Status:
ACTIVE_NOT_RECRUITING
Decision Making in Men With Early Stage Prostate Cancer Patients and Partners/Close Allies
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Icahn School of Medicine at Mount Sinai
Conditions:
Low Risk Prostate Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to collect information on how patients and their partners/close allies make treatment decisions when they have been diagnosed with early stage prostate cancer.
Detailed Description
Each patient and his partner will fill out assessments at baseline. Thereafter we will obtain the patients' treatment decision (AT or AS) within approximately 6 months. Once a patient makes a decision...
Eligibility Criteria
Inclusion
- For patients:
- Men who meet the NCCN guidelines for low risk prostate cancer, which include all of the following:
- Most recent Gleason score ≤ 6, or clinical stage T1a or less;
- Most recent PSA level below 10;
- In the most recent biopsy, had fewer than 3 positive biopsy cores (with ≤ 50% cancer in each); OR the patient's doctor discussed active surveillance as a treatment option (as documented in visit notes of the patient's medical record)
- Are able to speak, read, write and understand English well enough to provide informed consent and complete study tasks
- Has not made a treatment decision prior to consent, as per self report
- 18 years of age or older
- For partners/close allies:
- Considered a partner/close ally to the patient in the treatment making decision, as reported by the patient
- Are able to speak, read, write and understand English well enough to provide informed consent and complete study tasks
- 18 years old or older
Exclusion
- For patients:
- History of a cancer other than prostate cancer and non-melanoma skin cancer
- Significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in the study activities (i.e., acute psychiatric symptoms which require individual treatment)
- For partners/close allies:
- Significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in the study activities (i.e., acute psychiatric symptoms which require individual treatment)
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
541 Patients enrolled
Trial Details
Trial ID
NCT01877070
Start Date
June 1 2013
End Date
June 1 2026
Last Update
May 28 2025
Active Locations (3)
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1
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
2
Mount Sinai Hospital
New York, New York, United States, 10029
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065