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177Lu-rhPSMA-10.1 injection for Metastatic Castration Resistant Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
XCancer Omaha / Urology Cancer Center, Omaha, NEMetastatic Castration Resistant Prostate Cancer+5 More177Lu-rhPSMA-10.1 injection - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is testing a new treatment for prostate cancer that has spread and is resistant to hormone therapy. They are testing how well it works and how safe it is.

Eligible Conditions
  • Metastatic Castration Resistant Prostate Cancer
  • Prostate Cancer
  • Urogenital Neoplasms
  • Prostate Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Dose Escalation

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: 12 weekly intervals

12 weekly intervals
Phase 2, anti-tumour response
Week 6
Phase 1 Incidence of DLTs
End of study
Phase 1 Frequency and nature of TEAEs

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
AC176
1
TNB-585
1
Dose Escalation

Trial Design

4 Treatment Groups

Phase 1, Cohort A
1 of 4
Phase 1, Cohort B
1 of 4
Phase 2, Cohort 1, post-chemotherapy mCRPC
1 of 4
Phase 2, Cohort 2, Taxane-naïve mCRPC
1 of 4

Experimental Treatment

150 Total Participants · 4 Treatment Groups

Primary Treatment: 177Lu-rhPSMA-10.1 injection · No Placebo Group · Phase 1 & 2

Phase 1, Cohort AExperimental Group · 2 Interventions: 177Lu-rhPSMA-10.1 injection, 18F-rhPSMA-7.3 injection · Intervention Types: Drug, DiagnosticTest
Phase 1, Cohort BExperimental Group · 2 Interventions: 177Lu-rhPSMA-10.1 injection, 18F-rhPSMA-7.3 injection · Intervention Types: Drug, DiagnosticTest
Phase 2, Cohort 1, post-chemotherapy mCRPCExperimental Group · 2 Interventions: 177Lu-rhPSMA-10.1 injection, 18F-rhPSMA-7.3 injection · Intervention Types: Drug, DiagnosticTest
Phase 2, Cohort 2, Taxane-naïve mCRPCExperimental Group · 2 Interventions: 177Lu-rhPSMA-10.1 injection, 18F-rhPSMA-7.3 injection · Intervention Types: Drug, DiagnosticTest

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weekly intervals

Who is running the clinical trial?

Blue Earth Therapeutics LtdLead Sponsor
PSI CROIndustry Sponsor
6 Previous Clinical Trials
2,046 Total Patients Enrolled
Blue Earth TherapeuticsStudy DirectorBlue Earth Therapeutics

Eligibility Criteria

Age 18+ · Male Participants · 12 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have advanced prostate cancer that has not been treated with taxane in the past.

Who else is applying?

What site did they apply to?
Advanced Molecular Imaging and Therapy100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References

Frequently Asked Questions

Is this research currently open to enrollment?

"Clinicaltrials.gov reports that this clinical trial is now open to participants; it was initially posted on the 20th of July 2022 and updated most recently on the 26th of July 2022." - Anonymous Online Contributor

Unverified Answer

To what extent is enrollment in this clinical trial being maximized?

"Affirmative, the information available on clinicaltrials.gov exhibits that this medical trial is presently recruiting patients. The initial advertisement for participation was posted on July 20th 2022 and has been updated as recently as July 26th 2022 – 150 individuals are expected from 1 research hub." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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