NCT06343038 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
| NCT ID | NCT06343038 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Castration-resistant Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-02-20 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 25 participants in total. It began in 2024-02-20 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Contact & Investigator
Alin Chirindel, MD
PRINCIPAL INVESTIGATOR
University Hospital, Basel, Switzerland
Frequently Asked Questions
Who can join the NCT06343038 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Castration-resistant Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06343038 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06343038 currently recruiting?
Yes, NCT06343038 is actively recruiting participants. Contact the research team at damian.wild@usb.ch for enrollment information.
Where is the NCT06343038 trial being conducted?
This trial is being conducted at Basel, Switzerland.
Who is sponsoring the NCT06343038 clinical trial?
NCT06343038 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Alin Chirindel, MD at University Hospital, Basel, Switzerland. The trial plans to enroll 25 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.