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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

percentages of patients having an Erectile Function Domain (EFD) total score >= 24

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~4390

0 / 6Eligibility criteria met