Actively Recruiting
Targeted Radionuclide Therapy in Metastatic Prostate Cancer Using a New PSMA Ligand Radiolabelled With Terbium-161 (161Tb-SibuDAB) - Dose Identification/Escalation Phase Ia/b Study
Led by University Hospital, Basel, Switzerland · Updated on 2024-08-14
25
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers will test a new treatment for prostate cancer. This treatment uses an antibody tagged with a small amount of radioactive material. Researchers believe the new antibody might work better than those used before. In the first part of the study researchers will compare the new treatment to the old one on prostate cancer patients using very low doses, not strong enough to treat nor to cause strong adverse reactions. Each patient will eventually receive both treatments, but one at a time. The aim of the second part of the study is to find the best dose of the new treatment for patients. This means finding the dose that offers the most benefits with the fewest side effects. The performance of different prostate cancer diagnostic methods is also in scope of the study.
CONDITIONS
Official Title
Targeted Radionuclide Therapy in Metastatic Prostate Cancer Using a New PSMA Ligand Radiolabelled With Terbium-161 (161Tb-SibuDAB) - Dose Identification/Escalation Phase Ia/b Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed consent form
- Male patients older than 18 years
- Diagnosis of progressive PSMA-positive metastatic castration-resistant prostate cancer after prior therapies or unfit for chemotherapy
- Currently under active 177Lu-PSMA-I&T therapy having completed first two treatment cycles (for Phase Ia)
- At least 3 measurable tumors over 1.5 cm with strong PSMA uptake (SUVmax > 20) on PET/CT
- ECOG performance status of 0 or 1
- Blood counts: leucocytes ≥ 3 G/L, hemoglobin ≥ 100 g/L, thrombocytes ≥ 100 G/L
- Estimated glomerular filtration rate (eGFR) above 45 ml/min
- Albumin level above 25 g/L
- Liver enzymes (ALT, AST, AP) no more than 5 times the upper standard value
- Bilirubin not exceeding twice the upper standard value
- Male patients not surgically sterilized must use effective contraception during and for 4 months after treatment
You will not qualify if you...
- Prior PSMA-targeted radioligand therapy except first two cycles in Phase Ia
- PSMA-negative or PSMA-negative/FDG-positive disease
- Known allergy or intolerance to DOTA, DOTAGA, urea-based analogues, or components of 177Lu-PSMA-I&T or 161Tb-SibuDAB
- Active infection at screening or serious infection in past 4 weeks
- Use of other investigational drugs within 60 days prior to study start
- Therapeutic radiopharmaceutical treatment planned or given within 8 half-lives of radionuclide
- Extensive bone marrow radiotherapy within 3 months before study
- Chemotherapy within 4 weeks before study
- Uncontrolled significant medical, psychiatric, or surgical conditions that could affect safety or study compliance
- Mental conditions preventing informed consent or cooperation
- History of other cancers within 5 years except fully removed non-melanoma skin cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
Research Team
D
Damian Wild, MD
CONTACT
A
Alin Chirindel, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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