RecruitingProstate CancerMetastatic Castration-resistant Prostate CancermCRPC
Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection
Eligible age
18+ yrs
Accepts
Men
Locations
4 states
Healthy volunteers
No
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About this study
To determine the dose, safety, radiation dosimetry and efficacy of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.
Sponsor: Blue Earth Therapeutics Ltd
You may qualify if…
- ✓ 1. Male subjects, 18 years of age or older with histologically confirmed adenocarcinoma of the prostate.
- ✓ 2. Serum testosterone levels \<50 ng/dL (1.73 nmol/L) after surgical or continued chemical castration.
- ✓ 3. Presence of disease target or non target lesions (per RECIST v1.1) on CT/MRI and/or presence of disease on full body 99mTc bone scan performed within 28 days of screening.
- ✓ 4. Positive disease expression of PSMA as confirmed on PSMA PET/CT scan.
- ✓ 5. 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).
- ✓ 6. Resolution of all previous treatment related toxicities to CTCAE version 5.0 grade of ≤1 (except for chemotherapy induced alopecia and grade 2 peripheral neuropathy or grade 2 urinary frequency which are allowed).
- ✓ 7. Prior major surgery must be at least 12 weeks prior to study entry.
- ✓ 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 with a life expectancy ≥6 months.
You may not qualify if…
- ✕ 1. Known hypersensitivity to the therapeutic or diagnostic IMP or any of its constituents.
- ✕ 2. Presence of significant PSMA-negative disease on ceCT/MRI scan
- ✕ 3. Diffuse marrow infiltration of disease ('superscan' appearance on full body 99mTc bone scan).
- ✕ 4. Symptomatic spinal cord compression, or clinical or radiological findings that are indicative of impending spinal cord compression.
- ✕ 5. Known history of haematological malignancy.
- ✕ 6. Known history of central nervous system (CNS) metastases.
- ✕ 7. Histological findings consistent with neuroendocrine phenotype of prostate cancer.
- ✕ 8. Known history of other solid malignancy that may reduce life expectancy and/or may interfere with disease assessment.
Where it's recruiting
Source: ClinicalTrials.gov · NCT05413850 · last updated 2026-05-14