A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naïve Men With Oligometastatic Prostate Cancer to Bone

University of Utah1 site in 1 country20 target enrollmentFebruary 27, 2018

ConditionsProstate Cancer Metastatic to Bone

InterventionsRadium Ra 223 Dichloride Radiation

DrugsRadium Ra 223 Dichloride

Overview

Phase: Phase 2
Intervention: Radium Ra 223 Dichloride
Conditions: Prostate Cancer Metastatic to Bone
Sponsor: University of Utah
Enrollment: 20
Locations: 1
Primary Endpoint: Count of Participants Requiring Androgen Deprivation Therapy (ADT) Use at 15 Months
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 27, 2018

End Date

August 31, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

University of Utah

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Asymptomatic or symptomatic hormone naïve men with testosterone levels ≥100 ng/dL with previously treated localized prostate cancer who now have rising PSA's and five or fewer bone metastases.
•Subjects who have been previously treated with definitive and/or adjuvant/salvage radiotherapy to the primary site and/or regional lymph nodes with concurrent ADT are allowed if the last hormone therapy delivered \> 6 months prior. Subjects who have had more than 30 days and fewer than 45 days of bicalutamide monotherapy for any reason within the 6 months prior to enrollment are eligible for the study, providing they have been off of the drug for at least 30 days prior to enrollment. Subjects who have had fewer than 30 days of bicalutamide are eligible for the study, as long as they discontinue the drug at least 5 days prior to the first study treatment.
•Histologic confirmation of Prostate Adenocarcinoma diagnosis.
•Age ≥ 18 years.
•Life expectancy of at least 2 years.
•Acceptable hematology and serum biochemistry screening values:
•White Blood Cell Count (WBC) ≥ 3,000/mm3
•Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
•Platelet (PLT) count ≥ 100,000/mm3
•Hemoglobin (HGB) ≥ 10 g/dl

Exclusion Criteria

•Men with known brain or visceral metastases (except regional lymph nodes as defined by section 5.2.5) defined by CT or MRI Imaging of the abdomen or pelvis.
•Men who have had LHRH agonist or antagonist hormone therapy in the prior six months.
•Men with \>5 bony metastases.
•Men with baseline serum Testosterone \<100 ng/dL.
•Men with new or progressing lymphadenopathy clearly consistent with prostate metastasis on imaging or proven by pathologic biopsy at any time three months or later following their initial definitive therapy.
•Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 3 years. All patients with in situ carcinoma are eligible for this study (for example, carcinoma in situ of the oral cavity is eligible) except patients with carcinoma of the bladder (including in situ bladder cancer or superficial bladder cancer).
•Use of finasteride within 30 days prior to therapy PSA should not be obtained prior to 30 days after stopping finasteride.
•Use of dutasteride within 90 days prior to therapy. PSA should not be obtained prior to 90 days after stopping dutasteride.
•Previous or concurrent cytotoxic chemotherapy for prostate cancer.
•Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or Radium Ra 223 dichloride) for the treatment of bony metastases.

Arms & Interventions

Radium Ra 223 dichloride and radiation, all patients

Intervention: Radium Ra 223 Dichloride

Radium Ra 223 dichloride and radiation, all patients

Intervention: Radiation

Outcomes

Primary Outcomes

Count of Participants Requiring Androgen Deprivation Therapy (ADT) Use at 15 Months

Time Frame: 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.

Secondary Outcomes

Median Time From Start of Study Therapy to Start of ADT(2 years)
Mean Expanded Prostate Inventory Composite (EPIC) Scores at End of Treatment(6 months)
Mean PROMIS-29 Scores at End of Treatment(6 months)
Evaluate Time to First Skeletal Related Event (SRE)(2 years)
Evaluate the PSA Doubling Time(2 years, assessed at every visit in that time period)
Evaluate Overall Surival(2 years after study enrollment)