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

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.

Start Date20 Feb 2024

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100 Clinical Results associated with [161Tb]Tb-SibuDAB

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100 Patents (Medical) associated with [161Tb]Tb-SibuDAB

Literatures (Medical) associated with [161Tb]Tb-SibuDAB

01 Apr 2025·European Journal of Nuclear Medicine and Molecular Imaging

First-in-human administration of [161Tb]Tb-SibuDAB and comparative dosimetry with standard [177Lu]Lu-PSMA-I&T as part of the PROGNOSTICS phase Ia study

Article

Author: McDougall, Lisa ; Müller, Cristina ; Tschan, Viviane J ; Westerbergh, Frida ; Schmid, David E ; Aceto, Nicola ; Geistlich, Susanne ; van der Meulen, Nicholas P ; Chirindel, Alin ; Busslinger, Sarah D ; Bernhardt, Peter ; Wild, Damian ; Fokkema, Angelique ; Schibli, Roger ; Nicolas, Guillaume P

We present results from the first patient in the PROGNOSTICS (NCT06343038) Phase Ia study, a prospective, single-center, single-blind trial aiming to translate [161Tb] Tb-SibuDAB to clin. radioligand therapy (RLT).In Phase Ia of the PROGNOSTICS study, mCRPC patients with stable disease on [177Lu]Lu-PSMA-I&T RLT receive two test injections: 1 GBq [177Lu]Lu-PSMA-I&T and 1 GBq [161Tb]Tb-SibuDAB, administered 3 wk apart in random order.Quant. SPECT/CT imaging was performed at 3, 24, 48, and 168 h post-injection.Tumor and organ absorbed doses were computed using a 75 keV±10% window for 161Tb (low-energy high-resolution collimator) and a 208 keV±10% window for 177Lu (mediumenergy low-penetration collimator), using a Monte Carlo OSEM reconstruction algorithm.Safety and acute toxicity (CTCAE 5.0) along with transcriptional "omics" and circulating tumor cells were evaluated after each test injection.First-in-human data suggest [161Tb]Tb-SibuDAB is a promising radiopharmaceutical for the current indication of RLT in mCRPC.The potential to enhance treatment durability against micrometastases could be further explored in a neo/adjuvant setting.The planned dose escalation study (Phase Ib of PROGNOSTICS) will assess the efficacy, toxicity, and therapeutic index of [161Tb]Tb-SibuDAB.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic castration-resistant prostate cancer	Phase 1	Switzerland	-	20 Feb 2024
Metastatic Prostate Carcinoma	Phase 1	Switzerland	-	20 Feb 2024
PSMA-Positive Castration-Resistant Prostatic Cancer	Phase 1	Switzerland	-	20 Feb 2024

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


PROGNOSTICS (SNMMI2026)	Phase 1	Metastatic castration-resistant prostate cancer	6	[161Tb]Tb-SibuDAB (3.0 GBq)	jjmygjycbl(uupoilzxeq) = entry dose (3.0 GBq): anemia (n=1), thrombocytopenia (n=1), leukopenia (n=1) and lymphopenia (n=1). 4.5 GBq dose level: anemia (n=1), thrombocytopenia (n=2), leukopenia (n=1), neutropenia (n=1) and lymphopenia (n=1). In both cohorts, there were grade 3 leukopenia (n=2, one each cohort) and no grade 4/5 hematologic toxicity. ftgnaxoumz (jfrddwtfjy ) View more	Positive	27 May 2026
				[161Tb]Tb-SibuDAB (4.5 GBq)

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