Prostate CancerNCT00052481
Quality of Life in Patients Undergoing Surgery or Brachytherapy for Stage II Prostate Cancer
An observational study of Prostate Cancer, run by Alliance for Clinical Trials in Oncology at 13 sites in United States.
Trial summary
RATIONALE: Quality of life assessment in patients undergoing prostate cancer treatment may help determine the intermediate-term and long-term effects of surgery and brachytherapy. 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?
- quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 13 sitesUnited States
- Study dates
- Sep 2002to Apr 2004
- 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 Up to 75 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with adenocarcinoma of the prostate and previously enrolled on ACOSOG-Z0070.
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate within the past 120 days
- Stage II disease (T1c-T2a, N0, M0)
- Concurrent enrollment on ACOSOG-Z0070
- Not yet randomized to an intervention arm (radical prostatectomy or brachytherapy)
- Willing and able to complete heath-related quality of life questionnaires
PATIENT CHARACTERISTICS:
Age
- 75 and under
PRIOR CONCURRENT THERAPY:
Endocrine therapy
- More than 6 months since prior hormonal therapy for prostate cancer
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, 05401
Presbyterian Hospital
Charlotte, North Carolina, 28233-3549
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1062
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
UCSF Comprehensive Cancer Center
San Francisco, California, 94143-0128
University Cancer Center at University of Washington Medical Center
Seattle, Washington, 98195-6043
Washington University School of Medicine
St Louis, Missouri, 63110
Madigan Army Medical Center
Tacoma, Washington, 98431-5048
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
About this study
Official title: Health-Related Quality Of Life In Patients With Low Risk, Localized Prostate Cancer Randomized To Radical Prostatectomy Or Brachytherapy
RATIONALE: Quality of life assessment in patients undergoing prostate cancer treatment may help determine the intermediate-term and long-term effects of surgery and brachytherapy.
PURPOSE: Randomized clinical trial to study quality of life in patients undergoing radical prostatectomy or brachytherapy for stage II prostate cancer.
Read the detailed description
OBJECTIVES:
- Compare changes in health-related quality of life (HRQOL) in patients with stage II prostate cancer up to 2 years after treatment with radical prostatectomy or brachytherapy.
- Compare the effect of baseline HRQOL, age, and other covariates on HRQOL improvement or deterioration in these patients up to 10 years after these treatments.
- Compare the effect of treatment modality on HRQOL improvement or deterioration in these patients up to 10 years after these treatments.
- Compare the effects of treatment failure on HRQOL, in terms of disease progression, in these patients.
OUTLINE: Patients are randomized to 1 of 2 arms on ACOSOG-Z0070 (radical prostatectomy vs brachytherapy).
Patients in both arms complete a quality of life questionnaire at baseline, 2 and 6 months after treatment, and then at 1, 2, 4, 7, and 10 years after treatment.
PROJECTED ACCRUAL: A total of 500 patients (250 per group) will be accrued for this study within 2 years.
- Conditions
- Prostate Cancer
- Being tested
- quality-of-life assessment
- Keywords
- stage IIB prostate cancer, stage IIA prostate cancer, adenocarcinoma of the prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality-of-life assessmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Quality of life questionnaire | Patients are randomized to 1 of 2 arms on ACOSOG-Z0070 (radical prostatectomy vs brachytherapy).
Patients in both arms complete a quality of life questionnaire at baseline, 2 and 6 months after treatment, and then at 1, 2, 4, 7, and 10 years after treatment as part of ACOSOG-Z0071. Receives: Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to treatment failure
Measured: Up to 10 years
Secondary outcomes (1)
disease progression
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 2002
- Primary completionApr 2004
- Study completionApr 2004
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 Alliance for Clinical Trials in OncologyThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sandra G. Martin, MD, Study chair, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00052481
- Sponsor's protocol ID
- ACOSOG-Z0071
- Other IDs
- ACOSOG-Z0071, CDR0000258478
- Status last verified
- Jul 2016
- First submitted
- 24 Jan 2003
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-Related Quality Of Life In Patients With Low Risk, Localized Prostate Cancer Randomized To Radical Prostatectomy Or Brachytherapy
- ClinicalTrials.gov ID
- NCT00052481
- Acronym / sponsor ID
- ACOSOG-Z0071
- Conditions
- Prostate Cancer
- Keywords
- stage IIB prostate cancer, stage IIA prostate cancer, adenocarcinoma of the prostate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2002
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Quality of life assessment in patients undergoing prostate cancer treatment may help determine the intermediate-term and long-term effects of surgery and brachytherapy.
PURPOSE: Randomized clinical trial to study quality of life in patients undergoing radical prostatectomy or brachytherapy for stage II prostate cancer.
Detailed description
OBJECTIVES:
- Compare changes in health-related quality of life (HRQOL) in patients with stage II prostate cancer up to 2 years after treatment with radical prostatectomy or brachytherapy.
- Compare the effect of baseline HRQOL, age, and other covariates on HRQOL improvement or deterioration in these patients up to 10 years after these treatments.
- Compare the effect of treatment modality on HRQOL improvement or deterioration in these patients up to 10 years after these treatments.
- Compare the effects of treatment failure on HRQOL, in terms of disease progression, in these patients.
OUTLINE: Patients are randomized to 1 of 2 arms on ACOSOG-Z0070 (radical prostatectomy vs brachytherapy).
Patients in both arms complete a quality of life questionnaire at baseline, 2 and 6 months after treatment, and then at 1, 2, 4, 7, and 10 years after treatment.
PROJECTED ACCRUAL: A total of 500 patients (250 per group) will be accrued for this study within 2 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality of life questionnaire | – | Procedure: quality-of-life assessmentPatients are randomized to 1 of 2 arms on ACOSOG-Z0070 (radical prostatectomy vs brachytherapy). Patients in both arms complete a quality of life questionnaire at baseline, 2 and 6 months after treatment, and then at 1, 2, 4, 7, and 10 years after treatment as part of ACOSOG-Z0071. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with adenocarcinoma of the prostate and previously enrolled on ACOSOG-Z0070.
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 |
|---|---|---|
| quality-of-life assessment | Procedure or surgery | Quality of life questionnaire |
Primary outcome
time to treatment failure
Time frame: Up to 10 years
1 secondary outcome
disease progression
Time frame: Up to 10 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 6 Jul 2016.
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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.
Sandra G. Martin, MD study chair
Beth Israel Deaconess Medical Center
13 sites 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 Alliance for Clinical Trials in Oncology at 13 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?
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 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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.
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?
time to treatment failure (time frame: Up to 10 years). 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 6 Jul 2016.