Prostate CancerNCT00561444
Quality of Life Study for Prostate Cancer Patients
An observational study of Prostate Cancer, run by M.D. Anderson Cancer Center at 3 sites in United States.
Trial summary
The goal of this behavioral research study is to look at patients' quality of life after treatment or management for prostate cancer. 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?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,051 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Nov 2007to Nov 2020
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with prostate cancer.
Who may be able to join
- Primary treatment at MD Anderson for prostate cancer using: radical retropubic prostatectomy, robotic prostatectomy, photon external beam radiation, photon external beam radiation with hormone therapy, proton radiation, radioisotopic implant, cryotherapy, or active surveillance.
- Neoadjuvant, concurrent and adjuvant androgen ablation in conjunction with photon external beam radiation is allowed if not greater than 6 months total duration. Hormone therapy will be given as an LHRH agonist with or without an antiandrogen.
- Pathologic diagnosis of prostate adenocarcinoma
- AJCC (VI) stage T1-T3b N0M0
- Ability to read, write, and fill out the self-survey questionnaires
- Patients may be simultaneously enrolled on other MD Anderson treatment or laboratory protocols. The EPIC Survey will be used for both this protocol and for protocol 2007-0209 such that patients enrolled on both protocols will complete only one document at each survey point. Simultaneous enrollment on other survey protocols will be handled in a similar manner.
Who cannot join
- Histology other than adenocarcinoma
- Stage T4, nodal or distant metastasis
- Prior treatment for prostate cancer except for neoadjuvant, concurrent and adjuvant androgen deprivation of 6 months or less duration in patients treated with photon radiation. Hormone therapy in all other modalities is not allowed.
- Chemotherapy or molecular targeting therapy as primary, neoadjuvant or adjuvant treatment
- Treatment for another pelvic malignancy, to include surgery or radiation
- Treatment for another malignancy with chemotherapy completed within one year or less of treatment for prostate cancer.
- Inflammatory bowel disease (eg. Crohn's or Ulcerative Colitis)
- Patients 18 years or younger.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
MD Anderson Cancer Center at Albuquerque
Albuquerque, New Mexico, 87110
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
MD Anderson at Cooper
Voorhees Township, New Jersey, 08043
About this study
Official title: A Comprehensive, Multimodality Quality of Life Study for Prostate Cancer Patients
The goal of this behavioral research study is to look at patients' quality of life after treatment or management for prostate cancer.
Read the detailed description
Questionnaires:
You will complete 2 questionnaires that will ask you questions about your quality of life, urinary, bowel, sexual function, and any side effects that you may be having. You will be asked about any medications you may be taking and any other medical conditions you may have. The questionnaires will take about 20 minutes to complete. You may complete the questionnaires at the clinic, have them mailed to you (return postage will be included), or be asked the questions over the phone.
If you are on active surveillance (checking for prostate cancer by routine blood draws and biopsy, without active treatment), you will fill out the questionnaires on the same schedule as those receiving treatment that does not involve hormones.
If you are receiving therapy that does not involve hormones, you will complete the questionnaires before you receive treatment.
If you are receiving hormone therapy, you will complete the questionnaires before beginning the hormone therapy and then again within 3 weeks before starting radiation.
For all participants, at 3 and 6 months after the treatment is completed, you will complete the questionnaires again. Starting 6 months after you finish treatment, you will complete the questionnaires every 6 months for 2 years. Starting 2 years after treatment, you will complete the questionnaires once a year for 3 years.
Length of Study:
All participants will be considered off-study once they have completed the last questionnaires. You will be taken off study early if you receive a second treatment for prostate cancer or if you decide to have treatment while on active surveillance.
This is an investigational study. Up to 1448 patients will be enrolled in this study. All will be enrolled at MD Anderson, MD Anderson Albuquerque, and MD Anderson Cooper.
- Conditions
- Prostate Cancer
- Being tested
- Questionnaire
- Keywords
- Prostate Cancer, Radical retropubic prostatectomy, Robotic prostatectomy, Photon external beam radiation, Photon external beam radiation with hormone therapy, Proton radiation, Radioisotopic implant, Cryotherapy, Quality of Life, Questionnaire, Survey, QOL
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Questionnaires taking 20 minutes to complete.
