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 : September 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Metastatic to Bone||Drug: Radium Ra 223 Dichloride Radiation: Radiation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a phase IIa, open label, single arm, prospective study|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naïve Men With Oligometastatic Prostate Cancer to Bone|
|Actual Study Start Date :||February 12, 2018|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||November 2022|
|Experimental: Radium Ra 223 dichloride and radiation, all patients||
Drug: Radium Ra 223 Dichloride
Radium Ra 223 dichloride will be delivered intravenously at 55 kBq/kg (1.49 mCi)/kg (+/- 10% total dose) for a total of six cycles. 1 cycle= 28 days. The first cycle will commence at study enrollment, then cycles 2-6 will commence after the completion of radiotherapies at 4 week intervals
Other Name: Xofigo
All external beam radiations oligometastatic sites will commence 1 to 2 weeks after administration of Cycle 1 of Radium-223. All subjects will receive Stereotactic body or hypofractionated radiation to sites of bone disease seen on imaging studies. Patients will have the primary tumor sites and 5 or fewer sites of bone-only metastasis treated with external beam radiation.
Any of the following regimens are considered ablative, acceptable and are biologically equivalent to 60Gy EQD2:
- 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.
- Time from start of study therapy to start of ADT. [ Time Frame: 2 years ]Determine the hormone-therapy free survival time for men treated with concurrent EBRT and Radium-223 and determine if it is a 30% risk reduction over the SWOG intermittent ADT historic cohort
- Evaluate health related quality of life (QOL) [ Time Frame: This questionnaire will be given every 3 months for 2 years ]Evaluate health related quality of life (QOL) as scored by the 50 item Expanded Prostate Inventory Composite (EPIC) EPIC urinary, bowel, sexual and hormonal domains.
- Evaluate changes in general function and well being [ Time Frame: This questionnaire will be given every 3 months for 2 years ]Evaluate health related quality of life (QOL)- the PROMIS 29 will be used to assess general function and well-being
- Evaluate time to first skeletal related event (SRE) [ Time Frame: 2 years ]Documentation of complications associated with bone metastases and may include (but not limited to) fractures, spinal cord compression, bone pain, and hypercalcemia.
- Evaluate the PSA doubling time [ Time Frame: 2 years, assessed at every visit in that time period ]Time elapsed from baseline PSA to double in value.
- Evaluate Overall Surival [ Time Frame: 2 years ]
Evaluate overall survival at 2 years relative to the SWOG intermittent ADT historic cohort.
Endpoint: Patients will be followed for survival for two years after study enrollment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03304418
|Contact: Brett Johnsonfirstname.lastname@example.org|
|United States, Utah|
|Huntsman Cancer Institute||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: Brett Johnson 801-587-4429 email@example.com|
|Principal Investigator: Jonathan Tward, MD|