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Active, not recruitingNCT01877070Updated Jul 2, 2026

Decision Making in Men With Early Stage Prostate Cancer Patients and Partners/Close Allies

An observational study in Low Risk Prostate Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Active, not recruiting at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by Memorial Sloan Kettering Cancer Center · Observational

Study type
Observational
Model
Family-based
Time perspective
Prospective
Enrollment
541
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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, 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.

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Conditions studied

  • Low Risk Prostate Cancer

Keywords

  • assessments
  • 13-076
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In context

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants will be recruited from outpatient clinics at both the Urology Service at Memorial Sloan-Kettering Cancer Center (MSKCC). Patients may also be contacted by e-mail (securely using MSKSecure) or by mail.

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

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)
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Study design

Observational model
Family-based
Time perspective
Prospective
Enrollment
541 participants (estimated)
Patient registry
No

Groups and cohorts

  • early stage prostate patients & their partners/close allies

    Behavioral: assessments

Interventions

  • Behavioralassessments
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What researchers measure

Primary outcomes

  1. evaluate the impact of anxiety and the inability to tolerate ambiguity

    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.

    Time frame: 2 years

Secondary outcomes

  1. how partners/close allies influence the decision making process

    participants will be administered a set of questionnaires that assess psychological and affective functioning, and treatment preferences.

    Time frame: 2 years

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Study locations

3 sites
  • Memorial Sloan Kettering Westchester
    Harrison, New York 10604, United States
  • Mount Sinai Hospital
    New York, New York 10029, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01877070
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Icahn School of Medicine at Mount Sinai
Responsible party
Sponsor
First posted
Jun 13, 2013
Start date
Jun 2013
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Jul 2, 2026

Study contacts

Yesne Alici, MD
principal investigator · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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