
Randomization will be accomplished by the method of random permuted blocks.
Cancer status will be monitored by yearly serial serum PSA. 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.
Primary endpoint: Time to treatment failure. Patients with serum PSA above 0.5 ng/ml two years or more after treatment will be considered to have residual or recurrent cancer and to have failed therapy.
- Conditions
- Prostate Cancer
- Being tested
- I-125 versus Pd-103 radioactive seed insertion
- Keywords
- radiation, brachytherapy, prostate, cancer
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-125 versus Pd-103 radioactive seed insertionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA-based cancer eradication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2007 (estimated)
- Study startMar 2003
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Puget Sound Health Care System
- Sponsor type
- US federal agency
- Collaborators
- Dr. Gregory Merrick, Theragenics Corporation
- Investigators
- Kent E Wallner, MD, Principal investigator, VA Puget Sound, Group Health Cooperative, U of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486499
- Sponsor's protocol ID
- 02-4407-V04
- Status last verified
- Jun 2007
- First submitted
- 12 Jun 2007
- Last updated
- 14 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-125 Versus Pd-103 for Medium Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT00486499
- Acronym / sponsor ID
- 02-4407-V04
- Conditions
- Prostate Cancer
- Keywords
- radiation, brachytherapy, prostate, cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- VA Puget Sound Health Care SystemUS federal agency
- Collaborators
- Dr. Gregory Merrick, Theragenics Corporation
- Study start
- Mar 2003
- First posted
- 14 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.
hypothesis: the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication.
A total of 660 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 7 to 9 and/or PSA 10-20 ng/ml) will be randomized to implantation with I-125 (144 Gy) versus Pd-103 (124 Gy).
Detailed description
Objective: The objective of this study is test the hypothesis that the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication.
Research plan:
A total of 660 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 7 to 9 and/or PSA 10-20 ng/ml) will be randomized to implantation with I-125 (144 Gy) versus Pd-103 (124 Gy).
Methodology:
Randomization will be accomplished by the method of random permuted blocks.
Cancer status will be monitored by yearly serial serum PSA. 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.
Primary endpoint: Time to treatment failure. Patients with serum PSA above 0.5 ng/ml two years or more after treatment will be considered to have residual or recurrent cancer and to have failed therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- PSA 4-10 ng/ml
- Gleason score 5 or 6
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| I-125 versus Pd-103 radioactive seed insertion | Procedure or surgery | – |
Primary outcome
PSA-based cancer eradication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2007.
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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 principal investigator
VA Puget Sound, Group Health Cooperative, U of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing I-125 versus Pd-103 radioactive seed insertion in people with Prostate Cancer, run by VA Puget Sound Health Care System at 2 sites 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 2 inclusion and 0 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 14 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 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact kent E Wallner, md (206-768-5356, kent.wallner@med.va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA-based cancer eradication. 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 14 Jun 2007; AzTrials last refreshed its copy on 6 Nov 2026.