Prostate CancerPhase 3NCT00548600
Radical Radiotherapy by External Beam Radiation Versus Radical Radiotherapy With Temporary Iridium Implant Plus External Beam Radiation in Carcinoma of the Prostate
A Phase 3 study testing Iridium Implant and Standard external beam irradiation in people with Prostate Cancer, run by Ontario Clinical Oncology Group (OCOG) at 1 site in Canada.
Trial summary
The specific objective of this study is to compare the relative efficacy of the combination of a temporary iridium implant plus external beam irradiation versus standard external beam irradiation alone in patients with Stage B2 and C prostatic carcinoma. Read more about this study
- Who is it for?
- Ages Up to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Iridium Implant and Standard external beam irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteCanada
- Study dates
- May 1992to Sep 2006
- 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 Up to 75 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients must have histologically proven adenocarcinoma of the prostate
- The primary tumour should be staged clinically B2 or C as classified by A.J.C. Staging System
Who cannot join
- Patients requiring transurethral prostatectomy (TURP) prior to diagnosis
- Presence of metastases identified by bone scan, chest x-ray or CT scan of the abdomen and pelvis, or staging lymphadenectomy
- Karnofsky performance status less than 80
- Inadequate laboratory results: i.e. Hb < 12 gm/litre, WBC < 3.5 x 10 per litre, platelets < 100 x 10/litre, urea > 13 mmol/litre, creatinine > 220 mmol/litre
- Unfit for surgery for other medical reasons
- Age above 75 years
- Failure to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial Comparing Radical Radiotherapy by External Beam Radiation Versus Radical Radiotherapy Using a Combination of a Temporaory Iridium Implant Plus External Beam Radiation in Surgically Staged B2 and C Carcinoma of the Prostate
The specific objective of this study is to compare the relative efficacy of the combination of a temporary iridium implant plus external beam irradiation versus standard external beam irradiation alone in patients with Stage B2 and C prostatic carcinoma. Benefit will be assessed in terms of local recurrence, survival, and toxicity.
- Conditions
- Prostate Cancer
- Being tested
- Iridium Implant, Standard external beam irradiation
- Keywords
- Prostate Cancer, Iridium, Implant, 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.
Iridium ImplantProcedure or surgery
Temporary iridium implant of the prostate will be done and a dose of 3000 cGy will be delivered in the next 48-72 hours. Two weeks later 20 fractions of external beam radiation at a dose of 4000 cGy will be administered over a period of 4 weeks.
Standard external beam irradiationRadiation
Standard external beam irradiation at a dose of 6400 cGy in 32 fractions over 6 and a half weeks will be administered.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Iridium implant plus external beam irradiation Receives: Procedure: Iridium Implant |
| 2 | Active comparator | Standard external beam irradiation alone Receives: Radiation: Standard external beam irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of local control as determined by biopsy at 18 months
Measured: 18-months
Secondary outcomes (4)
Distant metastasis
Measured: survival
Overall mortality
Measured: survival
Mortality due to prostate cancer
Measured: survival
Local complications of radiation
Measured: 2-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2007 (estimated)
- Study startMay 1992
- Study completionSep 2006
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
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Investigators
- Jinka Sathya, MD, Study chair, Juravinski Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548600
- Sponsor's protocol ID
- OCOG-1992-Iridium
- Status last verified
- Oct 2007
- First submitted
- 22 Oct 2007
- Last updated
- 24 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Sathya JR, Davis IR, Julian JA, Guo Q, Daya D, Dayes IS, Lukka HR, Levine M. Randomized trial comparing iridium implant plus external-beam radiation therapy with external-beam radiation therapy alone in node-negative locally advanced cancer of the prostate. J Clin Oncol. 2005 Feb 20;23(6):1192-9. doi: 10.1200/JCO.2005.06.154.
PubMed 15718316
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing Radical Radiotherapy by External Beam Radiation Versus Radical Radiotherapy Using a Combination of a Temporaory Iridium Implant Plus External Beam Radiation in Surgically Staged B2 and C Carcinoma of the Prostate
- ClinicalTrials.gov ID
- NCT00548600
- Acronym / sponsor ID
- OCOG-1992-Iridium
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Iridium, Implant, Radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Study start
- May 1992
- Study completion
- Sep 2006 (actual)
- First posted
- 24 Oct 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.
The specific objective of this study is to compare the relative efficacy of the combination of a temporary iridium implant plus external beam irradiation versus standard external beam irradiation alone in patients with Stage B2 and C prostatic carcinoma. Benefit will be assessed in terms of local recurrence, survival, and toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Iridium ImplantIridium implant plus external beam irradiation |
| 2 | Active comparator | Radiation: Standard external beam irradiationStandard external beam irradiation alone |
Who may qualify
- Ages
- Up to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All patients must have histologically proven adenocarcinoma of the prostate
- The primary tumour should be staged clinically B2 or C as classified by A.J.C. Staging System
Key exclusion criteria (7 listed)
- Patients requiring transurethral prostatectomy (TURP) prior to diagnosis
- Presence of metastases identified by bone scan, chest x-ray or CT scan of the abdomen and pelvis, or staging lymphadenectomy
- Karnofsky performance status less than 80
- Inadequate laboratory results: i.e. Hb < 12 gm/litre, WBC < 3.5 x 10 per litre, platelets < 100 x 10/litre, urea > 13 mmol/litre, creatinine > 220 mmol/litre
- Unfit for surgery for other medical reasons
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 |
|---|---|---|
| Iridium ImplantTemporary iridium implant of the prostate will be done and a dose of 3000 cGy will be delivered in the next 48-72 hours. Two weeks later 20 fractions of external beam radiation at a dose of 4000 cGy will be administered over a period of 4 weeks. | Procedure or surgery | 1 |
| Standard external beam irradiationStandard external beam irradiation at a dose of 6400 cGy in 32 fractions over 6 and a half weeks will be administered. | Radiation | 2 |
Primary outcome
Rate of local control as determined by biopsy at 18 months
Time frame: 18-months
4 secondary outcomes
Distant metastasis
Time frame: survival
Overall mortality
Time frame: survival
Mortality due to prostate cancer
Time frame: survival
Local complications of radiation
Time frame: 2-5 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 24 Oct 2007.
- Background: PubMed 15718316Sathya JR, Davis IR, Julian JA, Guo Q, Daya D, Dayes IS, Lukka HR, Levine M. Randomized trial comparing iridium implant plus external-beam radiation therapy with external-beam radiation therapy alone in node-negative locally advanced cancer of the prostate. J Clin Oncol. 2005 Feb 20;23(6):1192-9. doi: 10.1200/JCO.2005.06.154.
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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.
Jinka Sathya, MD study chair
Juravinski Cancer Centre
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 Iridium Implant and Standard external beam irradiation in people with Prostate Cancer, run by Ontario Clinical Oncology Group (OCOG) at 1 site in Canada.
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 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 24 Oct 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 Canada. 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?
Rate of local control as determined by biopsy at 18 months (time frame: 18-months). 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 NCT00548600, 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 24 Oct 2007.