Trial Title:
Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing Disease
NCT ID:
NCT06526299
Condition:
Castration-Resistant Prostate Carcinoma
Metastatic Prostate Carcinoma
Stage IVB Prostate Cancer AJCC v8
Conditions: Official terms:
Carcinoma
Prostatic Neoplasms
1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid
Pluvicto
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Treatment (177Lu-PSMA-617)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Bone Scan
Description:
Undergo bone scan
Arm group label:
Treatment (177Lu-PSMA-617)
Other name:
Bone Scintigraphy
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo SPECT/CT and CT
Arm group label:
Treatment (177Lu-PSMA-617)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Drug
Intervention name:
Lutetium Lu 177 Vipivotide Tetraxetan
Description:
Given IV
Arm group label:
Treatment (177Lu-PSMA-617)
Other name:
177Lu-labeled PSMA-617
Other name:
177Lu-PSMA-617
Other name:
AAA 617
Other name:
AAA-617
Other name:
AAA617
Other name:
Lu177-PSMA-617
Other name:
Lutetium Lu 177-PSMA-617
Other name:
LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
Other name:
Lutetium-177-PSMA-617
Other name:
Pluvicto
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (177Lu-PSMA-617)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Procedure
Intervention name:
PSMA PET-CT Scan
Description:
Undergo PSMA PET/CT
Arm group label:
Treatment (177Lu-PSMA-617)
Other name:
PET-CT (PSMA)
Other name:
Prostate-specific Membrane Antigen PET-CT
Other name:
PSMA PET-CT
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Treatment (177Lu-PSMA-617)
Intervention type:
Procedure
Intervention name:
Single Photon Emission Computed Tomography
Description:
Undergo SPECT/CT
Arm group label:
Treatment (177Lu-PSMA-617)
Other name:
Medical Imaging, Single Photon Emission Computed Tomography
Other name:
Single Photon Emission Tomography
Other name:
Single-Photon Emission Computed
Other name:
single-photon emission computed tomography
Other name:
SPECT
Other name:
SPECT imaging
Other name:
SPECT SCAN
Other name:
SPET
Other name:
ST
Other name:
tomography, emission computed, single photon
Other name:
Tomography, Emission-Computed, Single-Photon
Summary:
This phase II trial tests how well 177Lu-PSMA-617 works in treating patients with
prostate cancer that has spread from where it first started (primary site) to other
places in the body (metastatic) and that remains despite treatment (resistant). Lutetium
Lu 177 (177Lu), the radioactive (tracer) component being delivered by prostate-specific
membrane antigen (PSMA)-617, has physical properties that make it ideal radionuclide
(imaging tests that uses a small dose tracer) for treatment of metastatic
castrate-resistant prostate cancer (mCRPC). 177Lu-PSMA-617 works by binding to prostate
cancer cells and inducing damage to deoxyribonucleic acid (DNA) inside prostate cancer
cells. Giving 177Lu-PSMA-617 may improve treatment outcomes for patients with mCRPC.
Detailed description:
OUTLINE:
Patients receive 177Lu-PSMA-617 intravenously (IV) over 30 minutes on days 1, 8, 50, 57,
99 and 141. Treatment repeats every 7 days for cycles 1 and 3 and every 6 weeks for cycle
2 and subsequent cycles for up to 6 cycles in the absence of disease progression or
unacceptable toxicity. Patients undergo PSMA positron emission tomography/computed
tomography (PET/CT) during screening and single photon emission computed tomography
(SPECT)/CT on study. Patients also undergo CT or magnetic resonance imaging (MRI), bone
scan, as well as blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 30 days and then every
12 weeks for up to 2 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients must have the ability to understand and sign an approved informed consent.
- Patients must have the ability to understand and comply with all protocol
requirements.
- Patients must be ≥ 18 years of age.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status
of 0 to 2.
- Patients must have a life expectancy > 6 months.
- Patients must have histological, pathological, and/or cytological confirmation of
prostate cancer.
- Patients must have a positive 68Ga-PSMA PET/CT scan with no PSMA negative lesion, as
determined by the Nuclear Medicine site investigator. The presence of PSMA-positive
lesions was defined as 68Ga-PSMA-11 uptake greater than that of liver parenchyma in
one or more metastatic lesions of any size in any organ system. PSMA negative
disease defined as lymph nodes of 2.5 cm or visceral lesions or soft tissue
component of a lytic bone lesion of 1.0 cm or larger with uptake less than that of
liver parenchyma.
- Patients must have whole body tumor SUVmean of < 10 on 68Ga-PSMA PET/CT scan, as
determined by the Nuclear Medicine site investigator. 68GaPSMA PET/CT will be
analyzed using a semi-quantitative approach with MIM software (MIM Software Inc.).
The workflow identified whole-body regions of interest (ROIs) with an maximum
standardized uptake value (SUVmax) greater than 3 and a lesion size of at least 0.5
mm. The reviewer then manually removes any instances of physiological activity or
uptake that are not related to the disease. The method of whole-body quantification
will automatically calculate the whole body SUVmean.
- Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy and
a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L).
- Patients must have received at least one androgen receptor pathway inhibitor (ARPI)
(such as enzalutamide and/or abiraterone).
- Patients must have been previously treated with at least 1, but no more than 2
previous taxane regimens.
- Patients must have progressive mCRPC. Documented progressive mCRPC will be based on
at least 1 of the following criteria:
- Serum PSA progression defined as 2 consecutive increases in PSA over a previous
reference value measured at least 1 week prior. The minimal start value is 2.0
ng/mL.
- Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter
(SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all
target lesions based on the smallest SOD since treatment started or the
appearance of one or more new lesions.
- Progression of bone disease: evaluable disease or new bone lesions(s) by bone
scan (2+2 Prostate Cancer Working Group 3 (PCWG3) criteria, Scher et al 2016).
- Patients must have ≥ 1 metastatic lesion that is present on baseline CT, MRI, or
bone scan imaging obtained ≤ 30 days prior to beginning study therapy. Measurable
disease by per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
is not required, as prostate cancer patients may not have RECIST-measurable disease
but have detectable disease on bone scan.
- Patients must have recovered to ≤ grade 2 from all clinically significant toxicities
related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy,
etc.).
- White blood cell (WBC) count ≥ 2.5 x 10^9/L (2.5 x 10^9/L is equivalent to 2.5 x
10^3/uL and 2.5 x K/uL and 2.5 x 10^3/cumm and 2500/uL) OR absolute neutrophil count
(ANC) ≥ 1.5 x 10^9/L (1.5 x 10^9/L is equivalent to 1.5 x 10^3/uL and 1.5 x K/uL and
1.5 x 10^3/cumm and 1500/uL).
- Platelets ≥ 100 x 10^9/L (100 x 10^9/L is equivalent to 100 x 10^3/uL and 100 x K/uL
and 100 x 10^3/cumm and 100,000/uL).
- Hemoglobin ≥ 9 g/dL (9 g/dL is equivalent to 90 g/L and 5.59 mmol/L).
- Total bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN). For patients
with known Gilbert's syndrome ≤ 3 x ULN is permitted.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 x ULN OR ≤
5.0 x ULN for patients with liver metastases.
- Albumin > 3.0 g/dL (3.0 g/dL is equivalent to 30 g/L).
- Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min.
- Patients on a stable bisphosphonate or denosumab regimen for ≥ 30 days prior to
enrollment are eligible.
- HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes
are included in this trial. HIV-infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months are eligible for this trial.
- For patients who have partners of childbearing potential: Partner and/or patient
must use a method of birth control with adequate barrier protection, deemed
acceptable by the principal investigator during the study and for 14 weeks after
last study drug administration. The patients should not donate sperm throughout the
treatment period and for 14 weeks following the last treatment.
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV
viral load must be undetectable on suppressive therapy, if indicated. Patients with
a history of hepatitis C virus (HCV) infection must have been treated and cured. For
patients with HCV infection who are currently on treatment, they are eligible if
they have an undetectable HCV viral load.
Exclusion Criteria:
- Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188,
Radium-223 or hemi-body irradiation within 6 months prior to treatment day 1.
Previous PSMA-targeted radioligand therapy is not allowed.
- Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological
therapy [including monoclonal antibodies]) within 30 days prior to treatment day 1.
- Any investigational agents within 30 days prior to treatment day 1.
- Known hypersensitivity to the components of the study therapy or its analogs.
- Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or
investigational therapy.
- Transfusion within 30 days of treatment day 1.
- Patients with a history of central nervous system (CNS) metastases must have
received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable,
asymptomatic, and not receiving corticosteroids for the purposes of maintaining
neurologic integrity. Patients 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.
- Concurrent serious (as determined by the Principal Investigator) medical conditions,
including, but not limited to, New York Heart Association class III or IV congestive
heart failure, history of congenital prolonged QT syndrome, uncontrolled infection,
active hepatitis B or C, or other significant co-morbid conditions that in the
opinion of the investigator would impair study participation or cooperation.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Investigator:
Last name:
Thomas Hope
Email:
Principal Investigator
Facility:
Name:
Olive View-University of California Los Angeles Medical Center
Address:
City:
Sylmar
Zip:
91342
Country:
United States
Investigator:
Last name:
Jeremie Calais
Email:
Principal Investigator
Facility:
Name:
Fred Hutch/University of Washington Cancer Consortium
Address:
City:
Seattle
Zip:
98109
Country:
United States
Contact:
Last name:
Akshata Mathur
Phone:
206-667-5801
Email:
nucmedresearch@fredhutch.org
Investigator:
Last name:
Amir Iravani, MD FRACP
Email:
Principal Investigator
Start date:
December 1, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
University of Washington
Agency class:
Other
Collaborator:
Agency:
Novartis
Agency class:
Industry
Collaborator:
Agency:
Society of Nuclear Medicine and Molecular Imaging (SNMMI) Mars Shot Research Fund
Agency class:
Other
Source:
University of Washington
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06526299
