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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03062254
• Other study ID #: 17-029
• Status: Completed
• Phase: Phase 2
• Start date: March 22, 2018
• Est. completion date: July 15, 2021

Study information

• Verified date: September 2021
• Source: Sir Mortimer B. Davis - Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria

• 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

• No impending or established spinal cord compression

• No unmanageable fecal incontinence

• Patient has good IV access

• Able to understand and provide written informed consent

Exclusion Criteria

• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• radium-223 dichloride
6 doses of Radium-223

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Sir Mortimer B. Davis - Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SUV-max	fractional decline of intensity of tracer uptake measured by SUVmax on 68Ga-PSMA PET/CT	6 months