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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: Completed NA study, sponsored by Indiana University.
NCT03329742 is a NA study that has completed, run by Indiana University. The registered enrollment target is 2 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
BUN and UUN laboratory values
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 |
What the finished NCT03329742 record still lists
NCT03329742 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Low protein diet is the first listed.
NCT03329742 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03329742's enrollment target sits among peer trials
2 1997th of 2000 the lowest of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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