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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two new methods to aid men in sexual rehabilitation after prostate cancer surgery. One group will use Acceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED) to focus on setting long-term goals and overcoming barriers related to erectile dysfunction. The other group will receive Enhanced Monitoring and Education (EME) to help manage treatment and understand the effects of surgery. Men with early-stage prostate cancer who have undergone surgery in the past nine months might be a good fit, especially if they are starting a program involving penile injections for erectile rehabilitation. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative approaches in 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Acceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED) is practical and yields positive results for men dealing with erectile dysfunction after prostate cancer treatment. Studies indicate that participants in ACT-ED report greater satisfaction with their treatment and find it easier to adhere to their rehabilitation programs.

Specific safety data for the Enhanced Monitoring and Education (EME) approach is not available. However, EME primarily involves education and monitoring through activities like phone calls and educational sessions, which are generally low-risk. This suggests that any risks associated with EME are likely minimal.

Both ACT-ED and EME use non-invasive methods such as therapy sessions and education, making them easy to manage. Research has not shown any harmful side effects from either approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ACT-ED and EME approaches for prostate cancer and erectile dysfunction because they offer a more holistic and personalized way to tackle these conditions. Unlike standard treatments that primarily focus on medication or surgery, the ACT-ED approach emphasizes psychological support through Acceptance and Commitment Therapy, helping patients focus on long-term goals and overcome personal barriers to rehabilitation. Meanwhile, the EME approach includes enhanced monitoring and education, addressing technical issues and providing guidance on side effects and sexual activity post-surgery. These new strategies aim to empower patients with knowledge and support, potentially improving their overall rehabilitation experience and outcomes.

What evidence suggests that this trial's treatments could be effective for prostate cancer and erectile dysfunction?

This trial will compare two approaches for managing erectile dysfunction after prostate cancer treatment: Acceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED) and Enhanced Monitoring and Education (EME). Research has shown that ACT-ED can be helpful. In studies, men using ACT-ED were more likely to use penile injections, which assist with erectile function. After four months, these participants reported using injections more often than those using other methods, indicating better involvement and possible improvement in function.

Enhanced Monitoring and Education (EME) also has supportive evidence. It focuses on teaching participants how to manage treatment side effects and resume sexual activity. Studies suggest that structured education and support can lead to better outcomes for erectile dysfunction after prostate cancer treatment, potentially improving quality of life.

Both approaches in this trial show promising results for helping men effectively manage erectile dysfunction. ^{1 2 6 7 8}

Who Is on the Research Team?

Chris Nelson, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6943977/

Acceptance and Commitment Therapy to Increase ... ACT-ED is feasible and significantly increases the use of penile injections. ACT-ED also shows promise (moderate effects) for increasing ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31277968/

Acceptance and Commitment Therapy to Increase Adherence ... Main outcome measure: Primary outcomes were feasibility and use of penile injections. Secondary outcomes were ED treatment satisfaction (ie, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01275404

Therapy for Erectile Dysfunction Adaptation of ACT ... Part B will consist of a randomized pilot study where 70 men will be randomly assigned to one of two conditions: Sexual Medicine Rehabilitation (SMRP) plus ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1743609519312226

Acceptance and Commitment Therapy to Increase ... The study acceptance rate was 61%. At 4 months, the ACT-ED group utilized more penile injections per week (1.7) compared to the EM group (0.9) (d = 1.25 ...

5. bmcurol.biomedcentral.com bmcurol.biomedcentral.com/articles/10.1186/s12894-025-01702-0

Use of erectile dysfunction treatments after prostate cancer ... At three and six months after PCa treatment most men reported that oral medication use had no impact on their sex life (72% and 62.7%, ...

6. auajournals.org auajournals.org/doi/pdf/10.1097/JU.0000000000003251.01

PD11-01 ACCEPTANT AND COMMITMENT THERAPY TO ... CONCLUSIONS: Preliminary analysis suggests ACT signifi- cantly increases ICI use. Data also indicate that ACT helps increase men's satisfaction ...

7. withpower.com withpower.com/trial/phase-erectile-dysfunction-11-2015-66abe

ACT-ED + EME for Prostate Cancer and Erectile Dysfunction This N/A medical study run by Memorial Sloan Kettering Cancer Center is evaluating whether three in-person sessions will have tolerable side effects ...

8. researchgate.net researchgate.net/publication/388555124_Use_of_erectile_dysfunction_treatments_after_prostate_cancer_treatment_and_their_perceived_impact_on_men's_sex_life_an_analysis_of_patient_reported_outcome_survey_data

Use of erectile dysfunction treatments after prostate cancer ... Results Post-treatment use of ED treatments did not exceed 43% at any timepoint, with utilisation rates decreasing over time. Oral medications ...