Evaluating Race Specific AGE Accumulation as a Behavioral Biomarker Prostate Cancer Survivors

• ClinicalTrials.gov Identifier: NCT03459755
• Recruitment Status: Withdrawn
• First Posted: March 9, 2018
• Last Update Posted: December 3, 2019
• Sponsor: Medical University of South Carolina
• Information provided by (Responsible Party): Medical University of South Carolina

Study Description

Brief Summary:

The purpose of this study is to show that reduction in advanced glycation end-products (AGEs) is associated with the beneficial regulation of receptor for AGE (RAGE) mediated tumor response which may correlate with improved quality of life in PCa survivors. AGEs are produced by the body and are affected by lifestyle, weight and diet.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Behavioral: Physical Activity	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Evaluating Race Specific AGE Accumulation as a Behavioral Biomarker That Can Reflect Optimal Health in Prostate Cancer Survivors
• Actual Study Start Date: November 27, 2019
• Actual Primary Completion Date: November 27, 2019
• Actual Study Completion Date: November 27, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Lifestyle Intervention; Patients assigned to the Physical Activity arm will undergo exercise testing protocol and have supervised physical activity interventions while on study. Patients will also complete questionnaires and have research blood drawn.	Behavioral: Physical Activity; Patients will have a baseline assessment by undergoing a maximal exercise testing protocol. For 12 weeks, patients will participate in an exercise session 3 days per week The patient will then enter a 12 week "Step Down" program in which the number of sessions is decreased to every week, then every 3 weeks. After the second 12-week period, the patient will enter a 28-week follow up period of unsupervised exercise.
No Intervention: Usual care; Patients will complete questionnaires and have research blood drawn.

Outcome Measures

Primary Outcome Measures :

1. Compare RAGE response (measured in the blood) to changes in Quality of Life using the EORTC QLQ-30 questionnaire. [ Time Frame: From baseline to up to 52 weeks ]
2. Compare RAGE response (measured in the blood) to changes in Quality of Life using the CES-D questionnaire. [ Time Frame: From baseline to up to 52 weeks ]

Secondary Outcome Measures :

1. Effect of Lifestyle intervention (physical activity and diet) on AGE levels measured in the blood [ Time Frame: From baseline up to 52 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 45 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Patient diagnosed with non-metastatic Stage I-III Prostate Cancer
2. Age 45 years and older
3. Within 12 months of first histologic prostate cancer diagnosis.
4. Completed planned chemotherapy and/or radiation therapy 4 weeks or more prior to study.
5. BMI > 25
6. ECOG Performance Status 0 or 1.
7. Access to a telephone.
8. Able to read and understand written and spoken English.
9. Participants must be accessible for treatment and follow-up and must sign informed consent.
10. Subjects with known diabetes are permitted. However, they must be under active treatment for this condition.
11. Participants must past the cardiac rehabilitation center stress test.

Exclusion Criteria:

1. Planned enrollment in other formalized physical activity or diet counseling program during the 12 weeks of study
2. Received chemotherapy or radiation therapy within 4 weeks of enrollment
3. Had previous weight loss surgery (e.g. gastric bypass, sleeve gastrectomy and biliary pancreatic diversion).
4. Previously participated in Cardiac-Rehab
5. Have constrained mobility secondary to problems with balance, bone and/or joint disease
6. Have unstable angina or cardiovascular disease that prohibits exercise.

Contacts and Locations

Locations

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

Medical University of South Carolina

Investigators

• Principal Investigator: David Turner, PhD; Medical University of South Carolina

More Information

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT03459755
• Other Study ID Numbers: 102805; Pro00071004 ( Other Identifier: Medical University of South Carolina )
• First Posted: March 9, 2018
• Last Update Posted: December 3, 2019
• Last Verified: December 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases