Metabolic Change in Prostate Cancer Bone Metastases on 68Ga-HBED-CC-PSMA PET/CT Following Radium-223 Therapy

NCT03062254 | Completed Phase 2

• 1 other identifier: 17-029
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Broadly, the objective of this study is to evaluate the fractional decline of intensity of tracer uptake measured by SUVmax on 68Ga-PSMA PET/CT in bone metastases from prostate cancer following treatment with radium-223 as a surrogate marker for tumor cell killing.

Conditions

Prostate Cancer

Keywords

PSMA

Outcome Measures

Primary Outcomes (1)

• SUV-max

  fractional decline of intensity of tracer uptake measured by SUVmax on 68Ga-PSMA PET/CT

  6 months

Study Arms (1)

Radium-223

EXPERIMENTAL

Drug: radium-223 dichloride

Interventions

radium-223 dichloride DRUG

6 doses of Radium-223

Radium-223

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: male only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Resident of Canada
• Male sex
• Age 18 years or older
• Progressive (symptoms, conventional imaging, PSA, bone scan, FCH PET/CT or other) castration-resistant prostate cancer in the judgment of the treating physician without change in systemic anti-neoplastic therapy since documented progression
• Six or greater bone metastases robustly-avid on recent (4 weeks) MDP or NaF scintigraphy
• Recently failed (within 3 months) or failing novel androgen receptor pathway inhibitors (abiraterone + prednisone or enzalutamide) with intention of continuing the drug for at least 7 months OR minimum 14 day washout period from either agent prior to study enrollment
• No known visceral metastases or adenopathy greater than 3 cm short axis on conventional imaging
• Not received docetaxel for castration-resistant disease
• ECOG performance status 0 - 2, inclusive
• Life expectancy of greater than 6 months
• Serum testosterone less than or equal to 50 ng/dl
• Hemoglobin greater than or equal to 100 g/L with no blood transfusions or EPO in preceding 3 weeks
• Neutrophils greater than or equal to 1.5 x109/L
• Platelets greater than or equal to 100 x109/L
• No prior hemi-body radiotherapy

You may not qualify if:

• Planned change in systemic anti-neoplastic therapy during the approximately 7 month trial
• Unable to tolerate the physical/logistical requirements of a PET/CT scan including lying supine for up to 30 minutes with the arms above the head and tolerating intravenous cannulation for injection of the study drug.
• Medically unstable patients (e.g. acute cardiac or respiratory distress or hypotensive, etc.)
• Patients who exceed the safe weight limit of the PET/CT bed (approximately 400 lbs.) or who cannot fit through the PET/CT bore (70 cm diameter)
• Patients who are claustrophobic

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

radium Ra 223 dichloride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Nuclear Medicine

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: February 23, 2017
• Study Start: March 22, 2018
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

CA (1)