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Prostate CancerNCT01386684

Real Life Evaluation of Lupron in the Management of Prostate Cancer: A Canadian Post Marketing Observational Study

An observational study of Prostate Cancer, run by AbbVie (prior sponsor, Abbott).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the Canadian Real Life Evaluation of the Effectiveness of Lupron in the Management of 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
How many people
552 participants
Where
No sites listed yet
Study dates
28 Jun 2011to 8 Sep 2016
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 will be enrolled from the offices of university or community urologists/oncologists across Canada treating patients with PCa.

Who may be able to join

  • Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel
  • Diagnosed with Prostate Cancer
  • Prescribed Lupron as part of his treatment by his treating physician

Who cannot join

  • Currently participating in another prospective study including controlled clinical trials and observational studies.
  • Patient cannot or will not sign informed consent
  • Survival expectancy less than 2-3 years as per the treating physician's judgment
  • Presence of other condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of Prostate Cancer
  • History of alcohol or drug abuse
  • No longer than 6 months of therapy if currently on luteinizing hormone-releasing hormone (LHRH) treatment

About this study

Official title: Canadian Real-Life Evaluation of the Effectiveness of Lupron in the Management of Prostate Cancer (CRONOS)

The purpose of this study is to evaluate the Canadian Real Life Evaluation of the Effectiveness of Lupron in the Management of Prostate Cancer.

Read the detailed description

This is a Canadian Post Marketing Observational Study utilizing a prospective cohort design. Patients with Prostate Cancer who are prescribed Lupron will be entered into the study cohort and will be followed for a maximum of 36 months with recommended assessments at 3, 6, 12, 18, 24, 30 and 36 months after baseline. Treatment of the patients and follow up will be according to the physician's judgment, regional regulations and the product monograph.

Conditions
Prostate Cancer
Keywords
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.

Study groups in NCT01386684
Study groupRoleWhat they receive
Patients with Prostate CancerPatients with prostate cancer who were receiving treatment with leuprolide acetate (Lupron).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to Biochemical Progression Based on Doubling of Prostate Specific Antigen (PSA) Velocity or PSA > 5.0

    PFS defined as the time from patient recruitment to biochemical progression based on doubling of prostate specific antigen (PSA) velocity or PSA > 5.0, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.

    Measured: 36 months

  2. Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to a Change to an Absolute Value of PSA > 2 ng/mL on at Least 2 Consecutive Tests

    A second definition of PFS was used due to changes in the definition of biochemical progression: the time from patient recruitment to a change to an absolute value of PSA > 2 ng/mL on at least 2 consecutive tests, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.

    Measured: 36 months

Secondary outcomes (34)
  1. Castration Resistant Prostate Cancer (CRPC): Number of Participants

    CRPC defined as PSA > 2 ng/mL on at least 2 consecutive tests.

    Measured: 36 months

  2. Castration Resistant Prostate Cancer (CRPC): Time to Event

    CRPC defined as PSA > 2 ng/mL on at least 2 consecutive tests. The distribution of time to CRPC was estimated using Kaplan-Meier methodology. The point estimate and standard error of the distribution are provided.

    Measured: 36 months

  3. Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit

    Total serum testosterone was assessed at each study visit. The percentage of participants with total serum testosterone ≤ 0.7 nmol/L, > 0.7 to ≤ 1.7 nmol/L, and > 1.7 nmol/L are provided at each time point.

    Measured: Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36

  4. Total Serum Testosterone Levels at Each Visit

    Total serum testosterone was assessed at each study visit.

    Measured: Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36

  5. Total Serum Testosterone: Time to Increase Over Castrate Levels

    Total serum testosterone was assessed at each study visit. The time to increased total serum testosterone over the castrate levels (>1.7 nmol/L) are provided. The distribution of time to increase in total serum testosterone levels was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.

    Measured: 36 months

  6. Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit

    Serum PSA was assessed at each study visit. The percentage of participants with serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL are provided at each time point.

