Actively Recruiting
Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection
Led by Blue Earth Therapeutics Ltd · Updated on 2026-05-14
82
Participants Needed
21
Research Sites
297 weeks
Total Duration
On this page
Sponsors
B
Blue Earth Therapeutics Ltd
Lead Sponsor
P
PSI CRO
Collaborating Sponsor
AI-Summary
What this Trial Is About
To determine the dose, safety, radiation dosimetry and efficacy of 177Lu-rhPSMA-10.1 in participants with PSMA-expressing metastatic castrate resistant prostate cancer.
CONDITIONS
Official Title
Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male 18 years or older with confirmed prostate adenocarcinoma
- Serum testosterone below 50 ng/dL after surgical or chemical castration
- Presence of disease lesions on CT/MRI or bone scan within 28 days
- Positive PSMA expression confirmed by PSMA PET/CT scan
- At least 4 weeks or 5 half-lives since last anti-cancer treatment (except hormone therapy)
- Previous treatment-related side effects resolved to mild or less (grade 61)
- Major surgery completed at least 12 weeks before study start
- ECOG performance status 0-2 with life expectancy of 6 months or more
- Adequate bone marrow and organ function by blood tests
- Use of adequate contraception by patients and partners
- Phase 1: progressed after at least 1 novel androgen drug and 1-2 taxane chemotherapy courses
- Phase 2: progressed after at least 1 novel androgen drug but no prior taxane chemotherapy
You will not qualify if you...
- Allergy to study drug or diagnostic agents
- Significant PSMA-negative disease on CT/MRI
- Diffuse bone marrow involvement on bone scan
- Symptomatic or impending spinal cord compression
- History of blood cancers or CNS metastases
- Neuroendocrine prostate cancer diagnosis
- Other cancers that could affect survival or assessment
- Unresolved urinary tract obstruction
- Uncontrolled medical, psychiatric, or surgical conditions
- Current bisphosphonate treatment for bone disease
- Severe urinary incontinence
- Single kidney, kidney transplant, or high risk of kidney toxicity
- Abnormal ECG at screening
- Past radiation involving >30% of bone marrow or kidneys
- Prior treatments with certain radionuclide therapies or hemi-body irradiation
- Bilateral hip replacements or metal implants affecting imaging
- Blood transfusions only to meet study criteria
- Participation in other IMP studies within 28 days
- History of serious lung disease
- Prior thoracic radiation therapy
- Abnormal PSMA uptake in lung above normal levels
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
Biogenix Molecular LLC
Miami, Florida, United States, 33165
Actively Recruiting
2
NovaCure Health
Miami, Florida, United States, 33176
Actively Recruiting
3
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
XCancer Omaha / Urology Cancer Center
Omaha, Nebraska, United States, 68130
Actively Recruiting
5
Weill Cornell Medicine - New York - Presbyterian Hospital
New York, New York, United States, 10065
Completed
6
Saint Luc University Hospital
Brussels, Belgium, 1200
Actively Recruiting
7
University Hospital Ghent
Ghent, Belgium, 9000
Actively Recruiting
8
University Hospital Leuven
Leuven, Belgium
Actively Recruiting
9
University Hospital Aachen
Aachen, Germany
Actively Recruiting
10
Universitätsklinikum Augsburg
Augsburg, Germany
Actively Recruiting
11
University Hospital Essen
Essen, Germany
Actively Recruiting
12
Hospital Rechts der Isar
Munich, Germany
Actively Recruiting
13
Radboud UMC
Nijmegen, Gelderland, Netherlands, 6525GA
Actively Recruiting
14
Meander Medisch Centrum
Amersfoort, Netherlands
Actively Recruiting
15
Bristol Hematology and Oncology Center
Bristol, United Kingdom, BS2 8ED
Actively Recruiting
16
Beatson West of Scotland Cancer Center
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
17
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Actively Recruiting
18
James Cook University Hospital
Middlesbrough, United Kingdom, TS4 3BW
Actively Recruiting
19
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
Actively Recruiting
20
Weston Park
Sheffield, United Kingdom
Actively Recruiting
21
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
B
Blue Earth Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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