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[68Ga]P15-041 for Prostate Cancer

Q: Is this research initiative still accepting participants?

<p>Affirmative. As indicated by clinicaltrials.gov, this medical trial is currently seeking new patients to enroll. The study was originally posted on September 20th 2016 and most recently edited on April 29th 2022.</p>

Q: What is the enrolment capacity for this trial?

<p>Affirmative. According to the available clinicaltrials.gov data, this trial initiated on September 20th 2016 and was last modified on April 29th 2022 is actively recruiting patients for its cohort of 30 participants that will be administered at a single location.</p>

Phase < 1

Waitlist Available

Research Sponsored by Five Eleven Pharma, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 minutes post injection

Awards & highlights

Study Summary

This trial will test if a new imaging agent can help doctors better visualize and target prostate cancer that has spread to the bone.

Eligible Conditions

Prostate Cancer
Bone Metastases

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 minutes post injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 minutes post injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 minutes post injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Whole body dosimetry groupExperimental Treatment1 Intervention

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

Group II: Dynamic imaging groupExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

[68Ga]P15-041

2016

Completed Early Phase 1

~20

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Five Eleven Pharma, Inc.Lead Sponsor

5 Previous Clinical Trials

396 Total Patients Enrolled

3 Trials studying Prostate Cancer

378 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research initiative still accepting participants?

"Affirmative. As indicated by clinicaltrials.gov, this medical trial is currently seeking new patients to enroll. The study was originally posted on September 20th 2016 and most recently edited on April 29th 2022."

Answered by AI

What is the enrolment capacity for this trial?

"Affirmative. According to the available clinicaltrials.gov data, this trial initiated on September 20th 2016 and was last modified on April 29th 2022 is actively recruiting patients for its cohort of 30 participants that will be administered at a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Preliminary Evaluation of Uptake in Bone Metastases and Biodistribution of [68Ga]P15-041

2016. "Preliminary Evaluation of Uptake in Bone Metastases and Biodistribution of [68Ga]P15-041". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02826382.