Open-label study comparing 177Lu-PSMA-617 vs. a change of androgen receptor-directed therapy drugs in the treatment of mCRPC.
- Conditions
- Therapeutic area: Diseases [C] - Cancer [C04]PSMA-positive metastatic castration-resistant prostate cancerMedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 100000004864
- Registration Number
- EUCTR2020-003969-19-SE
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 450
1. Signed informed consent must be obtained prior to participation in the
study
2. Participants must be adults = 18 years of age
3. Participants must have an ECOG performance status of 0 to 1
4. Participants must have histological pathological, and/or cytological
confirmation of adenocarcinoma of the prostate
5. Participants must be 68Ga-PSMA-11 PET/CT scan positive, and eligible
as determined by the sponsor's central reader
6. Participants must have a castrate level of serum/plasma testosterone
(< 50 ng/dL or < 1.7 nmol/L)
7a. Participants must have progressed only once on prior second
generation ARDT (abiraterone, enzalutamide, darolutamide, or
apalutamide).
• first generation androgen receptor inhibitor therapy (e.g.
bicalutamide) is allowed but not considered as prior ARDT therapy
• second generation ARDT must be themost recent therapy received
8. Participants must have progressive mCRPC. Documented progressive
mCRPC will be based on at least 1 of the following criteria:
• Serum/plasma PSA progression defined as 2 increases in PSA
measured at least 1 week apart. The minimal start value is 2.0 ng/mL;
1.0 ng.mL is the minimal starting value if confirmed rise in PSA is the
only indication of progression
• Soft-tissue progression defined [PCWG3-modified RECIST v1.1
(Eisenhauer et al 2009, Scher et al 2016)]
• Progression of bone disease: two new lesions; only positivity on the
bone scan defines metastatic disease to bone (PCWG3 criteria (Scher et
al 2016))
9a. Participants must have = 1 metastatic lesion that is present on
screening/baseline CT, MRI, or bone scan imaging obtained = 28 days
prior to randomization
10. Participants must have recovered to = Grade 2 from all clinically
significant toxicities related to prior therapies (i.e. prior chemotherapy,
radiation, etc.) except alopecia
Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 315
1. Previous treatment with any of the following within 6 months of
randomization: Strontium 89, Samarium-153, Rhenium-186, Rhenium-
188, Radium-223, hemi-body irradiation
2. Previous PSMA-targeted radioligand therapy
3a. Prior treatment with cytotoxic chemotherapy for
castration resistant or castrate sensitive prostate cancer (e.g., taxanes,
platinum, estramustine, vincristine, methotrexate, etc.), immunotherapy
or biological therapy [including monoclonal antibodies]. [Note: Taxane
exposure (maximum 6 cycles) in the adjuvant or neoadjuvant setting is
allowed if 12 months have elapsed since completion of this adjuvant or
neoadjuvant therapy. Prior treatment with sipuleucel-T is allowed.]
4. Any investigational agents within 28 days prior to day of
randomization
5. Known hypersensitivity to any of the study treatments or its
excipients or to drugs of similar classes
6a. Concurrent cytotoxic chemotherapy, immunotherapy, radioligand
therapy, PARP inhibitor, biological, or investigational therapy
7. Transfusion or use of bone marrow stimulating agents for the sole
purpose of making a participant eligible for study inclusion
8a. Participants with a history of CNS metastases who are neurologically
unstable, symptomatic, or receiving corticosteroids for the purpose of
maintaining neurologic integrity. Participants with CNS metastases are
eligible if received therapy (surgery, radiotherapy, gamma knife),
asymptomatic and neurologically stable without corticosteroids.
Participants with epidural disease, canal disease and prior cord
involvement are eligible if those areas have been treated, are stable, and
not neurologically impaired.
9. Symptomatic cord compression, or clinical or radiologic findings
indicative of impending cord compression
10. History or current diagnosis of the following ECG abnormalities
indicating significant risk of safety for study participants:
• Concomitant clinically significant cardiac arrhythmias, e.g. sustained
ventricular tachycardia, complete left bundle branch block, high-grade
AV block (e.g., bifascicular block, Mobitz type II and third degree AV
block)
• History of familial long QT syndrome or known family history of
Torsades de Pointe
• Cardiac or cardiac repolarization abnormality, including any of the
following: History of myocardial infarction (MI), angina pectoris, or
CABG within 6 months prior to starting study treatment
other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method