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Patients on this arm will receive a prescribed diet (including all food and recommendations for beverages) that contains 10% protein to begin eating 1 week prior to treatment with sipuleucel-T and throughout treatment (i.e. diet will last approximately 49 days).

Low protein diet

Patients on this arm will receive a prescribed diet (including all food and recommendations for beverages) that contains 20% protein to begin eating 1 week prior to treatment with sipuleucel-T and throughout treatment (i.e. diet will last approximately 49 days).

Control protein diet

Nabil Adra, MD

This is a single-center, randomized, open-label study to assess the feasibility of a low-protein diet intervention in patients with metastatic castrate-resistant prostate cancer (CRPC) who are receiving treatment with sipuleucel-T. Subjects will be randomized (1:1 ratio) to either Arm 1 or Arm 2 (Fig. 1).

Arm 1: Subjects randomized to Arm 1 will be treated with sipuleucel-T infusion on Day 1, every two weeks for a total of three infusions. Subjects on this arm will receive a control diet containing 20% protein.

Arm 2: Subjects randomized to Arm 2 will be treated with sipuleucel-T infusion on Day 1, every two weeks for a total of three infusions. Subjects on this arm will receive a low-protein diet containing 10% protein.

Patients with metastatic, asymptomatic or minimally symptomatic CRPC that has progressed despite androgen deprivation therapy will be eligible for the study. After informed consent eligible patients will be scheduled to receive sipuleucel-T (three infusions two weeks apart) with normal-protein diet vs. low-protein diet. Each cycle will be every 14 days. Diet intervention will commence 1 week prior to the first apheresis (Day -7) and will continue until 10 days after the last infusion of sipuleucel-T (Day +42) (Fig. 2).

Primary Objective To assess the feasibility of low-protein diet intervention in patients with metastatic CRPC receiving immunotherapy with sipuleucel-T. Change in blood urea nitrogen (BUN) and urine urea nitrogen (UUN) from baseline to 6 weeks will be measured to assess adherence of following the diet intervention. The expected changes (mean, standard deviation) in BUN are 5.5 ± 2.6 mg/dL with 10% protein diet arm and 2.5 ± 2.6 mg/dL with 20% protein diet arm (please see section 12.5.7).

Secondary Objectives

1. To assess whether low-protein diet intervention augments the immune response to sipuleucel-T in men with metastatic CRPC.
2. To assess the safety and tolerability of the combination of sipuleucel-T and low-protein diet intervention.
3. To obtain preliminary evidence of clinical efficacy of the combination of sipuleucel-T and low-protein diet compared to sipuleucel-T and control-diet, including objective response rate (partial + complete response), progression-free survival (PFS) and overall survival (OS), and changes in prostate-specific antigen (PSA).

This is a longitudinal randomized parallel groups design of n=30 subjects randomized in a 1:1 ratio to either sipuleucel-T plus control diet arm (20% protein content) or sipuleucel-T plus intervention low-protein content diet (10% protein diet).

This study is for men with asymptomatic or minimally symptomatic, metastatic, androgen independent prostate cancer.

Sipuleucel-T and Low-protein Diet in Patients With Metastatic Castrate-resistant Prostate Cancer

A Pilot Feasibility Study of Sipuleucel-T vs. Sipuleucel-T and Low-protein Diet in Patients With Metastatic Castrate-resistant Prostate Cancer (CRPC)

IFN-γ ELISpot specific for PA2024 laboratory values

Length of time during and after the treatment that a patient lives with the disease but it does not get worse

Length of time start of treatment that patients are still alive

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Sipuleucel-T and Low-protein Diet in Patients With Metastatic Castrate-resistant Prostate Cancer	NCT03329742	Prostate Cancer...	Low protein die... Control protein...	18 Years -	Indiana University
Sipuleucel-T and Low-protein Diet in Patients With Metastatic Castrate-resistant Prostate Cancer	NCT03329742	Prostate Cancer...	Low protein die... Control protein...	18 Years -	Indiana University

Spots Global Cancer Trial Database for control protein diet