Prostate CancerNCT00703768
Quality of Life for Subjects Receiving Androgen Deprivation Therapy and Have a Doubling in PSA of Either Less Than or Greater Than 1 Year
An observational study of Prostate Cancer, run by Urology South Shore Research Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate if there is a difference in quality of life (as measured by FACT-P) in patients treated with androgen deprivation therapy (ADT) for biochemical failure (PSA recurrence) following surgery or radiation for prostate cancer depending on when ADT is initiated. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prostate Cancer
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2006to Jul 2010
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Male subjects aged 18 years or older with histologically-confirmed prostate cancer, showing biochemical failure (defined as a rising PSA) following definitive therapy (surgery or radiation) and indicated to receive hormone therapy.
Who may be able to join
- 18 years or older
- Received therapy of curative intent (surgery or radiotherapy)
- Have a rising PSA which has doubled from a nadir value.
- Histologically proven prostate cancer requiring androgen deprivation therapy for at least 12 months
- Written informed consent to participate in the trial.
Who cannot join
- Known hypersensitivity to Zoladex, Casodex, ar any component of these products
- Prior treatment with LHRH agonist or anti-androgens in the past 12 months
- Any concomitant condition that would make it undesirable, in the physician's opinion, for the subject to participate in the trial or would jeopardize compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Urology South Shore Research Inc.
Greenfield Park, Quebec, J4V 2H3
Lorne Aaron, MD, 450-671-2945, ussr@bellnet.ca
Carol Paris, 450-671-2945, ussr@bellnet.ca
About this study
Official title: An Open-Label, Phase ll Trial Comparing FACT-P Scores For Subjects Who Are Indicated To Receive Androgen Deprivation Therapy And Have A Doubling In PSA Post Curative Therapy Of Either Less Than Or Greater Than One Year
The purpose of this study is to evaluate if there is a difference in quality of life (as measured by FACT-P) in patients treated with androgen deprivation therapy (ADT) for biochemical failure (PSA recurrence) following surgery or radiation for prostate cancer depending on when ADT is initiated.
- Conditions
- Prostate Cancer
- Keywords
- Quality of Life, Androgen Deprivation Therapy, Goserelin
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Patients who have been identified as having a doubling in PSA from nadir of greater than one year | |
| B | Patients who have been identified as having a doubling in PSA from nadir of less than one year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant difference in FACT-P scores after 12 months between the 2 groups
Measured: 12 months
Secondary outcomes (3)
PSA response
Measured: 12 months
To evaluate the ease of use of FACT-P to measure Quality of Life
Measured: 12 months
QOL, side effect profile and evaluate the safety and tolerability of Androgen Deprivation Therapy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startJun 2006
- Primary completionJun 2010 (estimated)
- Study completionJul 2010 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Urology South Shore Research Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Investigators
- Lorne Aaron, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703768
- Sponsor's protocol ID
- D8664L00006
- Status last verified
- Feb 2009
- First submitted
- 19 Jun 2008
- Last updated
- 17 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase ll Trial Comparing FACT-P Scores For Subjects Who Are Indicated To Receive Androgen Deprivation Therapy And Have A Doubling In PSA Post Curative Therapy Of Either Less Than Or Greater Than One Year
- ClinicalTrials.gov ID
- NCT00703768
- Acronym / sponsor ID
- D8664L00006
- Conditions
- Prostate Cancer
- Keywords
- Quality of Life, Androgen Deprivation Therapy, Goserelin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Urology South Shore Research Inc.University, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jun 2006
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 23 Jun 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 purpose of this study is to evaluate if there is a difference in quality of life (as measured by FACT-P) in patients treated with androgen deprivation therapy (ADT) for biochemical failure (PSA recurrence) following surgery or radiation for prostate cancer depending on when ADT is initiated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | –Patients who have been identified as having a doubling in PSA from nadir of greater than one year |
| B | – | –Patients who have been identified as having a doubling in PSA from nadir of less than one year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male subjects aged 18 years or older with histologically-confirmed prostate cancer, showing biochemical failure (defined as a rising PSA) following definitive therapy (surgery or radiation) and indicated to receive hormone therapy.
Key inclusion criteria (5 listed)
- 18 years or older
- Received therapy of curative intent (surgery or radiotherapy)
- Have a rising PSA which has doubled from a nadir value.
- Histologically proven prostate cancer requiring androgen deprivation therapy for at least 12 months
- Written informed consent to participate in the trial.
Key exclusion criteria (3 listed)
- Known hypersensitivity to Zoladex, Casodex, ar any component of these products
- Prior treatment with LHRH agonist or anti-androgens in the past 12 months
- Any concomitant condition that would make it undesirable, in the physician's opinion, for the subject to participate in the trial or would jeopardize compliance with the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Significant difference in FACT-P scores after 12 months between the 2 groups
Time frame: 12 months
3 secondary outcomes
PSA response
Time frame: 12 months
To evaluate the ease of use of FACT-P to measure Quality of Life
Time frame: 12 months
QOL, side effect profile and evaluate the safety and tolerability of Androgen Deprivation Therapy
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2009.
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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.
Lorne Aaron, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Urology South Shore Research Inc. 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 5 inclusion and 3 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 17 Feb 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorne Aaron (450-671-2945, ussr@bellnet.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant difference in FACT-P scores after 12 months between the 2 groups (time frame: 12 months). 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 17 Feb 2009.