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NCT01317199 · ClinicalTrials.gov registry record · Phase 1
Effects of Two Doses of MPX Capsules on Rising Prostate-specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer
A Phase 1 study of Prostate Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 1
- Development phase
- 143
- Enrollment target
- 8
- Study locations
NCT01317199: Completed Phase 1 study of Prostate Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT01317199 is a Phase 1 study of Prostate Cancer that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 143 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (76% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01317199, a Phase 1 study of Prostate Cancer, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 143 participants
- Enrollment target
- 8
- Study locations
Study Summary
This research is being done to test an investigational product called Muscadine Plus in the treatment of men who have received initial therapy (surgery and or radiation, cryotherapy or brachytherapy) for prostate cancer and are experiencing a rise in their prostate-specific antigens (PSA) level.
Primary Outcome
To determine the recommended dosing for Muscadine Plus and to evaluate the safety and tolerability of Muscadine Plus in prostate cancer patients with rising PSA following definitive therapy.
Conditions Studied
Interventions
- DRUG Placebo oral capsule
- DRUG Muscadine Plus Grape Skin Extract
- DRUG Low-dose MPX
- DRUG High-dose MPX
Study Locations (8)
District of Columbia
- Sibley Memorial Hospital - Washington D.C.
- Howard University College of Medicine - Washington D.C.
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- Dana Farber Cancer Institute - Boston
Maryland
- Johns Hopkins Hospital - Baltimore
Michigan
- Karmanos Cancer Institute - Detroit
New Jersey
- Cancer Institute of New Jersey - New Brunswick
New York
- Roswell Park Cancer Institute - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2011-07 |
| Est. Completion | 2015-11 |
| Phase | Phase 1 |
What the finished NCT01317199 record still lists
NCT01317199 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which Placebo oral capsule is the first listed.
NCT01317199 lists 8 locations in 6 states (District of Columbia, Massachusetts, Maryland).
Frequently Asked Questions
What is clinical trial NCT01317199 about?
NCT01317199 is a clinical study titled "Effects of Two Doses of MPX Capsules on Rising Prostate-specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer". This research is being done to test an investigational product called Muscadine Plus in the treatment of men who have received initial therapy (surgery and or radiation, cryotherapy or brachytherapy) for prostate cancer and are experiencing a rise in their prostate-specific antigens (PSA) level.
What is the current status of trial NCT01317199?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 143 participants. The study started on 2011-07. Estimated completion is 2015-11.
What conditions does trial NCT01317199 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT01317199?
The interventions under investigation include: Placebo oral capsule (DRUG), Muscadine Plus Grape Skin Extract (DRUG), Low-dose MPX (DRUG), High-dose MPX (DRUG).
Who is sponsoring clinical trial NCT01317199?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01317199 being conducted?
This trial has 8 study locations across District of Columbia, Maryland, Massachusetts, Michigan, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01317199's enrollment target sits among peer trials
143 277th of 735 higher than 459 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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.
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