| Study group | Role | What they receive |
|---|---|---|
| Quality of Life Study | Prostate cancer patients Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
QOL: Expanded Prostate Cancer Index Composite (EPIC) Survey
Measured: Survey prior to beginning treatment, 3 months after completing treatment, 6 months after completing treatment, at 6 month intervals for the first 2 years post-treatment, and then yearly for 3 more years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study start14 Nov 2007
- Primary completionNov 2020 (estimated)
- Study completionNov 2020 (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.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 1,051 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah A. Kuban, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561444
- Sponsor's protocol ID
- 2007-0302
- Status last verified
- Jan 2020
- First submitted
- 20 Nov 2007
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive, Multimodality Quality of Life Study for Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT00561444
- Acronym / sponsor ID
- 2007-0302
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Radical retropubic prostatectomy, Robotic prostatectomy, Photon external beam radiation, Photon external beam radiation with hormone therapy, Proton radiation, Radioisotopic implant, Cryotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,051 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 14 Nov 2007 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 21 Nov 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 goal of this behavioral research study is to look at patients' quality of life after treatment or management for prostate cancer.
Detailed description
Questionnaires:
You will complete 2 questionnaires that will ask you questions about your quality of life, urinary, bowel, sexual function, and any side effects that you may be having. You will be asked about any medications you may be taking and any other medical conditions you may have. The questionnaires will take about 20 minutes to complete. You may complete the questionnaires at the clinic, have them mailed to you (return postage will be included), or be asked the questions over the phone.
If you are on active surveillance (checking for prostate cancer by routine blood draws and biopsy, without active treatment), you will fill out the questionnaires on the same schedule as those receiving treatment that does not involve hormones.
If you are receiving therapy that does not involve hormones, you will complete the questionnaires before you receive treatment.
If you are receiving hormone therapy, you will complete the questionnaires before beginning the hormone therapy and then again within 3 weeks before starting radiation.
For all participants, at 3 and 6 months after the treatment is completed, you will complete the questionnaires again. Starting 6 months after you finish treatment, you will complete the questionnaires every 6 months for 2 years. Starting 2 years after treatment, you will complete the questionnaires once a year for 3 years.
Length of Study:
All participants will be considered off-study once they have completed the last questionnaires. You will be taken off study early if you receive a second treatment for prostate cancer or if you decide to have treatment while on active surveillance.
This is an investigational study. Up to 1448 patients will be enrolled in this study. All will be enrolled at MD Anderson, MD Anderson Albuquerque, and MD Anderson Cooper.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality of Life Study | – | Behavioral: QuestionnaireProstate cancer patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with prostate cancer.
Key inclusion criteria (6 listed)
- Primary treatment at MD Anderson for prostate cancer using: radical retropubic prostatectomy, robotic prostatectomy, photon external beam radiation, photon external beam radiation with hormone therapy, proton radiation, radioisotopic implant, cryotherapy, or active surveillance.
- Neoadjuvant, concurrent and adjuvant androgen ablation in conjunction with photon external beam radiation is allowed if not greater than 6 months total duration. Hormone therapy will be given as an LHRH agonist with or without an antiandrogen.
- Pathologic diagnosis of prostate adenocarcinoma
- AJCC (VI) stage T1-T3b N0M0
- Ability to read, write, and fill out the self-survey questionnaires
Key exclusion criteria (8 listed)
- Histology other than adenocarcinoma
- Stage T4, nodal or distant metastasis
- Prior treatment for prostate cancer except for neoadjuvant, concurrent and adjuvant androgen deprivation of 6 months or less duration in patients treated with photon radiation. Hormone therapy in all other modalities is not allowed.
- Chemotherapy or molecular targeting therapy as primary, neoadjuvant or adjuvant treatment
- Treatment for another pelvic malignancy, to include surgery or radiation
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 |
|---|---|---|
| QuestionnaireAlso: SurveyQuestionnaires taking 20 minutes to complete. | Behavioural | Quality of Life Study |
Primary outcome
QOL: Expanded Prostate Cancer Index Composite (EPIC) Survey
Time frame: Survey prior to beginning treatment, 3 months after completing treatment, 6 months after completing treatment, at 6 month intervals for the first 2 years post-treatment, and then yearly for 3 more years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- The University of Texas M.D.Anderson Cancer CenterLink provided by the sponsor.
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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.
Deborah A. Kuban, MD principal investigator
M.D. Anderson Cancer Center
3 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 M.D. Anderson Cancer Center at 3 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?
The sponsor lists 6 inclusion and 8 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 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
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?
QOL: Expanded Prostate Cancer Index Composite (EPIC) Survey (time frame: Survey prior to beginning treatment, 3 months after completing treatment, 6 months after completing treatment, at 6 month intervals for the first 2 years post-treatment, and then yearly for 3 more 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 14 Jan 2020.