ACT-ED + EME for Prostate Cancer and Erectile Dysfunction

Overseen By Andrew Roth, MD

Age: 18+

Sex: Male

Trial Phase: Academic

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 All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 24 months

224 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 5 6 7}

Research Team

Chris Nelson, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

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.

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

Treatment Details

Interventions

• Acceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED)
• Enhanced Monitoring and Education (EME)
• monthly phone calls
• questionnaires
• three in-person sessions

Trial Overview 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.

Participant Groups

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).

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Center for Marital and Sexual Health of South Florida

Collaborator

Trials

2

Recruited

320+

Findings from Research

An internet-based sexual counseling program for couples was found to be as effective as traditional face-to-face therapy in improving sexual function after prostate cancer treatment, with significant improvements in erectile function and female sexual function over 12 months.

The study involved 186 couples, and while 34% dropped out, those who engaged more with the internet program showed greater improvements, indicating that higher participation may enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of internet-based versus traditional sexual counseling for couples after localized prostate cancer treatment. Schover, LR., Canada, AL., Yuan, Y., et al.[2022]

Low-intensity extracorporeal shockwave therapy (LIESWT) shows promise in promoting blood vessel growth and protecting nerves in men with erectile dysfunction (ED) after prostate cancer treatment, although there is limited clinical data specifically for those who have undergone radical prostatectomy.

Regenerative therapies like stem cell therapy (SCT) and platelet-rich plasma (PRP) may help repair damaged tissues and promote healing, but more long-term clinical studies are needed to assess their safety and effectiveness in treating ED.

NCBI (Pubmed)

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. Chung, E.[2022]

A new algorithm for erectile rehabilitation after prostate cancer treatment was developed by a panel of Canadian healthcare experts, taking into account the type of treatment (surgery or radiation) and the patient's individual values.

The algorithm emphasizes the importance of regular sexual activity and partner involvement in decision-making, aiming to provide a comprehensive approach to managing erectile dysfunction in men recovering from prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canadian consensus algorithm for erectile rehabilitation following prostate cancer treatment. Elterman, DS., Petrella, AR., Walker, LM., et al.[2022]

Prostate cancer patients often have pre-existing erectile dysfunction, which should be assessed thoroughly before treatment, considering factors like severity and underlying health issues.

A patient-centered approach is essential for managing sexual dysfunction post-surgery, and collaboration with specialists may be necessary to tailor the best treatment options for patients and their partners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of sexual dysfunction in prostate cancer management]. Savareux, L., Droupy, S.[2015]

Radiotherapy (RT) and androgen deprivation therapy (ADT) for prostate cancer can significantly impair erectile function, necessitating effective management strategies for erectile dysfunction (ED).

A comprehensive treatment algorithm was developed based on a review of 19 articles and expert surveys, recommending a combination of PDE5 inhibitors, exercise, lifestyle changes, psychosexual counseling, and other aids to optimize ED management in this patient group.

NCBI (Pubmed)

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. White, ID., Wilson, J., Aslet, P., et al.[2021]

In a study of 257 men with prostate cancer, erectile dysfunction (ED) was prevalent 18 months after combined endocrine therapy and radiotherapy, with no significant difference in sexual function between those receiving different imaging-guided radiotherapy (IGRT) protocols.

The radiation dose to the penile bulb did not significantly impact erectile function, suggesting that factors like prolonged anti-androgen use may contribute to the high rates of sexual dysfunction observed.

NCBI (Pubmed)

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. Tøndel, H., Lund, JÅ., Lydersen, S., et al.[2022]

In a study of 68,558 men aged 66 and older who underwent treatment for prostate cancer, only 0.8% utilized penile implants, with a higher rate of 2.3% among those who had radical prostatectomy (RP) compared to 0.3% for those who received radiotherapy (RT).

Younger age, being African American or Hispanic, and having undergone RP were significant predictors for the likelihood of receiving a penile implant after prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Penile implant utilization following treatment for prostate cancer: analysis of the SEER-Medicare database. Tal, R., Jacks, LM., Elkin, E., et al.[2022]

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]

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]

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

Canadian consensus algorithm for erectile rehabilitation following prostate cancer treatment. [2022]

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

[Evaluation of sexual dysfunction in prostate cancer management]. [2015]

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]

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]

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

Penile implant utilization following treatment for prostate cancer: analysis of the SEER-Medicare database. [2022]