An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.

Exclusion Criteria

• •6. All metastatic lesions detected at screening must be amenable to SBRT
• •7. Non-castration testosterone level \>100 ng/dL at screening
• •1. Participants with de novo OMPC at screening
• •2. Unmanageable concurrent bladder outflow obstruction or urinary incontinence at screening. Note: participants with bladder outflow obstruction or urinary incontinence, which is manageable and controlled with best available standard of care (incl. pads, drainage) are allowed
• •3. Prior therapy with:
• •1. ADT (including bilateral orchiectomy) and ARPIs used for metastatic prostate cancer treatment
• •* Participants who received AR-directed therapy, whether ADT or an ARPI or both, as neoadjuvant or adjuvant therapy as a component of their primary therapy, are eligible provided that they discontinued therapy ≥12 months prior to randomization for ADT (i.e., 12 months after the last day of the last injection) or ≥3 months if ARPI was given as monotherapy. ARPI's as a term includes both contemporary androgen synthesis inhibitors (e.g., abiraterone, galeterone, and orteneronel), and receptor inhibitors (enzalutamide, apalutamide and darolutamide).
• •* Patients who biochemically relapsed after primary therapy may also have had treatment with AR directed therapy and participants who had SBRT with ADT are also eligible provided that the ARPI +/- ADT or ADT alone was terminated
• •≥12 months prior to randomization for ADT (i.e., 12 months after the last day of the last injection) or ≥3 months if ARPI was given as monotherapy.
• •* Participants who received first generation anti-androgens (bicalutamide, flutamide, nilutamide, cyproterone) for biochemical recurrence or adjuvant/neoadjuvant therapy are eligible provided that they discontinued therapy ≥3 months prior to randomization.
• •2. Other hormonal therapy. e.g.,
• ••Use of estrogens, 5-α reductase inhibitors (finasteride, dutasteride), other steroidogenesis inhibitors (aminoglutethimide) if used in the context of prostate cancer treatment. Same medications are allowed if used for other indications: e.g., Benign Prostatic Hyperplasia (BPH), if stopped ≥3 months before randomization.
• •3. Radiopharmaceutical agents (e.g., Strontium-89, PSMA-targeted radioligand therapy)
• •4. Immunotherapy (e.g., sipuleucel-T)
• •5. Chemotherapy, except if administered in the adjuvant/neoadjuvant setting completed \> 12 months before randomization
• •6. Any other investigational or systemic agents for metastatic disease
• •4. Radiation therapy external beam radiation therapy (EBRT) and brachytherapy within 28 days before randomization
• •5. Concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, hormonal therapy (see ADT initiation guidance in Section 6.8.2), Poly Adenosine Diphosphate-Ribose Polymerase (PARP) inhibitor, biological therapy or investigational therapy
• •6. Diagnosed at screening with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease/treatment free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer and superficial bladder cancer.
• •7. History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants participating in the study such as:
• •* Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, and clinically significant second or third degree Atrioventricular (AV) block without a pacemaker
• •* History of familial long QT syndrome or known family history of Torsades de Pointe
• •8. Participants in immediate need of ADT as assessed by the investigator.
• •Other protocol defined Inclusion/Exclusion may apply.