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High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer

StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description shortened, about 23 words
    • Publications: details revised at 26 of 26 entries
  2. Study description expanded, about 10 wordsv23
  3. Re-verified, no change to tracked fieldsv22
  4. Phase: Not applicable to Phase 1v21
  5. Secondary endpoints: details revised at 4 of 4 entriesv20
Show 18 earlier versionsHide 18 earlier versions
  1. Phase: Phase 1 to Not applicablev19
  2. 3 versions Re-verified since Dec 7, 2020, no change to tracked fieldsv16-v18
  3. Study completion date: Sep 2019 to Jan 1, 2040v15
  4. Re-verified, no change to tracked fieldsv14
  5. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Sep 2018 to Jul 27, 2016
    • Start date: Oct 2012 to Oct 4, 2012
    • Site details revised
    v13
  6. Lead sponsor: Thomas Jefferson University to Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson Universityv12
  7. 5 versions Re-verified since May 2, 2014, no change to tracked fieldsv7-v11
  8. Primary completion date: Sep 2017 to Sep 2018v6
  9. Site contact updatedv5
  10. Site contact updatedv4
  11. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 2012 to Oct 2012
    • Site details revised
    v3
  12. Start date: Jul 2012 to Sep 2012v2 Show 4 more changesShow less
    • Primary completion date: Jul 2017 to Sep 2017
    • Study completion date: Jul 2019 to Sep 2019
    • Study description shortened, about 98 words
    • Publications: 1 to 26
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT01655836
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Conditions
(from sponsor)		 Prostate Cancer, Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov