Radium-223 and Radiotherapy in Hormone-Naïve Men With Oligometastatic Prostate Cancer to Bone (RROPE)
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ClinicalTrials.gov Identifier: NCT03304418 |
Recruitment Status :
Recruiting
First Posted : October 9, 2017
Last Update Posted : January 13, 2021
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Tracking Information | |||||||
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First Submitted Date ICMJE | September 27, 2017 | ||||||
First Posted Date ICMJE | October 9, 2017 | ||||||
Last Update Posted Date | January 13, 2021 | ||||||
Actual Study Start Date ICMJE | February 12, 2018 | ||||||
Estimated Primary Completion Date | November 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Time to Androgen Deprivation Therapy (ADT) Use [ Time Frame: 15 months ] Determine if 20% of ADT naïve men treated with concurrent EBRT and Radium-223 will not require ADT for progression by 15 months.
Endpoint: Determine the time from start of study therapy to start of ADT.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Radium-223 and Radiotherapy in Hormone-Naïve Men With Oligometastatic Prostate Cancer to Bone | ||||||
Official Title ICMJE | A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naïve Men With Oligometastatic Prostate Cancer to Bone | ||||||
Brief Summary | This is a phase IIa, open label, single arm, and prospective study of hormone therapy-naïve men with oligometastatic prostate cancer to the bone. The study will test if treating the primary tumor sites and 5 or fewer sites of bone-only metastasis with external beam radiation with concomitant systemic Radium-223 will reduce the utilization of androgen deprivation therapy, improve QOL and improve OS over a the comparator cohort of SWOG intermittent ADT historic cohort. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: This is a phase IIa, open label, single arm, prospective study Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Prostate Cancer Metastatic to Bone | ||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Radium Ra 223 dichloride and radiation, all patients
Interventions:
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
20 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | November 2022 | ||||||
Estimated Primary Completion Date | November 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03304418 | ||||||
Other Study ID Numbers ICMJE | HCI102312 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University of Utah | ||||||
Study Sponsor ICMJE | University of Utah | ||||||
Collaborators ICMJE | Bayer | ||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | University of Utah | ||||||
Verification Date | January 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |