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Radioisotope Therapy
177Lu-rhPSMA-10.1 for Prostate Cancer
Phase 1 & 2
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
Positive disease expression of PSMA as confirmed on PSMA PET/CT scan
At least 4 weeks or 5 half-lives (whichever is longer) elapsed between last anti-cancer treatment administration and the initiation of study treatment (except for Luteinising Hormone-releasing Hormone or GnRH)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weekly intervals
Awards & highlights
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.
Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to hormone therapy and has spread, who are in fairly good health (able to perform daily activities) with a life expectancy of at least 6 months. They must have had no recent major surgeries or other cancer treatments, and their cancer should be visible on scans and produce a specific protein seen on PET/CT scans.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of an injection called 177Lu-rhPSMA-10.1 for men whose prostate cancer can be seen on certain scans and continues to grow despite hormone therapy. The study will also determine the right dose and measure how the body processes the drug.See study design
What are the potential side effects?
Possible side effects may include allergic reactions to ingredients in the treatment, kidney problems if there's pre-existing damage or obstruction, blood count changes due to bone marrow involvement by disease or treatment, heart issues detectable on ECGs, or worsening urinary issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer shows positive for PSMA on scans.
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It's been over 4 weeks or 5 half-lives since my last cancer treatment, except for hormone therapy.
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My testosterone levels are low due to treatment.
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I can care for myself and doctors expect me to live 6 months or more.
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I am a man over 18 with confirmed prostate cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks post final imp
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks post final imp
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1 Frequency and nature of TEAEs
Phase 1 Incidence of DLTs
Phase 2, anti-tumour response
Trial Design
4Treatment groups
Experimental Treatment
Group I: Phase 2, Cohort 2, Taxane-naïve mCRPCExperimental Treatment2 Interventions
Subjects with PSMA positive disease will receive up to 6 cycles of the Therapeutic IMP at the Recommended Phase 2 dose [RP2D] .
Group II: Phase 2, Cohort 1, post-chemotherapy mCRPCExperimental Treatment2 Interventions
Subjects with PSMA positive disease will receive up to 6 cycles of the Therapeutic IMP at the Recommended Phase 2 dose [RP2D]
Group III: Phase 1, Cohort BExperimental Treatment2 Interventions
Subjects with PSMA positive disease will receive 7.4GBq of 177Lu-rhPSMA-10.1 (maximum of 3 cycles).
Group IV: Phase 1, Cohort AExperimental Treatment2 Interventions
Subjects with PSMA positive disease will receive 5.55GBq of 177Lu-rhPSMA-10.1 (maximum of 3 cycles).
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Who is running the clinical trial?
Blue Earth Therapeutics LtdLead Sponsor
PSI CROIndustry Sponsor
6 Previous Clinical Trials
2,108 Total Patients Enrolled
Blue Earth TherapeuticsStudy DirectorBlue Earth Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer shows positive for PSMA on scans.My side effects from previous treatments are mild, except for possible hair loss and some nerve issues or increased need to urinate.I have severe issues controlling my bladder that could make handling radioactive urine unsafe.My blood tests show my organs and bone marrow are working well.I have one kidney, a kidney transplant, or am on medication that could harm my kidneys.I have had specific radiation treatments for my cancer.I don't have any health issues that would make it unsafe for me to join the study.I am experiencing symptoms or have been diagnosed with potential spinal cord compression.My side effects from previous treatments are mild, except for possible hair loss and some nerve issues or increased need to urinate.My scans show cancer that does not show up on PSMA tests.My cancer shows positive for PSMA on scans.I have a blockage in my urinary tract that hasn't been fixed.I am currently receiving bisphosphonates for bone treatment.I have another type of cancer that might affect my life expectancy or interfere with this study.It's been over 4 weeks or 5 half-lives since my last cancer treatment, except for hormone therapy.It's been over 4 weeks or 5 half-lives since my last cancer treatment, except for hormone therapy.I have metallic implants that could interfere with medical imaging.My scans show cancer lesions and were done within the last 28 days.My prostate cancer shows neuroendocrine features.I have a history of blood cancer.My bone scan shows widespread cancer spread in the marrow.I have a history of cancer spreading to my brain or spinal cord.My testosterone levels are low due to treatment.I've had radiation therapy that affected over 30% of my bone marrow or kidneys.I can care for myself and doctors expect me to live 6 months or more.I am a man over 18 with confirmed prostate cancer.It has been over 12 weeks since my last major surgery.I am a man over 18 with confirmed prostate cancer.I can care for myself and doctors expect me to live 6 months or more.My testosterone levels are low due to treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2, Cohort 1, post-chemotherapy mCRPC
- Group 2: Phase 1, Cohort B
- Group 3: Phase 1, Cohort A
- Group 4: Phase 2, Cohort 2, Taxane-naïve mCRPC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What site did they apply to?
Advanced Molecular Imaging and Therapy
What portion of applicants met pre-screening criteria?
Did not meet criteria
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