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NCT03329742 · ClinicalTrials.gov registry record · NA
Sipuleucel-T and Low-protein Diet in Patients With Metastatic Castrate-resistant Prostate Cancer
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 2
- Enrollment target
NCT03329742 is a NA study that has completed, run by Indiana University. The registered enrollment target is 2 participants.
The verdict
NCT03329742, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
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).
Interventions
- OTHER Low protein diet
- OTHER Control protein diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2017-12-19 |
| Est. Completion | 2020-05-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03329742
The ClinicalTrials.gov registry entry for NCT03329742 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Low protein diet is the first listed.
NCT03329742 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03329742 about?
NCT03329742 is a clinical study titled "Sipuleucel-T and Low-protein Diet in Patients With Metastatic Castrate-resistant Prostate Cancer". 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 (Fi...
What is the current status of trial NCT03329742?
This trial is currently completed. It is a NA study. The enrollment target is 2 participants. The study started on 2017-12-19. Estimated completion is 2020-05-05.
What interventions are being tested in trial NCT03329742?
The interventions under investigation include: Low protein diet (OTHER), Control protein diet (OTHER).
Who is sponsoring clinical trial NCT03329742?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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