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

Recruiting now · Phase 1

Conditions studied: Castration-resistant Prostate Cancer

In brief

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.

Key facts

Study ID: NCT06343038
Run by: University Hospital, Basel, Switzerland
People needed: 25
Starts: 2024-02-20
Expected to finish: 2028-06-01
Last updated by the study team: 2024-08-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Consent form signed
Male patients with age > 18 years
Clinical indication for RLT with 177Lu-PSMA-I\&T (progressive PSMA-positive mCRPC patients after androgen receptor signalling pathway inhibitor and taxan-based chemotherapy or patient unfit for chemotherapy)
Patients will be included in Phase Ia while being under active therapy with 177Lu-PSMA-I\&T (SoC) and after they have completed the first two cycles of 177Lu-PSMA-I\&T RLT
At least 3 measurable tumours on PSMA PET/CT (>1.5 cm) with sufficiently intense PSMA uptake (SUVmax>20)
ECOG Performance status: 0-1
Blood parameters: a) Leucocytes ≥ 3 G/L; b) Haemoglobin ≥ 100 g/L; c) Thrombocytes ≥ 100 G/L
Estimated glomerular filtration rate (eGFR) > 45 ml/min
Albumin > 25 g/L
ALT, AST, AP: ≤ 5 times upper standard value
Bilirubin ≤ 2 times upper standard value
For male patients who are not surgically sterilized (orchiectomy or vasectomy), appropriate contraceptive measures must be taken during RLT and until 4 months after completion of RLT. As acceptable contraceptive count sexual abstinence or double contraceptive methods: hormonal contraceptive (oral, transdermal, implants or injections) in combination with barrier methods (spiral, condom, diaphragm)

You may not qualify if…

Prior PSMA-targeted RLT (except for the 2 first cycles in Part Ia)
PSMA-negative (or PSMA-negative / FDG-positive) disease
Known intolerance against DOTA, DOTAGA, urea-based analogues or against any of the components/formulation of 177Lu-PSMA-I\&T or 161Tb-SibuDAB solutions.
Ongoing infection at the screening visit or a serious infection in the past 4 weeks
Administration of another investigational product in the last 60 days before Visit 1 Day 1
Prior or planed administration of a therapeutic radiopharmaceutical during 8 half-lives of the used radio-pharmaceutical's radionuclide, also during the ongoing study
Any extensive radiotherapy involving bone marrow over the last 3 months before inclusion to the study
Chemotherapy in the last 4 weeks before inclusion
Any uncontrolled significant medical, psychiatric or surgical condition (active infection, unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension, poorly controlled diabetes mellitus [HbA1c ≥ 9%], uncontrolled congestive heart disease, etc.) or laboratory findings that might jeopardize the patient's safety or that would limit compliance with the objectives and assessments of the study. Any mental conditions which prevent the patient from understanding the type, extent and possible consequences of the study and/or an uncooperative attitude from the patient.
Current history of any malignancy other than prostate cancer within 5 years of enrolment except for fully resected non-melanoma skin cancer

Where it is running

University Hospital Basel — Basel, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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