Testing AAA617 with piflufolastat for oligometastatic prostate cancer (OMPC)

Exclusion

• −Participants with de novo OMPC at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
• −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 careStandard of careThe treatment normally given for a condition outside a study.Read more → (incl. pads, drainage) are allowed
• −Prior therapy with:
• −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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → 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.
• −Participants who have discontinued ADT due to disease progression are not eligible (i.e., Castration-Resistant Prostate Cancer (CRPC) participants)
• −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.
• −Radiopharmaceutical agents (e.g., Strontium-89, PSMA-targeted radioligand therapy)
• −Any other investigational or systemic agents for metastatic disease
• −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.
• −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
• −Participants in immediate need of ADT or other systemic therapy as assessed by the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →. In addition, investigators should only enroll participants who are committed to delay castration in accordance with the scope of the study and are willing to wait to start systemic therapy until distant progression (MFS event) as assessed by CIConfidence intervalA range showing how precisely a result has been pinned down.Read more → (consisting with existing treatment guidelines) and confirmed by BIRC is reached. This must be discussed with the participants before ICFInformed consentThe process of being told what taking part involves, then choosing freely.Read more → is signed.
• −Other protocolProtocolThe detailed plan a study must follow.Read more → defined InclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/ExclusionExclusion criteriaThe things that would prevent someone from taking part.Read more → may apply.
• −Immunotherapy (e.g., sipuleucel-T)
• −Chemotherapy, except if administered in the adjuvant/neoadjuvant setting completed \> 12 months before randomization
• −Radiation therapy external beam radiation therapy (EBRT) and brachytherapy within 28 days before randomization
• −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