Radium-223 and Radiotherapy in Hormone-Naïve Men With Oligometastatic Prostate Cancer to Bone

NCT03304418 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: HCI102312
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer Metastatic to Bone

Outcome Measures

Primary Outcomes (1)

• 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.

  15 months

Secondary Outcomes (6)

• 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

Study Arms (1)

Radium Ra 223 dichloride and radiation, all patients

EXPERIMENTAL

Drug: Radium Ra 223 Dichloride; Radiation: Radiation

Interventions

Radium Ra 223 Dichloride DRUG

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

Also known as: Xofigo

Radium Ra 223 dichloride and radiation, all patients

Radiation RADIATION

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)

Radium Ra 223 dichloride and radiation, all patients

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
• Creatinine ≤ 1.5 x ULN
• Albumin \> 2.5 mg/dL
• Willing and able to comply with the protocol, including follow-up visits and examinations.

You may not qualify if:

• 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.
• Men who will receive radical prostatectomy to the primary site.
• Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Spinal Cord compression will be defined as 360 degree circumferential obliteration of T2 cerebrospinal fluid signal around the spinal cord. Treatment should be completed for spinal cord compression.
• Severe, active co-morbidity, defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
• Transmural myocardial infarction within the last 6 months

Sponsors & Collaborators

• University of Utah: lead
• Bayer: collaborator

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Interventions

radium Ra 223 dichloride; Radiation

Intervention Hierarchy (Ancestors)

Physical Phenomena

Results Point of Contact

• Title: Clinicaltrials.gov and CTRP Specialist
• Organization: Huntsman Cancer Institute/University of Utah

IITDataManagement@hci.utah.edu

8012136215

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a phase IIa, open label, single arm, prospective study

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 9, 2017
• Study Start: February 27, 2018
• Primary Completion: September 30, 2022
• Study Completion: August 31, 2023
• Last Updated: April 30, 2025
• Results First Posted: January 30, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)