Oligometastatic Prostate Cancer (OMPC) by PSMA PET, M1 negative by CI.
Conditions
Interventions
Drug: AAA617 will be administreated once 6 weeks, total 4 times.
Sponsors
Yamauchi Kyosuke
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed prostate cancer prior to randomization 2.Participants must have biochemically recurrent disease after definitive treatment to prostate by Radical Prostatectomy ((RP), (alone or with post-operative radiation to prostate bed/pelvic nodes)) or External beam Radiation Therapy (XRT), (prostate alone or prostate with seminal vesicle and/or pelvic nodes) and/or brachytherapy prior to randomization. 3.Participants must have OMPC with =100 ng/dL at screening.
Exclusion criteria
Exclusion criteria: 1.Participants with de novo OMPC at screening 2.Unmanageable concurrent bladder outflow obstruction or urinary incontinence at screening. 3.Prior therapy with: a.ADT including bilateral orchiectomy b.Other hormonal therapy. c.Radiopharmaceutical agents d.Immunotherapy e.Chemotherapy f.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MFS is defined as the time from randomization to the first evidence of radiographically detectable bone or soft tissue distant metastasis by conventional imaging (i.e., Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) and bone scans) as assessed by BIRC using RECIST 1.1 or death from any cause, whichever occurs first. | — |
Countries
Australia, Austria, Belgium, Canada, Czech Rupublic, France, Germany, Hungary, Italy, Japan, Singapore, Slovakia, Spain, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactKyosuke Yamauchi
Novartis Pharma. K.K.
Outcome results
None listed