Metabolic Change in Prostate Cancer Bone Metastases on 68... | NCT03062254

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

NCT03062254

Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Status

Completed

Last Update Posted

Sep 21, 2021Actual

Enrollment

14Actual

Phase

Phase 2

Conditions

Prostate Cancer

Interventions

radium-223 dichloride

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 22, 2018Actual

Primary Completion Date

Jul 15, 2020Actual

Completion Date

Jul 15, 2021Actual

First Submitted Date

Feb 20, 2017

First Submission Date that Met QC Criteria

Feb 22, 2017

First Posted Date

Feb 23, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2021

Last Update Posted Date

Sep 21, 2021Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Label	Type	Description	Intervention Names
Radium-223	Experimental		Drug: radium-223 dichloride

Name	Type	Description	Arm Group Labels	Other Names
radium-223 dichloride	Drug	6 doses of Radium-223	Radium-223

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

male only

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms