NCT02826382

Brief Summary

A phase1 study to demonstrate \[68Ga\]P15-041 binding to bone metastases in prostate cancer and determination of human dosimetry.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at P25-P50 for early_phase_1 prostate-cancer

Timeline
Completed

Started Sep 2016

Longer than P75 for early_phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 20, 2016

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

6.3 years

First QC Date

July 5, 2016

Last Update Submit

January 10, 2023

Conditions

Prostate CancerBone Metastases

Outcome Measures

Primary Outcomes (2)

  • Time course of uptake of [68Ga]P15-041 in bone metastases

    kinetics of \[68Ga\]P15-041 uptake in known or suspected bone metastases in prostate cancer

    60 minutes post injection

  • Time course of whole body distribution of [68Ga]P15-041

    whole body distribution of \[68Ga\]P15-041 used for human dosimetry determination

    3 hours post injection

Study Arms (2)

Dynamic imaging group

EXPERIMENTAL

Dynamic imaging of suspected bone metastases with the investigation drug \[68Ga\]P15-041

Drug: [68Ga]P15-041

Whole body dosimetry group

EXPERIMENTAL

Determination of human dosimetry of the investigation drug \[68Ga\]P15-041

Drug: [68Ga]P15-041

Interventions

[68Ga]P15-041DRUG

Imaging by Positron Emission Tomography after injection of \[68Ga\]P15-041

Dynamic imaging groupWhole body dosimetry group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed prostate cancer. known or suspected bone metastases referred for a clinical \[99mTc\]MDP scan

You may not qualify if:

  • Estimated creatinine clearance (GFR) \< 30 mL/min (calculated), history of hyperparathyroidism, • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician, • Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2016

First Posted

July 11, 2016

Study Start

September 20, 2016

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

January 12, 2023

Record last verified: 2023-01

Locations

US(1)