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

NCT03329742 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2021-03-29

No results posted yet for this study

Summary

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).

Conditions

  • Prostate Cancer Recurrent

Interventions

OTHER

Low protein diet

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).

OTHER

Control 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).

Sponsors & Collaborators

  • Indiana University School of Medicine

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • Nabil Adra, MD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-19
Primary Completion
2019-10-21
Completion
2020-05-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03329742 on ClinicalTrials.gov