    Measured: Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36

  7. Prostatic Specific Antigen (PSA) Levels at Each Visit

    Serum PSA was assessed at each study visit.

    Measured: Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36

  8. Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit

    The FACT-G questionnaire is used with patients of any tumor type to assess patient quality of life (QoL). FACT-G is a self-administered, 28-item questionnaire assessing physical, functional, social and emotional well-being, as well as patient satisfaction with treatment. All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much). The FACT-G total score is computed as the sum of the four subscale scores and has a possible range of 0-108. Higher scores indicate better QoL. Change in FACT-G was analyzed using repeated measures mixed effects general linear model (GLM). A positive change from baseline indicates improved QoL.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  9. Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit

    The FACT-P questionnaire is used with patients with prostate cancer to assess patient quality of life (QoL). FACT-P is a self-administered, 28-item questionnaire assessing physical, functional, social and emotional well-being, as well as patient satisfaction with treatment. All questions in the FACT-P use a 5-point rating scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much). The FACT-P total score is computed as the sum of the four subscale scores and has a possible range of 0-108. Higher scores indicate better QoL. Change in FACT-P was analyzed using repeated measures mixed effects general linear model (GLM). A negative change from baseline indicates decreased QoL.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  10. International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit

    IIEF-5 is a 5-item, self-administered questionnaire assessing the presence and severity of erectile dysfunction. A score of 1 (very low) to 5 (very high) is awarded to each of the 5 questions. The IIEF-5 total score is a sum of the responses to the 5 items. Total scores range from 5 to 25, with higher scores indicating less dysfunction. Change in IIEF-5 was analyzed using repeated measures mixed effects general linear model (GLM). A negative change from baseline indicates an increase in dysfunction.

    Measured: Month 0 (Baseline) and Months 6, 12, 18, 24, 30, and 36

  11. Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications

    The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  12. Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer

    The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  13. Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer

    The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  14. Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer

    The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  15. Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer

    The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  16. Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer

    The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  17. Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer

    The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  18. Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer

    The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  19. Health Care Utilization and Health Economics Questionnaire: Number of Times That an Ambulance Service Was Used for Prostate Cancer

    The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  20. Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer

    The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  21. Health Care Utilization and Health Economics Questionnaire: Number of Visits For Complementary/Alternate Therapy for Prostate Cancer

    The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  22. Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer

    The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  23. Health Care Utilization and Health Economics Questionnaire: Number of Visits For Any Other Medical Service for Prostate Cancer

    The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  24. Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer

    The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  25. Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer

    The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  26. Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer

    The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  27. Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer

    The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  28. Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer

    The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  29. Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer

    The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  30. Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer

    The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  31. Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer

    The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  32. Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer

    The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.

    Measured: Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36

  33. Treatment Compliance

    Treatment compliance by participants was assessed as the number of missed injections since the last visit.

    Measured: Months 3, 6, 12, 18, 24, 30, and 36

  34. Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit.

    Participants were asked "Have there been any changes in the current prostate cancer treatment (not including Lupron) since last visit?"; if Yes, was the change "Initiation of new mediation/Change in Dose/Frequency" or "Discontinuation of medication". The percentage of subjects at each visit with a change in current prostate cancer treatment (Initiation or Change in Dose/Frequency or Discontinuation of Medication) is presented.

    Measured: Months 3, 6, 12, 18, 24, 30, and 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2011 (estimated)
  2. Study start28 Jun 2011
  3. Primary completion8 Sep 2016
  4. Study completion8 Sep 2016

Resources

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
552 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01386684
Sponsor's protocol ID
P12-811
Status last verified
Aug 2017
First submitted
30 Jun 2011
Last updated
13 Dec 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer, run by AbbVie (prior sponsor, Abbott).

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 3 inclusion and 6 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 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 2 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to Biochemical Progression Based on Doubling of Prostate Specific Antigen (PSA) Velocity or PSA > 5.0 (time frame: 36 months). The study lists 2 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 13 Dec 2018.

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