Actively Recruiting
EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T
Led by Peter MacCallum Cancer Centre, Australia · Updated on 2025-04-06
42
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial will evaluate the safety and efficacy of \[161Tb\]Tb -PSMA-I\&T in men with metastatic castration-resistant prostate cancer (mCRPC).
CONDITIONS
Official Title
EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 18 years or older
- Confirmed adenocarcinoma of the prostate or clear diagnosis of metastatic prostate cancer with elevated PSA
- ECOG performance status of 2 or less
- Prior treatment with at least one line of taxane chemotherapy, unless medically unsuitable
- Prior treatment with at least one second-generation androgen receptor-targeted agent
- Progressive disease as defined by specific PSA, soft tissue, or bone progression criteria
- Prior surgical orchiectomy or ongoing chemical castration with LHRH analogue
- Serum testosterone levels at or below 1.75 nmol/L (50 ng/dL)
- Significant PSMA uptake on PET/CT scan meeting defined SUVmax criteria
- Life expectancy of 6 months or more
- Adequate bone marrow, liver, and kidney function based on specified laboratory values
- Willingness to use barrier contraception if sexually active
- Ability and willingness to comply with all study requirements
- At least 3 weeks since last surgery or radiotherapy before registration
You will not qualify if you...
- Previous treatment with other radioisotopes such as PSMA radioligands or radium-223
- Presence of discordant disease sites on PET imaging (FDG-positive with low PSMA uptake)
- Other cancers within the past 2 years except certain skin cancers or those unlikely to recur within 24 months
- Symptomatic brain or leptomeningeal metastases
- Symptomatic or impending spinal cord compression unless treated and stable for over 4 weeks
- Concurrent severe illness or infection that would risk safety during study procedures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
Research Team
J
James Butaeu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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