Lu-177-PSMA-I&T for Prostate Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Prostate Cancer+2 More
Lu-177-PSMA-I&T - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is comparing the safety and efficacy of 177Lu-PSMA-I&T (a treatment for prostate cancer) to hormone therapy.

Eligible Conditions
  • Prostate Cancer
  • Malignant Neoplasms

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 156 weeks

156 weeks
Overall Survival (OS)
PSA50 Response Rate
Progression Free Survival
Second Progression-Free Survival
Second Radiographic Progression Free Survival (rPFS 2)
Time to Chemotherapy (TTC)
Time to First Symptomatic Skeletal Event (SSE)
Time to Soft Tissue Progression (STP)
22 weeks
Quality of Life Questionnaire- EORTC QLQ-C30
34 weeks
Radiographic Progression Free Survival

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Standard Of Care Hormone Therapy
1 of 2
Investigational Drug
1 of 2

Active Control

Experimental Treatment

400 Total Participants · 2 Treatment Groups

Primary Treatment: Lu-177-PSMA-I&T · No Placebo Group · Phase 3

Investigational Drug
Drug
Experimental Group · 1 Intervention: Lu-177-PSMA-I&T · Intervention Types: Drug
Standard Of Care Hormone Therapy
Drug
ActiveComparator Group · 1 Intervention: Abiraterone with Prednisone or Enzalutamide · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 156 weeks

Who is running the clinical trial?

Curium US LLCLead Sponsor
1 Previous Clinical Trials

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The tumor must be a prostatic adenocarcinoma without predominant small cell component.
You have a measurable disease or two new bone lesions.
The patient has a positive (i.e., abnormal) PSMA-PET scan.
You have received no more than one previous AR-directed therapy.
You have a serum/plasma PSA level of 2 ng/mL or greater.
You are castrated with a serum testosterone level of <50 ng/dL.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: November 19th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
California100.0%
How old are they?
65+50.0%
18 - 6550.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
What site did they apply to?
M Health Fairview Ridges Cancer Clinic100.0%
Why did patients apply to this trial?
  • "Diagnosed with very high risk, locally advanced high grade prostate cancer (Gleason Score 9). Currently on ADT. Starting 5-1/2 weeks of EBT on December 28."
How many prior treatments have patients received?
0100.0%