Low Risk Prostate CancerNCT01877070
Decision Making in Men With Early Stage Prostate Cancer Patients and Partners/Close Allies
An observational study of Low Risk Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Risk Prostate Cancer
- What is being tested?
- assessments
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 541 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2013to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Mount Sinai Hospital
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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.
- Conditions
- Low Risk Prostate Cancer
- Being tested
- assessments
- Keywords
- assessments, 13-076
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessmentsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| early stage prostate patients & their partners/close allies | Not described Receives: Behavioral: assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Risk Prostate CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 541 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- Yesne Alici, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877070
- Sponsor's protocol ID
- 13-076
- Status last verified
- Jul 2026
- First submitted
- 11 Jun 2013
- Last updated
- 2 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Making in Men With Early Stage Prostate Cancer Patients and Partners/Close Allies
- ClinicalTrials.gov ID
- NCT01877070
- Acronym / sponsor ID
- 13-076
- Conditions
- Low Risk Prostate Cancer
- Keywords
- assessments, 13-076
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 541 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- Jun 2013
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Jun 2013 (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 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, 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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| early stage prostate patients & their partners/close allies | – | Behavioral: assessments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- Men who meet the NCCN guidelines for low risk prostate cancer, which include all of the following:
- 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
- Considered a partner/close ally to the patient in the treatment making decision, as reported by the patient
Key exclusion criteria (5 listed)
- 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)
- 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)
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 |
|---|---|---|
| assessments | Behavioural | early stage prostate patients & their partners/close allies |
Primary outcome
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.
1 secondary outcome
how partners/close allies influence the decision making process
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Memorial Sloan Kettering 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.
Yesne Alici, MD principal investigator
Memorial Sloan Kettering 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 Low Risk Prostate Cancer, run by Memorial Sloan Kettering 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 12 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
evaluate the impact of anxiety and the inability to tolerate ambiguity (time frame: 2 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 2 Jul 2026.