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

NCT03459755 | Withdrawn DMC

• 2 other identifiers: 102805Pro00071004
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Compare RAGE response (measured in the blood) to changes in Quality of Life using the EORTC QLQ-30 questionnaire.

  From baseline to up to 52 weeks

• Compare RAGE response (measured in the blood) to changes in Quality of Life using the CES-D questionnaire.

  From baseline to up to 52 weeks

Secondary Outcomes (1)

• Effect of Lifestyle intervention (physical activity and diet) on AGE levels measured in the blood

  From baseline up to 52 weeks

Study Arms (2)

Lifestyle Intervention

EXPERIMENTAL

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

Usual care

NO INTERVENTION

Patients will complete questionnaires and have research blood drawn.

Interventions

Physical Activity BEHAVIORAL

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.

Lifestyle Intervention

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• David Turner, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 9, 2018
• Study Start: November 27, 2019
• Primary Completion: November 27, 2019
• Study Completion: November 27, 2019
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)