NCT Number: NCT01877070
Decision Making in Men With Early Stage Prostate Cancer Patients and Partners/Close Allies
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.
This study is active but is not currently recruiting participants.
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Memorial Sloan Kettering Westchester, Harrison, New York, United States
About this study
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, he and his partner will complete another set of questionnaires. The patient and his partner will then complete the remaining questionnaires approximately 6, 12, 18, and 24 months following the treatment decision. We will examine the associations between baseline assessments , and the treatment decision as well as the changes in the assessments and the treatment decision. We will also assess associations between follow-up assessments and the decision to change a treatment decision from AS to AT. Data from patients and partners/close allies will generally be analyzed separately, thus patients who do not have a partner (or partner declines to participate) can still be enrolled and their psychosocial outcomes assessed.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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 criteria
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)
Treatment and study plan
Primary outcomes
-
evaluate the impact of anxiety and the inability to tolerate ambiguity
Time frame: 2 years
on the decision making process in men with prostate cancer who are eligible for active surveillance and their partners/close allies. All participants will be administered a set of questionnaires that assess psychological and affective functioning, and treatment preferences.
Secondary outcomes
-
how partners/close allies influence the decision making process
Time frame: 2 years
participants will be administered a set of questionnaires that assess psychological and affective functioning, and treatment preferences.
Sponsors and collaborators
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Collaborators
- Icahn School of Medicine at Mount Sinai
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jun 13, 2013
- Registry last updated
- Jul 2, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Active Surveillance With or Without Apalutamide Treatment in Low Risk Prostate Cancer
NCT03088124
Low Risk Prostate Cancer
Marseille, Bouches du Rhône, France
View Trial DetailsThe PRECISION Study: 3 Fractions of Prostate SBRT and RayPilot HypoCath Image Guidance
NCT06117059
Genital Diseases, Genital Diseases, Male
Edinburgh, United Kingdom
View Trial DetailsStudy of PSMA PET/CT Imaging to Help Select Men With Low-Risk Prostate Cancer for Active Surveillance
NCT07168616
Clinically Significant Prostate Cancer, Genital Diseases
Istanbul, Turkey, Turkey (Türkiye)
View Trial Details