Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Overweight

Adenocarcinoma

Prostatic Neoplasms

Obesity

Frailty

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Overnutrition

Nutrition Disorders

Body Weight

All Drugs and Chemicals

Androgens

Patients receive an individualized diet plan for 6 months. Patients complete an individualized home-based exercise program aerobic and resistance exercise over 10-30 minutes per day, at minimum 3 days per week for 6 months, and a progressive resistance exercise program including an individually tailored prescription targeting the chest, shoulders, arms, and leg musculature for 1-4 sets of 10-15 repetitions, 5 days per week over 6 months. Patients also attend monthly educational meetings for 6 months.

Dietary Intervention

Educational Intervention

Exercise Intervention

Quality-of-Life Assessment

Survey Administration

Gurkamal S. Chatta

Gurkamal S Chatta

This trial studies how well nutrition and exercise interventions work in reducing androgen deprivation therapy-induced obese frailty in prostate cancer survivors. Individualized nutrition and exercise advice for prostate cancer patients on androgen deprivation therapy may help to reduce obese frailty and change the levels of myokines in blood.

PRIMARY OBJECTIVES:

I. Assess the effect of individualized nutrition and exercise counseling interventions on myokine expression and body composition in prostate cancer (PrCa) patients being treated with androgen deprivation therapy (ADT).

SECONDARY OBJECTIVES:

I. Determine any changes in muscle strength, respiratory muscle strength and functional capacity resulting from the nutrition and exercise counseling interventions.

II. Determine any changes in myokines, circulating inflammatory and frailty-associated cytokines resulting from the nutrition and exercise counseling interventions.

III. Determine the effect of the study interventions on dietary intake, physical activity, fatigue, and quality of life.

EXPLORATORY OBJECTIVES:

I. Correlate changes in secondary objectives with prostate specific antigen (PSA) and testosterone levels.

II. Evaluate adherence to nutrition and exercise advice. III. Evaluate assessment tools and recruiting strategies.

OUTLINE:

Patients receive an individualized diet plan for 6 months. Patients complete an individualized home-based exercise program aerobic and resistance exercise over 10-30 minutes per day, at minimum 3 days per week for 6 months, and a progressive resistance exercise program including an individually tailored prescription targeting the chest, shoulders, arms, and leg musculature for 1-4 sets of 10-15 repetitions, 5 days per week over 6 months. Patients also attend monthly educational meetings for 6 months.

Nutrition and Exercise Interventions in Reducing Androgen Deprivation Therapy-Induced Obese Frailty in Prostate Cancer Survivors

Nutrition and Exercise Interventions to Reduce Androgen Deprivation Therapy-Induced Obese Frailty in Survivors of Advanced Prostate Cancer

Will evaluate the association between changes in the primary biomarkers with serum PSA and androgen levels.

Adherence to advice is qualitative in nature and will be summarized using the appropriate descriptive statistics.

Will be measured by dual X-ray absorptiometry (DXA) total body and regional lean mass, fat mass and % body fat.

Will be assessed by chest press, leg press, grip strength,6-minute walk test, timed-up-and-go, agility, Berg balance scale, short physical performance battery (SPPB).

All subjects will undergo dual-energy X-ray absorptiometry (DEXA) for measurements of body composition

Will be assessed by serum biomarker levels.

Will be used to assess quality of life . The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100, Lower scores = more disability, higher scores = less disability

Will be assessed by National Cancer Institute Automated Self-Administered 24-hour survey.

Will be assessed by Godin Leisure Time survey and Fitbit activity report. Will be summarized by time point using the observed sample size, mean, and standard deviation. Will be evaluated using a two-sided permutation paired t-test. Additionally, the mean change in each outcome will be estimated using a 95% confidence interval. As exploratory analyses, the association between the change in each outcome and demographic/clinical factors may be evaluated using general linear models. The change in outcome will be modeled as a function of baseline levels and each demographic/clinical factor in a one-at-a-time manner.

Will be assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue survey.

Roswell Park Cancer Institute

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Ipilimumab

Immunoglobulins

Antineoplastic Agents, Immunological

Cemiplimab

Immunoglobulins, Intravenous

Immunologic Factors

Immune Checkpoint Inhibitors

Participants receive anti-PD-1 monoclonal antibody REGN2810 IV over 30 minutes on day 1 of week 1 and in week 4, and undergo SBRT for 4 fractions on days 2-5 of week 3. Within 14-21 days, participants undergo radical prostatectomy.

Participants receive ipilimumab via intraprostatic injection on day 1 of week 1, and undergo SBRT for 4 fractions on days 2-5 of week 3. Within 14-21 days, participants undergo radical prostatectomy.

Participants receive anti-PD-1 monoclonal antibody REGN2810 as in Arm A and ipilimumab as in Arm B. Participants also undergo SBRT for 4 fractions on days 2-5 of week 3. Within 14-21 days, participants undergo radical prostatectomy.

