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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radium-223 dichloride

Drug

6 doses of Radium-223

Primary outcomes

SUV-max

Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2021
First posted: Feb 23, 2017
Registry last updated: Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed