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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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
All external beam radiations oligometastatic sites will commence after cycle 1 of Radium-223 but prior to cycle 2 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: * Single fraction: 16 Gy total at 16 Gy per fraction (SBRT) * Three fractions: 24 Gy total at 8 Gy per fraction (SBRT) * Five fractions: 30 Gy total at 6Gy per fraction (SBRT).When using five fractions, can reduce to 25 Gy total at 5 Gy per fraction (SBRT) or to a minimum of 20 Gy total at 4 Gy per fraction (SBRT), per treating investigator. * Six fractions: 32.4 Gy total at 5.4Gy per fraction (Hypofractionated)
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Count of Participants Requiring Androgen Deprivation Therapy (ADT) Use at 15 Months
To determine if 20% of ADT naïve men treated with concurrent EBRT and Radium-223 will not require ADT for progression by 15 months.
Time frame: 15 months
Median Time From Start of Study Therapy to Start of ADT
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
Time frame: 2 years
Mean Expanded Prostate Inventory Composite (EPIC) Scores at End of Treatment
To 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. EPIC assesses the disease-specific aspects of prostate cancer and its therapies and comprises four summary domains (Urinary, Bowel, Sexual and Hormonal). Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health-related quality of life.
Time frame: 6 months
Mean PROMIS-29 Scores at End of Treatment
To evaluate health related quality of life (QOL). The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) will be used to assess general function and well-being. The raw score for each PROMIS instrument is converted to a T-score on a scale of 0-100. For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T score represents more of the concept being measured. For negatively worded concepts like Anxiety, a T score of 60 is one SD worse than average. By comparison, an Anxiety T score of 40 is one SD better than average. However, for positively worded concepts like Physical Function Mobility, a T score of 60 is one SD better than average while a T score of 40 is one SD worse than average.
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Time frame: 6 months
Evaluate Time to First Skeletal Related Event (SRE)
Documentation of complications associated with bone metastases and may include (but not limited to) fractures, spinal cord compression, bone pain, and hypercalcemia.
Time frame: 2 years
Evaluate the PSA Doubling Time
This outcome measure will report the mean time elapsed from baseline PSA to PSA to double in value. Participants were followed for 24 months from the initiation of study treatment. PSA doubling time was censored at 24 months.
Time frame: 2 years, assessed at every visit in that time period
Evaluate Overall Surival
This outcome measure will report the overall survival at 2 years. Patients were followed for survival for two years after study enrollment. Patients who refused follow-up were censored at their off-study date.
Time frame: 2 years after study enrollment