Prostate CancerNCT02706561
Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery
A study testing questionnaires, three in-person sessions and monthly phone calls in people with Prostate Cancer and Erectile Dysfunction, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to test two different ways to help men with sexual rehabilitation. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Cancer, Erectile Dysfunction
- What is being tested?
- questionnaires, three in-person sessions and monthly phone calls
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2015to Dec 2026
- Phase
- Interventional
- 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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- As per medical record, early stage prostate cancer (Pathologic Stage 1/2 with Gleason score </=8; or Pathologic Stage 3 with Gleason score =/< 7)
- As per medical record, radical prostatectomy (RP) conducted either at MSKCC or at another institution
- As per medical record, ≤ 9 months post-RP
- As per medical record, moderate erectile functioning pre-surgery (i.e., 15 or greater on the IIEF Erectile Function Domain (EFD) score, or graded their erections as a 1 or 2 on the standard 5 point Urology Erectile Function scale, or have a score of 6 or greater on the 1-10 pre-surgery erectile function scale on the SMRP assessment or have a total score of 15 or greater on items 2-7 on the Prostrate Quality of Life Survey: Sexual Domain)
- As per self report or as per medical record starting penile injections as part of the erectile rehabilitation program at MSKCC
- In the judgment of the consenting professional able to communicate, comprehend, and complete questionnaires in English
Who cannot join
- Both cavernous nerves fully resected as per surgery report (nerve sparing score of 8 in MSKCC surgeon note), or documented in the progress note that the nerves were fully resected.
- Currently on or has a history of being an Androgen Deprivation Therapy (ADT)
- Has any indication of Prostate-Specific Antigen (PSA)
- As per self report, specific injection phobia
- In the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessment.
- As per self report or as documented in the medical record, current untreated (e.g. no medication no therapy) major psychiatric disorder (schizophrenia, major depression). Patients diagnosed with a major psychiatric disorder will be reviewed by the study PI to determine eligibility prior to consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Rebecca Saracino, PhD, 646-888-0263
About this study
The purpose of this study is to test two different ways to help men with sexual rehabilitation.
- Conditions
- Prostate Cancer, Erectile Dysfunction
- Being tested
- questionnaires, three in-person sessions, monthly phone calls, Acceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED), Enhanced Monitoring and Education (EME)
- Keywords
- 15-317
- Medical subject headings
- Prostatic Neoplasms, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesBehavioural
three in-person sessionsBehavioural
monthly phone callsBehavioural
Acceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED)Behavioural
Enhanced Monitoring and Education (EME)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Standard care plus the ACT intervention (ACT-ED) | Experimental | SC + ACT-ED-Group A uses Acceptance and Commitment Therapy (ACT). In this group, men focus on: long-term goals of rehabilitation; acceptance of the frustration related to ED; identifying and overcoming barriers; and committing to an erectile rehabilitation program. All participants will be asked to complete a set of questionnaires (baseline). The participants can complete it using your personal computer, one of MSKCC computers, in-person or over the phone. The questionnaires will take about 45-60 minutes to complete. You will also complete the same set of questionnaires at 6, 12, 18, and 24 months following study entry. In both groups, the participant will receive three in-person sessions or phone (30-45 minutes), six brief telephone sessions (5-10 minutes), and six monthly phone calls (5-10 minutes) Receives: Behavioral: questionnaires; Behavioral: three in-person sessions; Behavioral: monthly phone calls; Behavioral: Acceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED) |
| SC plus nurse Enhanced Monitoring and Education (EME) | Experimental | SC + EME-Group B uses enhanced monitoring and education. This group focuses on answering questions about the rehabilitation program, manage technical issues related to injections, and the dose titration of injection medication. Participants in this group will also receive education on the side effects and impact of prostate cancer surgery, and strategies for restarting sexual activity. All participants will be asked to complete a set of questionnaires (baseline). You can complete it using your personal computer, one of MSKCC computers, in-person or over the phone. The questionnaires will take about 45-60 minutes to complete. The participant will also complete the same set of questionnaires at 6, 12, 18, and 24 months following study entry. In both groups, the participant will receive three in-person sessions or phone (30-45 minutes), six brief telephone sessions (5-10 minutes), and six monthly phone calls (5-10 minutes). Receives: Behavioral: questionnaires; Behavioral: three in-person sessions; Behavioral: monthly phone calls; Behavioral: Enhanced Monitoring and Education (EME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentages of patients having an Erectile Function Domain (EFD) total score >= 24
The EFD score of >= 24 will be used to indicate "good" erectile function. This is both a face valid cut-off, and a cut off that is commonly used in the literature as "good" erectile function following radical prostatectomy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study start8 Dec 2015
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Marital and Sexual Health of South Florida
- Responsible party
- Sponsor
- Investigators
- Rebecca Saracino, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706561
- Sponsor's protocol ID
- 15-317
