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Radioisotope Therapy
Lutetium Treatments for Prostate Cancer
Phase < 1
Recruiting
Research Sponsored by Blue Earth Therapeutics Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient has non-curative PSMA-positive prostate cancer that has spread outside of the prostate gland and is undergoing or being planned for radioligand therapy
At least 1 PSMA-positive lesion that can be outlined on PET or CT and ≥1 cm in the short axis measured on either modality, for the purpose of dosimetry
Must not have
Any change to prostate cancer medication or new prostate cancer therapy, prostate cancer surgical procedure within 42 days prior to screening or during the study
Previous treatment with any radiopharmaceutical therapy in the 42 days or 5 half-lives prior to Visit 1 (Screening)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial compares two different treatments for advanced prostate cancer using imaging and dosimetry techniques.
Who is the study for?
This trial is for men over 60 with non-curative metastatic prostate cancer that shows up on PET or CT scans. They must have good blood counts, liver function, and kidney health. Participants need to consent to study procedures and be planned for radioligand therapy.
What is being tested?
The study compares two radioactive drugs: lutetium (177Lu) rhPSMA 10.1 and Pluvicto® in a crossover design, meaning patients will receive both treatments at different times to measure which one works better for their prostate cancer.
What are the potential side effects?
Possible side effects of the radioactive treatments include nausea, fatigue, dry mouth or changes in taste, low blood cell counts increasing infection risk or bleeding problems, and potential kidney or liver issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer cannot be cured, has spread, and I am getting or planning to get radioligand therapy.
Select...
I have a tumor larger than 1 cm that shows up on PET or CT scans.
Select...
I am a man aged 60 or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't changed my prostate cancer treatment or had surgery in the last 42 days.
Select...
I haven't had radiopharmaceutical therapy in the last 42 days.
Select...
I haven't taken part in other drug trials within the last 42 days or longer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Sequence BExperimental Treatment1 Intervention
Patients in Sequence B will receive lutetium (177Lu) vipivotide tetraxetan followed by lutetium (177Lu) rhPSMA 10.1
Group II: Sequence AExperimental Treatment1 Intervention
Patients in Sequence A will receive lutetium (177Lu) rhPSMA 10.1 followed by lutetium (177Lu) vipivotide tetraxetan
Find a Location
Who is running the clinical trial?
Blue Earth Therapeutics LtdLead Sponsor
1 Previous Clinical Trials
150 Total Patients Enrolled
1 Trials studying Prostate Cancer
150 Patients Enrolled for Prostate Cancer
Medpace, Inc.Industry Sponsor
96 Previous Clinical Trials
29,853 Total Patients Enrolled
Blue Earth TherapeuticsStudy DirectorBlue Earth Therapeutics
1 Previous Clinical Trials
150 Total Patients Enrolled
1 Trials studying Prostate Cancer
150 Patients Enrolled for Prostate Cancer