PSMA PET/CT guided intensification of therapy for Prostate Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Prostate CancerPSMA PET/CT guided intensification of therapy - DiagnosticTest
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial will study whether using PSMA PET/CT to guide treatment for high-risk prostate cancer results in better outcomes than using conventional imaging.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 5 years

3 years
Impact of PMSA PET/CT on RT or surgical management (rate of treatment intensification)
New lesion detection yield (on PSMA PET/CT)
5 years
Cost-effectiveness (EQ5D5L)
Quality of Life (EPIC 26)
Rates of toxicity (CTCAE)
Time to subsequent next-line therapy
To determine if PSMA PET/CT guided intensification of therapy is superior to standard of care (SOC) therapy as measured by improved failure-free survival (FFS).

Trial Safety

Safety Progress

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

Trial Design

2 Treatment Groups

Control - SOC Treatment
1 of 2
Experimental - PSMAiTx
1 of 2

Active Control

Experimental Treatment

776 Total Participants · 2 Treatment Groups

Primary Treatment: PSMA PET/CT guided intensification of therapy · No Placebo Group · Phase 3

Experimental - PSMAiTx
DiagnosticTest
Experimental Group · 1 Intervention: PSMA PET/CT guided intensification of therapy · Intervention Types: DiagnosticTest
Control - SOC Treatment
Other
ActiveComparator Group · 1 Intervention: Control Arm · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

London Health Sciences CentreOTHER
136 Previous Clinical Trials
46,905 Total Patients Enrolled
1 Trials studying Prostate Cancer
52 Patients Enrolled for Prostate Cancer
Queen's UniversityOTHER
336 Previous Clinical Trials
110,172 Total Patients Enrolled
2 Trials studying Prostate Cancer
80 Patients Enrolled for Prostate Cancer
Princess Margaret Hospital, CanadaOTHER
114 Previous Clinical Trials
29,312 Total Patients Enrolled
7 Trials studying Prostate Cancer
740 Patients Enrolled for Prostate Cancer
British Columbia Cancer AgencyOTHER
163 Previous Clinical Trials
89,354 Total Patients Enrolled
23 Trials studying Prostate Cancer
5,154 Patients Enrolled for Prostate Cancer
Kingston Health Sciences CentreOTHER
31 Previous Clinical Trials
33,891 Total Patients Enrolled
Tom Baker Cancer CentreOTHER
24 Previous Clinical Trials
7,093 Total Patients Enrolled
3 Trials studying Prostate Cancer
155 Patients Enrolled for Prostate Cancer
McMaster UniversityOTHER
801 Previous Clinical Trials
1,727,101 Total Patients Enrolled
4 Trials studying Prostate Cancer
6,349 Patients Enrolled for Prostate Cancer
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
326 Previous Clinical Trials
110,963 Total Patients Enrolled
4 Trials studying Prostate Cancer
1,309 Patients Enrolled for Prostate Cancer
Canadian Cancer Society (CCS)OTHER
71 Previous Clinical Trials
30,123 Total Patients Enrolled
6 Trials studying Prostate Cancer
881 Patients Enrolled for Prostate Cancer
Lantheus Medical ImagingIndustry Sponsor
50 Previous Clinical Trials
4,331,107 Total Patients Enrolled
1 Trials studying Prostate Cancer
9 Patients Enrolled for Prostate Cancer
Institute of Health Economics, CanadaOTHER
8 Previous Clinical Trials
2,503 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have prostate cancer and are aged 18 years or older.
You have a performance status of 2 or less.
You must provide informed consent prior to study entry.
You have a prior history of radical prostatectomy and biochemical failure (PSA>0.1ng/mL).

Who else is applying?

What state do they live in?
New York100.0%
What site did they apply to?
London Health Sciences Centre100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
How many prior treatments have patients received?
0100.0%