Clinical Trials Logo

Clinical Trial Summary

This phase II trial studies how well an exercise program and continuous Fitbit monitoring work for managing metabolic syndrome and cardiovascular disease risk in patients with prostate cancer that has spread to other places in the body (metastatic) or has come back (recurrent) and does not response to treatment (refractory) and are receiving androgen deprivation therapy. Balancing treatment efficacy, drug side effects, and competing comorbidities with prostate cancer is essential. This trial is being done to learn if an exercise program can help to improve metabolic syndrome and cardiovascular (heart) fitness in prostate cancer patients who are receiving androgen deprivation therapy.


Clinical Trial Description

PRIMARY OBJECTIVE: I. Determine the relationship between a 16-week exercise program with continuous Fitbit monitoring and cardiovascular fitness (defined by change in 10-year atherosclerotic cardiovascular disease [ASCVD] risk score), as compared to Fitbit monitoring alone, in prostate cancer patients on androgen deprivation therapy (ADT). SECONDARY OBJECTIVES: I. Determine the length of cardiovascular fitness effect (measured using 10-year ASCVD risk 12 weeks post intervention) for a 16-week exercise program with continuous Fitbit monitoring in prostate cancer patients on ADT. II. Screen for a relationship between a 16-week exercise program with continuous Fitbit monitoring and metabolic syndrome severity (defined by change in metabolic severity index z-score), as compared to Fitbit monitoring alone, in prostate cancer patients on ADT. III. Measure the relationship between the exercise intervention and prostate-specific antigen (PSA) velocity, compared to Fitbit monitoring alone. IV. Measure the relationship between the exercise intervention and physical fitness (using V02 and body composition), compared to Fitbit monitoring alone. V. Measure the relationship between the exercise intervention and physical activity (step count)/heart rate, compared to Fitbit monitoring alone. VI. Measure the relationship between the exercise intervention and physical activity (as measured by the Godin Leisure Time Physical Activity Questionnaire) compared to Fitbit monitoring alone. VII. Measure the relationship between the exercise intervention and, quality of life/symptom burden, compared to Fitbit monitoring alone (measured by the following patient reported surveys: National Cancer Institute-patient reported outcomes-Common Terminology Criteria for Adverse Events [NCI-PRO-CTCAE], Patient Reported Outcomes Measurement Information System [PROMIS] Fatigue and Physical Function, Self Efficacy, European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire Core30 [QLQ-C30] and Prostate Cancer 25 [PR25]). EXPLORATORY OBJECTIVE: I. Explore the relationship between the exercise intervention and markers of insulin resistance, inflammation/immune function and metabolism utilizing pre- and post-intervention peripheral blood analysis. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive general education exercise packet with instruction to exercise regularly for up to 150 minutes weekly. Patients also wear a FitBit daily over 16 weeks. GROUP II: Patients participate in supervised and self-directed exercise sessions over 60 minutes twice a week (BIW) for up to 16 weeks. Patients also wear a FitBit daily over 16 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05054296
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Christopher J Logothetis
Phone 7135637210
Email clogothe@mdanderson.org
Status Recruiting
Phase Phase 2
Start date March 23, 2020
Completion date February 2, 2027

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04716725 - 68Ga-PSMA-11 PET for the Diagnosis of Metastatic Castration Resistant Prostate Cancer Phase 2
Withdrawn NCT05034562 - Gallium-68 PSMA-11 PET in Participants With Prostate Cancer Phase 2
Recruiting NCT03678025 - Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer Phase 3
Active, not recruiting NCT03218826 - PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery Phase 1
Active, not recruiting NCT04033432 - sEphB4-HSA in Treating Patients With Metastatic Castration-Resistant Prostate Cancer Phase 2
Active, not recruiting NCT05496959 - 177-Lutetium-PSMA Before Stereotactic Body Radiotherapy for the Treatment of Oligorecurrent Prostate Cancer, The LUNAR Study Phase 2
Terminated NCT04134208 - An Investigational Scan (18F-Fluciclovine PET-CT) for the Measurement of Therapeutic Response in Patients With Metastatic Prostate Cancer Phase 4
Not yet recruiting NCT06236139 - Cell Therapy (STEAP1 CART) With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer Phase 1/Phase 2
Recruiting NCT04423211 - Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging Phase 3
Completed NCT04976257 - Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion Early Phase 1
Withdrawn NCT04585932 - Androgen Deprivation Therapy and Apalutamide With or Without Radiation Therapy for the Treatment of Biochemically Recurrent Prostate Cancer, RESTART Study Phase 2
Active, not recruiting NCT05241860 - Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM) Phase 2
Recruiting NCT04159896 - ESK981 and Nivolumab for the Treatment of Metastatic Castration Resistant Prostate Cancer Phase 2
Recruiting NCT04314401 - National Cancer Institute "Cancer Moonshot Biobank"
Completed NCT05547386 - 68Ga-PSMA-11 PET/CT Screening Prior to 177Lu-PSMA-617 Therapy for Patients With Metastatic Castrate Resistant Prostate Cancer Phase 3
Recruiting NCT04734730 - Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer Phase 2
Recruiting NCT06200103 - Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer Phase 2
Recruiting NCT06039371 - Supraphysiological Androgen to Enhance Chemotherapy Treatment Activity in Metastatic Castration-Resistant Prostate Cancer, SPECTRA Study Phase 2
Recruiting NCT03866382 - Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors Phase 2
Active, not recruiting NCT04267887 - Advanced ChemoHormonal Therapy for Treatment Naive Metastatic Prostate Cancer Phase 2