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Urologic Surgery Trials

ENACT: A Randomized Study of Enzalutamide in Patients with Localized Prostate Cancer Undergoing Active Surveillance 
Aims: To see if the drug enzalutamide, an approved treatment for advanced prostate cancer, can delay the progression of early stage prostate cancer. To learn what is best, we need to compare patients taking enzalutamide to patients on active surveillance. In active surveillance men with low grade, low volume prostate cancer are monitored with periodic blood tests and biopsies.  They only have treatment (surgery, radiation) if or when the cancer worsens.  In the sutdy, a computer will randomly place participants in either the enzalutamide or active surveillance group. Patients in the enzalutamide group will be followed with the same tests and biopsies as those in the active surveillance group. 
Diagnosis: Men diagnosed with low or intermediate risk prostate cancer within the last 6 months
Principal Investigator: Brian Helfand, MD, PhD
IRB Approval Number: EH16-237
Sponsor: Astellas Pharma Global Development Inc.
Contact: Study Coordinator, Jasmine Nero at 847.503.3087
Open to Enrollment: Yes

Compliance and Outcomes with Penile Rehabilitation in Men after Prostate Cancer Treatment
Aims: To determine the impact of sexual function rehabilitation on quality of life in men who have undergone prostate cancer treatment with either surgery or radiation therapy. Treatment compliance and satisfaction will be measured. The study involves periodic questionnaires.
Diagnosis: Men with sexual dysfunction following prostate cancer treatment 
Principal Investigator: Jeffrey Albaugh, PhD, APRN
IRB Approval Number: EH13-049
Sponsor: NorthShore University HealthSystem
Contact: Nurse Navigator, Martha McCurdy at 847.503.4245 or Study Coordinator, Nick Kirwen at 847.503.4281
Open to Enrollment: Yes

REASSURE ME: Reducing the Effects of Active Surveillance Stress, Uncertainty and Rumination thru Engagement in Mindfulness Education
Aims: To examine an 8-week health promotion and lifestyle wellness program intended to improve the quality of life in men (and their partners, if applicable) diagnosed with prostate cancer who are being followed by active surveillance.  The study will allow health care professionals to learn more about how these different health and wellness interventions work and if they should become a part of regular supportive care services for patients.
Diagnosis: Men with prostate cancer being followed by active surveillance who were diagnsosed in the last year 
Principal Investigator: Kristian Novakovic, MD
IRB Approval Number: EH15-124
Sponsor: NorthShore University HealthSystem
Contact: Study Coordinator, Nick Kirwen at 847.503.4281
Open to Enrollment: Yes