PSMA-DC: An Open-label study comparing lutetium (177Lu) vipivotide tetraxetan (also known as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereinafter referred to as AAA617) versus observation in PSMA positive OMPC (CAAA617D12302).

JRCT ID: jRCT2031230608

Registered date:31/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Oligometastatic Prostate Cancer (OMPC) by PSMA PET, M1 negative by CI.
• Date of first enrollment: 01/04/2024
• Target sample size: 20
• Countries of recruitment: Australia,Japan,Austria,Japan,Belgium,Japan,Canada,Japan,Czech Rupublic,Japan,France,Japan,Germany,Japan,Hungary,Japan,Italy,Japan,Singapore,Japan,Slovakia,Japan,Spain,Japan,Switzerland,Japan,Taiwan,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): Drug: AAA617 will be administreated once 6 weeks, total 4 times.

Outcome(s)

• Primary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Male

Include 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 =<5 PSMA-positive metastatic lesions on screening PSMA PET/CT scan (with either gallium (68Ga) gozetotide or piflufolastat (18F)) as visually assessed by BIRC based on the methodology proposed in the Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE v2).
4.At least 1 PSMA-positive lesion should be a distant metastasis (M1) per AJCC8 classification at screening. For AJCC M staging, PSMA PET information should be used
5.Participants must have a negative conventional imaging for M1 disease at screening
6.All metastatic lesions detected at screening should be amenable to SBRT.
7.Non-castration testosterone level >100 ng/dL at screening.

Exclude 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.

Related Information

• Primary Sponsor: Yamauchi Kyosuke
• Secondary ID(s): NCT05939414