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NCT01696877 · ClinicalTrials.gov registry record · Phase 1
A Neoadjuvant Study of Androgen Ablation Combined With Cyclophosphamide and GVAX Vaccine for Localized Prostate Cancer
A Phase 1 study of Prostate Cancer Adenocarcinoma in Situ, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT01696877: Completed Phase 1 study of Prostate Cancer Adenocarcinoma in Situ, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT01696877 is a Phase 1 study of Prostate Cancer Adenocarcinoma in Situ that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01696877, a Phase 1 study of Prostate Cancer Adenocarcinoma in Situ, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
This research is being done to see if an investigational prostate cancer vaccine, called GVAX, can safely be given together with a single intravenous injection of a drug called cyclophosphamide to men that will undergo surgery to remove their cancerous prostate glands who have also received standard hormonal therapy.
Primary Outcome
CD8+ T cell infiltration (quantified as log\[CD8 density\]) into the prostate from harvested prostate glands in men with localized prostate cancer receiving neoadjuvant Androgen deprivation therapy alone (2 weeks prior to surgery), or cyclophosphamide and GVAX followed by Androgen deprivation therapy, (with cyclophosphamide/GVAX administered 4 weeks prior to prostatectomy, and Androgen deprivation therapy administered 2 weeks prior to prostatectomy).
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG GVAX
- DRUG degarelix acetate
Study Locations (1)
Maryland
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2013-01-18 |
| Est. Completion | 2018-12-18 |
| Phase | Phase 1 |
What the finished NCT01696877 record still lists
NCT01696877 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 1 condition, with Prostate Cancer Adenocarcinoma in Situ appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT01696877 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01696877 about?
NCT01696877 is a clinical study titled "A Neoadjuvant Study of Androgen Ablation Combined With Cyclophosphamide and GVAX Vaccine for Localized Prostate Cancer". This research is being done to see if an investigational prostate cancer vaccine, called GVAX, can safely be given together with a single intravenous injection of a drug called cyclophosphamide to men that will undergo surgery to remove their cancerous prostate glands who have also received standard...
What is the current status of trial NCT01696877?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2013-01-18. Estimated completion is 2018-12-18.
What conditions does trial NCT01696877 study?
This clinical trial studies the following conditions: Prostate Cancer Adenocarcinoma in Situ.
What interventions are being tested in trial NCT01696877?
The interventions under investigation include: Cyclophosphamide (DRUG), GVAX (DRUG), degarelix acetate (DRUG).
Who is sponsoring clinical trial NCT01696877?
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 NCT01696877 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01696877's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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