ACT-ED + EME for Prostate Cancer and Erectile Dysfunction

Recruiting in Palo Alto (17 mi)

Overseen by Chris Nelson, PhD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Penile injections

Must not be taking: Androgen deprivation therapy

Disqualifiers: Nerve resection, PSA, Injection phobia, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test two different ways to help men with sexual rehabilitation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently on Androgen Deprivation Therapy (ADT), you would not be eligible to participate.

What data supports the effectiveness of this treatment for prostate cancer and erectile dysfunction?

Research suggests that multidisciplinary sexual rehabilitation, which includes counseling and education, is more promising than traditional treatments for erectile dysfunction after prostate cancer treatment. This indicates that a comprehensive approach like ACT-ED + EME could be effective in improving sexual health outcomes.

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How is the ACT-ED + EME treatment for prostate cancer and erectile dysfunction different from other treatments?

The ACT-ED + EME treatment is unique because it involves in-person sexual rehabilitation sessions, which focus on restoring erectile function through a structured program rather than relying solely on medications or surgical options. This approach may offer a more holistic and supportive environment for patients and their partners compared to traditional treatments.

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Eligibility Criteria

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.

Inclusion Criteria

My prostate cancer is in an early stage with a low to moderate Gleason score.

I had my prostate removed less than 9 months ago.

I had moderate erectile function before surgery.

Exclusion Criteria

I have a major psychiatric disorder that is currently not being treated.

My surgery involved the complete removal of both cavernous nerves.

I am currently on or have been on hormone therapy for cancer.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the ACT-ED or EME intervention, including in-person and phone sessions, focusing on sexual rehabilitation post-prostate cancer surgery.

24 months

3 in-person or phone sessions, 6 brief telephone sessions, 6 monthly phone calls

Follow-up

Participants are monitored for erectile function and adherence to rehabilitation program.

12 months

Questionnaires at 6, 12, 18, and 24 months

Participant Groups

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.

Group I: Standard care plus the ACT intervention (ACT-ED) Experimental Treatment 4 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 Treatment 4 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).

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Memorial Sloan Kettering Cancer Center New York, NY

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center Lead Sponsor

Center for Marital and Sexual Health of South Florida Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of internet-based versus traditional sexual counseling for couples after localized prostate cancer treatment. [2022] After treatment for prostate cancer, multidisciplinary sexual rehabilitation involving couples appears more promising than traditional urologic treatment for erectile dysfunction (ED). The authors of this report conducted a randomized trial comparing traditional or internet-based sexual counseling with waitlist (WL) control.

2. England pubmed.ncbi.nlm.nih.gov

Regenerative technology to restore and preserve erectile function in men following prostate cancer treatment: evidence for penile rehabilitation in the context of prostate cancer survivorship. [2022] Erectile dysfunction (ED) following prostate cancer treatment is not uncommon and penile rehabilitation is considered the standard of care in prostate cancer survivorship (PCS), where both patient and his partner desire to maintain and/or recover pre-treatment erectile function (EF). There is a clinical interest in the role of regenerative therapy to restore EF, since existing ED treatments do not always achieve adequate results.

3. Canada pubmed.ncbi.nlm.nih.gov

Canadian consensus algorithm for erectile rehabilitation following prostate cancer treatment. [2022] The present descriptive analysis carried out by a pan-Canadian panel of expert healthcare practitioners (HCPs) summarizes best practices for erectile rehabilitation following prostate cancer (PCa) treatment. This algorithm was designed to support an online sexual health and rehabilitation e-clinic (SHARe-Clinic), which provides biomedical guidance and supportive care to Canadian men recovering from PCa treatment. The implications of the algorithm may be used inform clinical practice in community settings.

4. France pubmed.ncbi.nlm.nih.gov

[Evaluation of sexual dysfunction in prostate cancer management]. [2015] Prostate cancer patients sexual management and information must evaluate prediagnosis sexual life and impact of cancer on sexuality. Discovery of a pre-existent erectile dysfunction is frequent and must lead to a standard evaluation, involving nature, severity, risks factors (metabolic, cardiovascular and drugs) using a patient and couple centered approach. Advice from an other specialist (sexologist, cardiologist...) can be necessary before to prescribe a drug. Postoperative management of induced sexual dysfunction must be explained and decided according to the patient and couple wishes.

5. India pubmed.ncbi.nlm.nih.gov

Development of UK guidance on the management of erectile dysfunction resulting from radical radiotherapy and androgen deprivation therapy for prostate cancer. [2021] To develop a management strategy (rehabilitation programme) for erectile dysfunction (ED) after radiotherapy (RT) or androgen deprivation therapy (ADT) for prostate cancer that is suitable for use in a UK NHS healthcare context.

6. Ireland pubmed.ncbi.nlm.nih.gov

Dose to penile bulb is not associated with erectile dysfunction 18 months post radiotherapy: A secondary analysis of a randomized trial. [2022] Erectile dysfunction is a common side effect of prostate cancer (PC) therapy. In this randomized study (The RIC-study) we used patient reported outcomes to evaluate sexual function 18 months after combined endocrine therapy and radical radiotherapy (RT) given with either wide or tight planning target volume (PTV) margins. We also analyzed the impact of radiation dose to penile bulb on sexual function.

7. Netherlands pubmed.ncbi.nlm.nih.gov

Penile implant utilization following treatment for prostate cancer: analysis of the SEER-Medicare database. [2022] Prostate cancer treatments, including radical prostatectomy (RP) and radiotherapy (RT), may adversely affect erectile function. Penile implant surgery is a well-recognized erectile dysfunction (ED) treatment for prostate cancer survivors who wish to remain sexually active and in whom nonsurgical treatments are ineffective or unpalatable.