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ACT-ED + EME for Prostate Cancer and Erectile Dysfunction

N/A
Recruiting
Led By Chris Nelson, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

This trial is testing two different methods to help men with sexual rehabilitation.

Who is the study for?
This trial is for men who've had prostate surgery within the last 9 months and are starting penile injections as part of their sexual rehabilitation. They should have had moderate erectile function before surgery and early stage prostate cancer. Men with both nerves fully resected, on hormone therapy, or with untreated major psychiatric disorders cannot join.Check my eligibility
What is being tested?
The study tests two methods to aid sexual rehabilitation after prostate cancer surgery: Acceptance and Commitment Therapy (ACT-ED) involving three in-person sessions plus monthly calls, versus Enhanced Monitoring and Education (EME). Participants will also complete questionnaires.See study design
What are the potential side effects?
Since this trial involves therapy sessions and education rather than medication, typical drug side effects aren't expected. However, participants may experience emotional discomfort or stress during psychological interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer is in an early stage with a low to moderate Gleason score.
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I have had a radical prostatectomy.
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I had my prostate removed less than 9 months ago.
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I had moderate erectile function before surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My surgery involved the complete removal of both cavernous nerves.
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I am currently on or have been on hormone therapy for cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
percentages of patients having an Erectile Function Domain (EFD) total score >= 24

Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard care plus the ACT intervention (ACT-ED)Experimental Treatment4 Interventions
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)
Group II: SC plus nurse Enhanced Monitoring and Education (EME)Experimental Treatment4 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
questionnaires
2008
Completed Phase 2
~3500

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,944 Previous Clinical Trials
589,527 Total Patients Enrolled
133 Trials studying Prostate Cancer
51,366 Patients Enrolled for Prostate Cancer
Center for Marital and Sexual Health of South FloridaOTHER
1 Previous Clinical Trials
99 Total Patients Enrolled
1 Trials studying Prostate Cancer
99 Patients Enrolled for Prostate Cancer
Chris Nelson, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

three in-person sessions Clinical Trial Eligibility Overview. Trial Name: NCT02706561 — N/A
Prostate Cancer Research Study Groups: Standard care plus the ACT intervention (ACT-ED), SC plus nurse Enhanced Monitoring and Education (EME)
Prostate Cancer Clinical Trial 2023: three in-person sessions Highlights & Side Effects. Trial Name: NCT02706561 — N/A
three in-person sessions 2023 Treatment Timeline for Medical Study. Trial Name: NCT02706561 — N/A
~30 spots leftby Dec 2025
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