Stereotactic Body Radiation Therapy (SBRT)

Radical Prostatectomy

Anti-PD-1 Monoclonal Antibody REGN2810

Adam Dicker, MD

This phase I trial studies the side effects of anti-PD-1 monoclonal antibody REGN2810 (REGN2810) and/or ipilimumab when given together with stereotactic body radiation therapy before surgery in treating participants with prostate cancer that is growing, spreading, or getting worse, and has spread to other places in the body, or formed a small number of new tumors in one or two other parts of the body. Monoclonal antibodies, such as anti-PD-1 monoclonal antibody REGN2810 and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving anti-PD-1 monoclonal antibody REGN2810 and ipilimumab with stereotactic body radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PRIMARY OBJECTIVES:

I. To determine the safety and tolerability for an established effective dose of systemic REGN2810 and intraprostatic ipilimumab with stereotactic body radiation therapy (SBRT) in patients with locally advanced prostate cancer with or without oligometastatic disease.

SECONDARY OBJECTIVES:

I. To determine overall pathologic response rate after radical prostatectomy. II. To determine prostate-specific antigen (PSA) progression free survival in men treated with REGN2810 and intraprostatic ipilimumab with SBRT.

III. To determine radiographic progression free survival in men treated with REGN2810 and intraprostatic ipilimumab with SBRT.

IV. Acute and chronic adverse events (AEs).

Stereotactic Body Radiation Therapy With REGN2810 and/or Ipilimumab Before Surgery in Treating Participants With Progressive Advanced or Oligometastatic Prostate Cancer

R2810-ONC-16XX: A Phase 1 Neoadjuvant Study of Stereotactic Body Radiation Therapy With Systemic REGN2810 and Intraprostatic Ipilimumab, Alone or in Combination, in Patients With Locally Advanced Prostate Cancer Prior to Radical Prostatectomy

Will be assessed by quantifying the toxicities and grades 3 and 4 experienced by subjects who have received REGN2810 + ipilimumab in combination with radiation therapy, including serious adverse events (SAEs) and events of clinical interest (ECIs). Time-to-event continual reassessment (TITE-CRM) design will be used to confirm the safety of the treatments based on toxicities.

Will be presented with appropriate confidence intervals (95%, unless otherwise specified).

Will be estimated using the Kaplan-Meier method.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nutrition and Exercise Interventions in Reducing Androgen Deprivation Therapy-Induced Obese Frailty in Prostate Cancer Survivors	NCT03880422	Cancer Survivor Obesity Overweight Prostate Adenoc... Stage A Prostat... Stage B Prostat... Stage C Prostat... Stage D Prostat... Stage I Prostat... Stage II Prosta... Stage IIA Prost... Stage IIB Prost... Stage IIC Prost... Stage III Prost... Stage IIIA Pros... Stage IIIB Pros... Stage IIIC Pros... Stage IV Prosta... Stage IVA Prost... Stage IVB Prost...	Dietary Interve... Educational Int... Exercise Interv... Quality-of-Life... Survey Administ...	18 Years -	Roswell Park Cancer Institute
Stereotactic Body Radiation Therapy With REGN2810 and/or Ipilimumab Before Surgery in Treating Participants With Progressive Advanced or Oligometastatic Prostate Cancer	NCT03477864	Stage III Prost... Stage IIIA Pros... Stage IIIB Pros... Stage IIIC Pros... Stage IV Prosta... Stage IVA Prost... Stage IVB Prost...	Ipilimumab Stereotactic Bo... Radical Prostat... Anti-PD-1 Monoc...	18 Years -	Thomas Jefferson University
Nutrition and Exercise Interventions in Reducing Androgen Deprivation Therapy-Induced Obese Frailty in Prostate Cancer Survivors	NCT03880422	Cancer Survivor Obesity Overweight Prostate Adenoc... Stage A Prostat... Stage B Prostat... Stage C Prostat... Stage D Prostat... Stage I Prostat... Stage II Prosta... Stage IIA Prost... Stage IIB Prost... Stage IIC Prost... Stage III Prost... Stage IIIA Pros... Stage IIIB Pros... Stage IIIC Pros... Stage IV Prosta... Stage IVA Prost... Stage IVB Prost...	Dietary Interve... Educational Int... Exercise Interv... Quality-of-Life... Survey Administ...	18 Years -	Roswell Park Cancer Institute
Nutrition and Exercise Interventions in Reducing Androgen Deprivation Therapy-Induced Obese Frailty in Prostate Cancer Survivors	NCT03880422	Cancer Survivor Obesity Overweight Prostate Adenoc... Stage A Prostat... Stage B Prostat... Stage C Prostat... Stage D Prostat... Stage I Prostat... Stage II Prosta... Stage IIA Prost... Stage IIB Prost... Stage IIC Prost... Stage III Prost... Stage IIIA Pros... Stage IIIB Pros... Stage IIIC Pros... Stage IV Prosta... Stage IVA Prost... Stage IVB Prost...	Dietary Interve... Educational Int... Exercise Interv... Quality-of-Life... Survey Administ...	18 Years -	Roswell Park Cancer Institute

Spots Global Cancer Trial Database for stage iiic prostate cancer