Vorinostat and 177Lu-PSMA-617 for the Treatment of PSMA-Low Metastatic Castration-Resistant Prostate Cancer
NCT ID: NCT06145633
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
15 participants
INTERVENTIONAL
2024-09-18
2027-12-30
Brief Summary
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Detailed Description
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Patients receive vorinostat orally (PO) once a day (QD) for 28 days and then receive gallium Ga 68 gozetotide intravenously (IV) and undergo a positron emission tomography (PET) scan on trial. Patients may go on to receive 177Lu-PSMA-617 IV per standard of care (SOC) on day 1 of each cycle. Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) and bone scan on trial and during follow-up, as well as a fludeoxyglucose F-18 (FDG) PET/CT during screening and on trial and single photon emission computed tomography (SPECT)/CT on trial. Patients undergo blood sample collection on trial and may also optionally undergo biopsy during screening and on trial.
After completion of study treatment, patients are followed up every 8 weeks for 6 months and then every 12 weeks for up to 2 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (vorinostat, 177Lu-PSMA-617)
Patients receive vorinostat PO QD for 28 days and then receive gallium Ga 68 gozetotide IV and undergo a PET scan on trial. Patients may go on to receive 177Lu-PSMA-617 IV per SOC on day 1 of each cycle. Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT and bone scan on trial and during follow-up, as well as a FDG PET/CT during screening and on trial and SPECT/CT on trial. Patients undergo blood sample collection on trial and may also optionally undergo biopsy during screening and on trial.
Biopsy Procedure
Undergo biopsy
Biospecimen Collection
Undergo blood sample collection
Bone Scan
Undergo bone scan
Computed Tomography
Undergo CT, PET/CT, SPECT/CT
Fludeoxyglucose F-18
Undergo FDG PET/CT
Gallium Ga 68 Gozetotide
Given IV
Lutetium Lu 177 Vipivotide Tetraxetan
Given 177Lu-PSMA-617
Positron Emission Tomography
Undergo 68Ga-PSMA-11 PET
Single Photon Emission Computed Tomography
Undergo SPECT/CT
Vorinostat
Given IV
Interventions
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Biopsy Procedure
Undergo biopsy
Biospecimen Collection
Undergo blood sample collection
Bone Scan
Undergo bone scan
Computed Tomography
Undergo CT, PET/CT, SPECT/CT
Fludeoxyglucose F-18
Undergo FDG PET/CT
Gallium Ga 68 Gozetotide
Given IV
Lutetium Lu 177 Vipivotide Tetraxetan
Given 177Lu-PSMA-617
Positron Emission Tomography
Undergo 68Ga-PSMA-11 PET
Single Photon Emission Computed Tomography
Undergo SPECT/CT
Vorinostat
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient must have evidence of castration resistant prostate cancer as evidenced by PSA progression (per Prostate Cancer Working Group 3 \[PCWG3\] criteria) and a castrate serum testosterone level (i.e., ≤ 50 mg/dL).
* PSMA SUVmean \< 10 as determined by 68Ga-PSMA-11 PET.
* Patients must have received a next-generation androgen receptor-signaling inhibitor (e.g. abiraterone, enzalutamide, apalutamide, darolutamide). There must be at least a 2-week washout period after stopping these agents. Patients should be weaned off steroids at least 1 week prior to starting treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by CT and/or bone scan and is suitable for repeated assessment.
* Hemoglobin ≥ 10 g/dL (measured within 28 days prior to administration of study treatment)
* Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (measured within 28 days prior to administration of study treatment)
* Platelet count ≥ 100 x 10\^9/L (measured within 28 days prior to administration of study treatment)
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (measured within 28 days prior to administration of study treatment)
* Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN (measured within 28 days prior to administration of study treatment) . For patients with known Gilbert's Syndrome they must be ≤ 3 x ULN (measured within 28 days prior to administration of study treatment)
* Calculated creatinine clearance ≥ 50 mL/min (using Cockcroft-Gault formula) (measured within 28 days prior to administration of study treatment)
* Patients and their partners, who are sexually active and of childbearing potential must agree to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for 3 months after last dose of study drug to prevent pregnancy in a partner.
* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
Exclusion Criteria
* Evidence of metastatic neuroendocrine/small cell prostate cancer (NEPC). Note: baseline biopsy is not required but is strongly encouraged if a patient is found to have an FDG-positive/PSMA-negative lesion on baseline imaging.
* Patients receiving any systemic therapy (aside from an luteinizing hormone-releasing hormone \[LHRH\] analogue) or radiotherapy within 2 weeks prior to study treatment.
* Any previous treatment with an HDAC inhibitor (including valproic acid) or 177Lu-PSMA-617.
* Persistent toxicities (CTCAE grade \>2) from prior cancer therapy, excluding alopecia and stable neuropathy.
* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder or active, uncontrolled infection. Examples include, but are not limited to uncontrolled seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
* Patients who are known to be serologically positive for human immunodeficiency virus (HIV) and a CD4 count \< 200.
* Patients with known active hepatitis (i.e. Hepatitis B or C). Prior Hep C infection is allowed as long as polymerase chain reaction (PCR) is negative.
* Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
* Deep vein thrombosis or pulmonary embolism diagnosed within the past six months.
* Active use of coumarin-derived anticoagulant medication (i.e. warfarin).
* Serious cardiac disorder, including but not limited to uncontrolled ventricular arrhythmia, recent (within 12 months) myocardial infarction, resting electrocardiogram (ECG) indicating Fridericia's corrected QT interval prolongation \> 500ms, or congenital long QT syndrome.
MALE
No
Sponsors
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Novartis
INDUSTRY
Institute for Prostate Cancer Research (IPCR)
UNKNOWN
National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Michael Schweizer
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2023-08921
Identifier Type: REGISTRY
Identifier Source: secondary_id
FHIRB0020244
Identifier Type: OTHER
Identifier Source: secondary_id
RG1123920
Identifier Type: -
Identifier Source: org_study_id
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