Prostate CancerPhase 4COMARTNCT00590213
Compare the Value of Prophylactic Versus Therapeutic Breast Radiotherapy in CASODEX
A Phase 4 study testing Casodex 150mg, Radiotherapy and Haematology in people with Prostate Cancer, run by AstraZeneca at 9 sites in Turkey (Türkiye).
Trial summary
The primary objective of this trial is to examine the value of prophylactic versus therapeutic breast radiotherapy in Casodex monotherapy induced gynaecomastia and/or breast pain. 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?
- Casodex 150mg, Radiotherapy and Haematology
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- 9 sitesTurkey (Türkiye)
- Study dates
- Jun 2003to not given
- Phase
- Phase 4
- 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
- Males patients aged 18 years or over on entry into the trial
- Patients who have non-metastatic cancer that is confirmed by histology or cytology. This primary treatment should have been completed in the last 8 weeks
- The stage should be T1b/T1c/T2/T3/T4 any N category
- Paitents must have given written, fully informed consent to participate in the trial prior to any trial specific assessments being made
- Be able and prepared to comply with trial procedures and restrictions
- Have a life expectancy greater than 2 years
Who cannot join
- Any known sensitivity to radiation therapy or any conditions which in the investigator's opinion may lead to radiation sensitivity
- Patients with any concurrent malignancy (except for basal cell or TO-2 NO MO squamous cell carcinoma of the skin). History of previous malignancy or treatment for any cancer in the past 5 years
- Previous history of mastectomy including a Webster operation or radiation therapy to the chest area
- Any previous treatment with surgical or medical castration, anti-androgens, monotherapy or oestrogen therapy at any time
- Any evidence of pre-existing gynaecomastia or breast pain
- Patients with history or presence of testicular abnormalities (as CASODEX can potentially aggravate testicular tumours)
Show all 13Show fewer
- Patients with any concurrent disease or condition that in the opinion of the treating physician, would constitute a hazard for participation in this study or may interfere with the patient's ability to comply with the scheduled visits and assessments. This includes patients whose physical build would prevent reasonable assessment of gynaecomastia
- Liver disease (bilirubin greater than 2.0mg/dL; AST/ALT greater than 2 times the upper limit or normal)
- Patients taking the following drugs; terfenadine, cisapride, astemizole, cyclosporin, and warfarin are excluded from the trial due to the possibility of drug interaction
- Patients with a known history of alcohol abuse
- Concurrent treatment with any druges known to have high potential for causing gynaecomastia or breast pain, eg.Spironolactone, steroid therapy, cimetidine and neuroleptic agents.
- Treatment with a new chemical entity within the previous 4 months or current participation in another clinical trial involving an investigational product
- Patients considered by the investigator to be at risk of transmitting any infection through the body or other body fluids, including acquired immue dificiency syndrome (AIDS) other sexually transmitted diseases or hepatitis
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Turkey (Türkiye)9 sites
Research Site
Adana
Research Site
Ankara
Research Site
Diyarbak?r
Research Site
Edirne
Research Site
Eskişehir
Research Site
Istanbul
Research Site
Izmir
Research Site
Manisa
Research Site
Samsun
About this study
Official title: An Open Randomised Trial to Compare the Value of Prophylactic Versus Therapeutic Breast Radiotherapy in CASODEX Monotherapy Induced Gynaecomastia and/or Breast Pain in Prostate Cancer Patients
The primary objective of this trial is to examine the value of prophylactic versus therapeutic breast radiotherapy in Casodex monotherapy induced gynaecomastia and/or breast pain. Patients will receive either prophylactic radiotherapy to the breast at a dose of 12Gy (as two fractions of 6 Gy in consecutives days), or will not receive any radiotherapy prior to commencing CASODEX 150mg monotherapy.
- Conditions
- Prostate Cancer
- Being tested
- Casodex 150mg, Radiotherapy, Haematology
- Keywords
- Casodex, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Casodex 150mgDrug
RadiotherapyProcedure or surgery
HaematologyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the value of prophylactic versus therapeutic breast radiotherapy in Casodex monotherapy induced gynaecomastia and/or breast pain
Secondary outcomes (3)
To examine the tolerability of radiotherapy to male breast
To examine the tolerability of Casodex 150mg in localized and locally advanced prostate cancer patients
To examine the efficacy of Casodex 150mg in prostate cancer patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startJun 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.
- More trials run by AstraZenecaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Haluk Ozen, Prof, Principal investigator, Hacettepe Univ. Med. Fac
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590213
- Sponsor's protocol ID
- 7054TR/01
- Acronym
- COMART
- Status last verified
- Jan 2008
- First submitted
- 28 Dec 2007
- Last updated
- 25 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Randomised Trial to Compare the Value of Prophylactic Versus Therapeutic Breast Radiotherapy in CASODEX Monotherapy Induced Gynaecomastia and/or Breast Pain in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT00590213
- Acronym / sponsor ID
- COMART / 7054TR/01
- Conditions
- Prostate Cancer
- Keywords
- Casodex, Prostate Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- First posted
- 10 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 objective of this trial is to examine the value of prophylactic versus therapeutic breast radiotherapy in Casodex monotherapy induced gynaecomastia and/or breast pain. Patients will receive either prophylactic radiotherapy to the breast at a dose of 12Gy (as two fractions of 6 Gy in consecutives days), or will not receive any radiotherapy prior to commencing CASODEX 150mg monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (6 listed)
- Males patients aged 18 years or over on entry into the trial
- Patients who have non-metastatic cancer that is confirmed by histology or cytology. This primary treatment should have been completed in the last 8 weeks
- The stage should be T1b/T1c/T2/T3/T4 any N category
- Paitents must have given written, fully informed consent to participate in the trial prior to any trial specific assessments being made
- Be able and prepared to comply with trial procedures and restrictions
Key exclusion criteria (13 listed)
- Any known sensitivity to radiation therapy or any conditions which in the investigator's opinion may lead to radiation sensitivity
- Patients with any concurrent malignancy (except for basal cell or TO-2 NO MO squamous cell carcinoma of the skin). History of previous malignancy or treatment for any cancer in the past 5 years
- Previous history of mastectomy including a Webster operation or radiation therapy to the chest area
- Any previous treatment with surgical or medical castration, anti-androgens, monotherapy or oestrogen therapy at any time
- Any evidence of pre-existing gynaecomastia or breast pain
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 |
|---|---|---|
| Casodex 150mg | Drug | – |
| Radiotherapy | Procedure or surgery | – |
| Haematology | Procedure or surgery | – |
Primary outcome
To examine the value of prophylactic versus therapeutic breast radiotherapy in Casodex monotherapy induced gynaecomastia and/or breast pain
3 secondary outcomes
To examine the tolerability of radiotherapy to male breast
To examine the tolerability of Casodex 150mg in localized and locally advanced prostate cancer patients
To examine the efficacy of Casodex 150mg in prostate cancer patients
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 25 Jan 2008.
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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.
Haluk Ozen, Prof principal investigator
Hacettepe Univ. Med. Fac
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Casodex 150mg, Radiotherapy and Haematology in people with Prostate Cancer, run by AstraZeneca at 9 sites in Turkey (Türkiye).
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 6 inclusion and 13 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 25 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 examine the value of prophylactic versus therapeutic breast radiotherapy in Casodex monotherapy induced gynaecomastia and/or breast pain. 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 25 Jan 2008.