177Lu-PSMA-617 for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
CHUM-Centre Hospitalier de l'Universite de Montreal, Montreal, CanadaProstate Cancer177Lu-PSMA-617 - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is testing a new therapy that uses high doses of radiation to target prostate cancer. They want to see if it's more effective than chemotherapy.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: 3 years

3 years
Adverse event (AE) profile (CTCAE v5.0)
Clinical benefit rate (CBR) > 24 weeks (RECIST v1.1).
Overall Survival
Progression-free survival
Proportions of patients with decreased PSA from baseline and the magnitude of change
Response duration including partial response, complete response or stable disease > 24 (RECIST v1.1)
Second rPFS in patients who meet the criteria for rPFS and cross over to the alternate therapy
Time to commencement of third line therapy
6 months
Progression-free survival rate at 6 months defined by PCWG 3
Progression-free survival rate at 6 months defined by PSA
Progression-free survival rate at 6 months defined by RECIST 1.1

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Docetaxel
1 of 2
177 Lu-PSMA-617
1 of 2

Active Control

Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: 177Lu-PSMA-617 · No Placebo Group · Phase 2

177 Lu-PSMA-617
Drug
Experimental Group · 1 Intervention: 177Lu-PSMA-617 · Intervention Types: Drug
Docetaxel
Drug
ActiveComparator Group · 1 Intervention: Docetaxel · Intervention Types: Drug

Trial Logistics

Trial Timeline

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

Who is running the clinical trial?

Canadian Cancer Trials GroupLead Sponsor
116 Previous Clinical Trials
65,642 Total Patients Enrolled
9 Trials studying Prostate Cancer
6,625 Patients Enrolled for Prostate Cancer
Prostate Cancer CanadaOTHER
9 Previous Clinical Trials
7,458 Total Patients Enrolled
6 Trials studying Prostate Cancer
7,214 Patients Enrolled for Prostate Cancer
EndocyteIndustry Sponsor
35 Previous Clinical Trials
3,094 Total Patients Enrolled
3 Trials studying Prostate Cancer
1,072 Patients Enrolled for Prostate Cancer
Kim ChiStudy ChairBCCA - Vancouver Cancer Centre, BC Canada
4 Previous Clinical Trials
710 Total Patients Enrolled
3 Trials studying Prostate Cancer
687 Patients Enrolled for Prostate Cancer
Francois BenardStudy ChairBCCA - Vancouver Cancer Centre, BC Canada
1 Previous Clinical Trials
50 Total Patients Enrolled
Fred SaadStudy ChairCHUM-Centre Hospitalier de l'Universite de Montreal, Canada
1 Previous Clinical Trials
866 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 9 Total Inclusion Criteria

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Frequently Asked Questions

Is 177Lu-PSMA-617 a new experimental treatment?

"There are 337 different medical studies currently underway that involve 177Lu-PSMA-617. Most of these trials are in their third phase, with 132 total. The vast majority of these clinical trials are taking place in Fuzhou, Fujian; however, there are over 23000 other locations where similar research is being conducted." - Anonymous Online Contributor

Unverified Answer

To what conditions or diseases is 177Lu-PSMA-617 commonly applied?

"177Lu-PSMA-617 can be used to fight against malignant neoplasms, sarcoma, and in some cases where patients have issued advance directives." - Anonymous Online Contributor

Unverified Answer

When will 177Lu-PSMA-617 be cleared by the FDA?

"The lack of data regarding 177Lu-PSMA-617's efficacy results in it receiving a 2 for safety." - Anonymous Online Contributor

Unverified Answer

At how many facilities is this trial currently underway?

"5 sites are presently running this trial, with locations in Vancouver, Montreal and Quebec City among others. If you enroll in the trial, it is best to choose a site closest to your location to minimize travel demands." - Anonymous Online Contributor

Unverified Answer

How many subjects are being observed in this trial?

"That is correct. Currently, the online information hosted on clinicaltrials.gov says that this study is looking for more participants. The trial was created on December 17th 2020 and was last edited October 17th of this year. They are recruiting 200 individuals from 5 different locations." - Anonymous Online Contributor

Unverified Answer

Are we looking for more test subjects for this experiment?

"That is accurate. The clinicaltrials.gov website indicates that this study, which was established on December 17th 2020, is currently looking for 200 participants at 5 different medical centres." - 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.