- Status last verified
- Apr 2026
- First submitted
- 3 Mar 2016
- Last updated
- 8 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Men Adhere to Sexual Rehabilitation Following Prostate Cancer Surgery
- ClinicalTrials.gov ID
- NCT02706561
- Acronym / sponsor ID
- 15-317
- Conditions
- Prostate Cancer, Erectile Dysfunction
- Keywords
- 15-317
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Center for Marital and Sexual Health of South Florida
- Study start
- 8 Dec 2015
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Mar 2016 (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 test two different ways to help men with sexual rehabilitation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care plus the ACT intervention (ACT-ED) | Experimental | Behavioral: questionnaires, Behavioral: three in-person sessions, Behavioral: monthly phone calls, Behavioral: Acceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED)SC + ACT-ED-Group A uses Acceptance and Commitment Therapy (ACT). In this group, men focus on: long-term goals of rehabilitation; acceptance of the frustration related to ED; identifying and overcoming barriers; and committing to an erectile rehabilitation program. All participants will be asked to complete a set of questionnaires (baseline). The participants can complete it using your personal computer, one of MSKCC computers, in-person or over the phone. The questionnaires will take about 45-60 minutes to complete. You will also complete the same set of questionnaires at 6, 12, 18, and 24 months following study entry. In both groups, the participant will receive three in-person sessions or phone (30-45 minutes), six brief telephone sessions (5-10 minutes), and six monthly phone calls (5-10 minutes) |
| SC plus nurse Enhanced Monitoring and Education (EME) | Experimental | Behavioral: questionnaires, Behavioral: three in-person sessions, Behavioral: monthly phone calls, Behavioral: Enhanced Monitoring and Education (EME)SC + EME-Group B uses enhanced monitoring and education. This group focuses on answering questions about the rehabilitation program, manage technical issues related to injections, and the dose titration of injection medication. Participants in this group will also receive education on the side effects and impact of prostate cancer surgery, and strategies for restarting sexual activity. All participants will be asked to complete a set of questionnaires (baseline). You can complete it using your personal computer, one of MSKCC computers, in-person or over the phone. The questionnaires will take about 45-60 minutes to complete. The participant will also complete the same set of questionnaires at 6, 12, 18, and 24 months following study entry. In both groups, the participant will receive three in-person sessions or phone (30-45 minutes), six brief telephone sessions (5-10 minutes), and six monthly phone calls (5-10 minutes). |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- As per medical record, early stage prostate cancer (Pathologic Stage 1/2 with Gleason score </=8; or Pathologic Stage 3 with Gleason score =/< 7)
- As per medical record, radical prostatectomy (RP) conducted either at MSKCC or at another institution
- As per medical record, ≤ 9 months post-RP
- As per medical record, moderate erectile functioning pre-surgery (i.e., 15 or greater on the IIEF Erectile Function Domain (EFD) score, or graded their erections as a 1 or 2 on the standard 5 point Urology Erectile Function scale, or have a score of 6 or greater on the 1-10 pre-surgery erectile function scale on the SMRP assessment or have a total score of 15 or greater on items 2-7 on the Prostrate Quality of Life Survey: Sexual Domain)
- As per self report or as per medical record starting penile injections as part of the erectile rehabilitation program at MSKCC
Key exclusion criteria (6 listed)
- Both cavernous nerves fully resected as per surgery report (nerve sparing score of 8 in MSKCC surgeon note), or documented in the progress note that the nerves were fully resected.
- Currently on or has a history of being an Androgen Deprivation Therapy (ADT)
- Has any indication of Prostate-Specific Antigen (PSA)
- As per self report, specific injection phobia
- In the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessment.
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 |
|---|---|---|
| questionnaires | Behavioural | SC plus nurse Enhanced Monitoring and Education (EME), Standard care plus the ACT intervention (ACT-ED) |
| three in-person sessions | Behavioural | SC plus nurse Enhanced Monitoring and Education (EME), Standard care plus the ACT intervention (ACT-ED) |
| monthly phone calls | Behavioural | SC plus nurse Enhanced Monitoring and Education (EME), Standard care plus the ACT intervention (ACT-ED) |
| Acceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED) | Behavioural | Standard care plus the ACT intervention (ACT-ED) |
| Enhanced Monitoring and Education (EME) | Behavioural | SC plus nurse Enhanced Monitoring and Education (EME) |
Primary outcome
percentages of patients having an Erectile Function Domain (EFD) total score >= 24
Time frame: 1 year
The EFD score of >= 24 will be used to indicate "good" erectile function. This is both a face valid cut-off, and a cut off that is commonly used in the literature as "good" erectile function following radical prostatectomy.
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 8 Apr 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.
Rebecca Saracino, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaires, three in-person sessions and monthly phone calls in people with Prostate Cancer and Erectile Dysfunction, run by Memorial Sloan Kettering Cancer Center at 1 site 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 6 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: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Rebecca Saracino, PhD (646-888-0263, jamesr@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentages of patients having an Erectile Function Domain (EFD) total score >= 24 (time frame: 1 year). 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 8 Apr 2026.