Prostatic NeoplasmsNCT00188708
Effect of Casodex on Tumour Hypoxia - Prostate Cancer
A study testing hypoxia measurement in people with Prostatic Neoplasms, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Prostate cancers, in common with many other tumours, are often hypoxic; that is, they have low levels of oxygen. It is thought that tumour hypoxia may hasten the progression of cancers and make them more resistant to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- hypoxia measurement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2001to 10 Mar 2022
- Phase
- Interventional
- 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
- Men with histologically proven prostatic carcinoma, stage cT2, N0, M0, receiving neoadjuvant bicalutamide plus conformal radiotherapy in study 9907, who have previously participated in the prostate cancer hypoxia project
- informed consent
Who cannot join
- Coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of the Effect of Neoadjuvant Bicalutamide (Casodex) on Tumour Hypoxia in Patients With Clinically Localized Prostate Cancer
Prostate cancers, in common with many other tumours, are often hypoxic; that is, they have low levels of oxygen. It is thought that tumour hypoxia may hasten the progression of cancers and make them more resistant to treatment. One previous study has suggested that hormone therapy, such as Casodex, may improve the prostate oxygen level. This study is designed to test that finding.
- Conditions
- Prostatic Neoplasms
- Being tested
- hypoxia measurement
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypoxia measurementProcedure or surgery
transrectal oxygen measurement
| Study group | Role | What they receive |
|---|---|---|
| hypoxia measurement | Experimental | Patients undergoing or planning to receive combined anti-androgen (Casodex) and radiotherapy Receives: Procedure: hypoxia measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of neoadjuvant anti-androgen therapy on oxygenation of prostatic tumours
Trans-rectal ultrasound and measurement of tumor oxygenation
Measured: 8 weeks
Correlate level of tumor oxygenation with PSA level
PSA test (ug/L)
Measured: 8 weeks
Correlate level of tumor oxygenation with hemoglobin level
hemoglobin test (g/L)
Measured: 8 weeks
Correlate level of tumor oxygenation with prostate volume
prostate volume measurement
Measured: 8 weeks
Secondary outcomes (1)
To study of the effect of neoadjuvant anti-androgen therapy on prostate tumour histopathology and gene expression, and correlation of these effects with changes in oxygenation.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startApr 2001
- Primary completion10 Mar 2022
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Trials Group, Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Michael Milosevic, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188708
- Sponsor's protocol ID
- UHN REB 00-0430-C
- Other IDs
- National Cancer Inst of Canada
- Status last verified
- Mar 2024
- First submitted
- 12 Sep 2005
- Last updated
- 18 Mar 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Effect of Neoadjuvant Bicalutamide (Casodex) on Tumour Hypoxia in Patients With Clinically Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT00188708
- Acronym / sponsor ID
- UHN REB 00-0430-C
- Conditions
- Prostatic Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Cancer Trials Group, Princess Margaret Hospital, Canada
- Study start
- Apr 2001
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 16 Sep 2005 (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.
Prostate cancers, in common with many other tumours, are often hypoxic; that is, they have low levels of oxygen. It is thought that tumour hypoxia may hasten the progression of cancers and make them more resistant to treatment. One previous study has suggested that hormone therapy, such as Casodex, may improve the prostate oxygen level. This study is designed to test that finding.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypoxia measurement | Experimental | Procedure: hypoxia measurementPatients undergoing or planning to receive combined anti-androgen (Casodex) and radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men with histologically proven prostatic carcinoma, stage cT2, N0, M0, receiving neoadjuvant bicalutamide plus conformal radiotherapy in study 9907, who have previously participated in the prostate cancer hypoxia project
- informed consent
Key exclusion criteria (1 listed)
- Coagulopathy
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 |
|---|---|---|
| hypoxia measurementtransrectal oxygen measurement | Procedure or surgery | hypoxia measurement |
Primary outcome
To determine the effect of neoadjuvant anti-androgen therapy on oxygenation of prostatic tumours
Time frame: 8 weeks
Trans-rectal ultrasound and measurement of tumor oxygenation
Correlate level of tumor oxygenation with PSA level
Time frame: 8 weeks
PSA test (ug/L)
Correlate level of tumor oxygenation with hemoglobin level
Time frame: 8 weeks
hemoglobin test (g/L)
Correlate level of tumor oxygenation with prostate volume
Time frame: 8 weeks
prostate volume measurement
1 secondary outcome
To study of the effect of neoadjuvant anti-androgen therapy on prostate tumour histopathology and gene expression, and correlation of these effects with changes in oxygenation.
Time frame: 8 weeks
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 18 Mar 2024.
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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.
Michael Milosevic, MD principal investigator
Princess Margaret Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypoxia measurement in people with Prostatic Neoplasms, run by University Health Network, Toronto 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 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 18 Mar 2024. 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.
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 determine the effect of neoadjuvant anti-androgen therapy on oxygenation of prostatic tumours (time frame: 8 weeks). The study lists 4 primary outcomes in all. 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 18 Mar 2024.