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NCT01655836 · ClinicalTrials.gov registry record · Phase 1
High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
A Phase 1 study of Prostate Cancer and Recurrent Prostate Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Active
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT01655836: Active Phase 1 study of Prostate Cancer and Recurrent Prostate Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
NCT01655836 is a Phase 1 study of Prostate Cancer and Recurrent Prostate Cancer that is active but no longer recruiting, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 42 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01655836, a Phase 1 study of Prostate Cancer and Recurrent Prostate Cancer, is active but no longer recruiting, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
The first technology is called high dose rate brachytherapy. Brachytherapy is sometimes called internal radiation therapy. High dose rate brachytherapy is a procedure that involves temporarily placing radioactive material inside the patient's body for about 10-20 minutes. Then, the remainder of the radiation treatment will be given over a 3 week period using stereotactic body radiation therapy (SBRT). SBRT is a novel treatment modality that involves the delivery of very high individual doses of radiation to tumors with high precision. This allows the doctor to deliver the same amount of radiation in a much shorter time. The purpose of this study is to determine the safety of brachytherapy when combined with hypofractionated SBRT.
Primary Outcome
Data analysis of phase I studies is descriptive. All estimates of dose-specific rates (e.g., response and toxicity) will be presented with corresponding confidence intervals using the exact method.
Conditions Studied
Interventions
- RADIATION Brachytherapy
- RADIATION Stereotactic Body Radiation Therapy
- OTHER Questionnaire administration
- PROCEDURE Quality-of-life assessment
Study Locations (1)
Pennsylvania
- Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2012-10-04 |
| Est. Completion | 2040-01-01 |
| Phase | Phase 1 |
What the registry record for NCT01655836 still lists
NCT01655836 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (93% lower).
The record links to 5 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which Brachytherapy is the first listed.
NCT01655836 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01655836 about?
NCT01655836 is a clinical study titled "High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer". The first technology is called high dose rate brachytherapy. Brachytherapy is sometimes called internal radiation therapy. High dose rate brachytherapy is a procedure that involves temporarily placing radioactive material inside the patient's body for about 10-20 minutes. Then, the remainder of the ...
What is the current status of trial NCT01655836?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2012-10-04. Estimated completion is 2040-01-01.
What conditions does trial NCT01655836 study?
This clinical trial studies the following conditions: Prostate Cancer, Recurrent Prostate Cancer, Adenocarcinoma of the Prostate, Stage IIB Prostate Cancer, Stage IIA Prostate Cancer.
What interventions are being tested in trial NCT01655836?
The interventions under investigation include: Brachytherapy (RADIATION), Stereotactic Body Radiation Therapy (RADIATION), Questionnaire administration (OTHER), Quality-of-life assessment (PROCEDURE).
Who is sponsoring clinical trial NCT01655836?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01655836 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01655836's enrollment target sits among peer trials
42 520th of 735 higher than 212 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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