PSMAfore: A phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of androgen receptor-directed therapy in the Treatment of Taxane Naïve Men with Progressive Metastatic Castrate Resistant Prostate Cancer
- Conditions
- prostaat kankeruitgezaaide prostaatkanker
- Registration Number
- NL-OMON52179
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
• Participants must have an ECOG performance status of 0 to 1
• Participants must have histological pathological, and/or cytological
confirmation of adenocarcinoma of the prostate
• Participants must be 68Ga-PSMA-11 PET/CT scan positive, and eligible as
determined by the sponsor*s central reader
• Participants must have a castrate level of serum/plasma testosterone (< 50
ng/dL or < 1.7 nmol/L)
• 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
• 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 thebone scan
defines
metastatic disease to bone (PCWG3 criteria (Scher et al 2016))
• Participants must have >= 1 metastatic lesion that is present on
screening/baseline CT, MRI, or bone scan imaging obtained <= 28 days prior to
beginning study therapy
• Participants must have recovered to <= Grade 2 from all clinically significant
toxicities related to prior therapies (i.e. prior chemotherapy, radiation,
etc.) except alopecia
• Participants must have adequate organ function
- 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
- Previous PSMA-targeted radioligand therapy
- 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
- Any investigational agents within 28 days prior to day of
randomization
- Known hypersensitivity to any of the study treatments or its
excipients or to drugs of similar classes
- Other concurrent cytotoxic chemotherapy, immunotherapy,
radioligand therapy, PARP inhibitor, biologicals or investigational therapy
- Transfusion or use of bone marrow stimulating agents for the sole
purpose of making a participant eligible for study inclusion
- Patients with a history of CNS metastases that 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),
XML File Identifier: TAvYk8QpGNNGCZNzW8LbncoFA8o=
Page 23/37
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.
- Symptomatic cord compression, or clinical or radiologic findings
indicative of impending cord compression
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate whether treatment with 177Lu-PSMA-617 improves the time to<br /><br>radiographic progression by BICR according PCWG3-modified RECIST v1.1 or death<br /><br>in participants with progressive PSMA-positive mCRPC compared to participants<br /><br>treated with ARDT</p><br>
- Secondary Outcome Measures
Name Time Method <p>key secondary:<br /><br>To evaluate whether treatment with 177Lu-PSMA-617 improves the overall survival<br /><br>(OS) in participants with progressive PSMA-positive mCRPC compared to<br /><br>participants treated with ARDT treatment<br /><br><br /><br>other:<br /><br>To estimate the time to radiographic progression by BICR or death in<br /><br>participants treated with ARDT who subsequently crossover to 177Lu-PSMA-617<br /><br>after radiographic progression (rPFS2)<br /><br><br /><br>for more see page 14 in the protocol</p><br>