Trial Title:
Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer
NCT ID:
NCT06200103
Condition:
Castration-Resistant Prostate Carcinoma
Stage IVB Prostate Cancer AJCC v8
Conditions: Official terms:
Prostatic Neoplasms
Edetic Acid
1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid
Gallium 68 PSMA-11
Pluvicto
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Arm I (177Lu-PSMA-617 standard)
Arm group label:
Arm II (177Lu-PSMA-617 treatment pause)
Arm group label:
Arm III (Treatment pause 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:
Arm I (177Lu-PSMA-617 standard)
Arm group label:
Arm II (177Lu-PSMA-617 treatment pause)
Arm group label:
Arm III (Treatment pause 177Lu-PSMA-617)
Other name:
Bone Scintigraphy
Intervention type:
Other
Intervention name:
Clinical Observation
Description:
Undergo active monitoring
Arm group label:
Arm II (177Lu-PSMA-617 treatment pause)
Arm group label:
Arm III (Treatment pause 177Lu-PSMA-617)
Other name:
observation
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo SPECT/CT or PET/CT
Arm group label:
Arm I (177Lu-PSMA-617 standard)
Arm group label:
Arm II (177Lu-PSMA-617 treatment pause)
Arm group label:
Arm III (Treatment pause 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:
CT
Other name:
CT Scan
Other name:
tomography
Other name:
Computerized Tomography (CT) scan
Intervention type:
Other
Intervention name:
Gallium Ga 68 Gozetotide
Description:
Given IV
Arm group label:
Arm I (177Lu-PSMA-617 standard)
Arm group label:
Arm II (177Lu-PSMA-617 treatment pause)
Arm group label:
Arm III (Treatment pause 177Lu-PSMA-617)
Other name:
(68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
Other name:
(68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC
Other name:
(68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
Other name:
(68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
Other name:
(68Ga)Glu-urea-Lys(Ahx)-HBED-CC
Other name:
68Ga-DKFZ-PSMA-11
Other name:
68Ga-HBED-CC-PSMA
Other name:
68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
Other name:
68Ga-PSMA
Other name:
68Ga-PSMA-11
Other name:
68Ga-PSMA-HBED-CC
Other name:
[68Ga] Prostate-specific Membrane Antigen 11
Other name:
[68Ga]GaPSMA-11
Other name:
AAA 517
Other name:
AAA-517
Other name:
AAA517
Other name:
Ga PSMA
Other name:
Ga-68 labeled DKFZ-PSMA-11
Other name:
Ga-68 labeled PSMA-11
Other name:
GA-68 PSMA-11
Other name:
Gallium Ga 68 PSMA-11
Other name:
Gallium Ga 68-labeled PSMA-11
Other name:
GALLIUM GA-68 GOZETOTIDE
Other name:
Gallium-68 PSMA
Other name:
Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
Other name:
GaPSMA
Other name:
PSMA-HBED-CC GA-68
Intervention type:
Drug
Intervention name:
Lutetium Lu 177 Vipivotide Tetraxetan
Description:
Given IV
Arm group label:
Arm I (177Lu-PSMA-617 standard)
Arm group label:
Arm II (177Lu-PSMA-617 treatment pause)
Arm group label:
Arm III (Treatment pause 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:
Positron Emission Tomography
Description:
Undergo PET/CT
Arm group label:
Arm I (177Lu-PSMA-617 standard)
Arm group label:
Arm II (177Lu-PSMA-617 treatment pause)
Arm group label:
Arm III (Treatment pause 177Lu-PSMA-617)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm I (177Lu-PSMA-617 standard)
Arm group label:
Arm II (177Lu-PSMA-617 treatment pause)
Arm group label:
Arm III (Treatment pause 177Lu-PSMA-617)
Intervention type:
Procedure
Intervention name:
Single Photon Emission Computed Tomography
Description:
Undergo SPECT/CT
Arm group label:
Arm I (177Lu-PSMA-617 standard)
Arm group label:
Arm II (177Lu-PSMA-617 treatment pause)
Arm group label:
Arm III (Treatment pause 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 studies how to improve the usage of Lu 177 vipivotide tetraxetan
(177Lu-prostate-specific membrane antigen [PSMA]-617) for treating patients with
castration-resistant prostate cancer that has spread from where it first started (primary
site), to other places in the body (metastatic) utilizing a treatment pause after 5
cycles of therapy versus standard continuous treatment for 6 cycles. Lutetium is a
radioligand therapy (RLT). RLT uses a small molecule (in this case 177Lu-PSMA-617) that
carries a radioactive component to destroy tumor cells. When lutetium is injected into
the body, it attaches to the PSMA receptor found on tumor cells. After lutetium attaches
to the PSMA receptor, its radiation component destroys the tumor cell. Giving
177Lu-PSMA-617 for 5 cycles versus 6 cycles may better treat patients with metastatic
castrate resistant prostate cancer.
Detailed description:
PRIMARY OBJECTIVES:
I. To determine whether progression-free survival (PFS) per Response Evaluation Criteria
in Solid Tumors (RECIST) 1.1 with Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
criteria is non-inferior among patients randomized to treatment pause versus standard
treatment in patients with metastatic castrate resistant prostate cancer (mCRPC) who have
minimal residual disease on post-therapy single photon emission computed tomography
(SPECT) after 2 to 5 cycles of 177Lu-PSMA-617 treatment.
SECONDARY OBJECTIVES:
I. To compare time to subsequent treatment (TTST) in this patient population between
randomized arms.
II. To assess time to progression (TTP) between randomized arms in this patient
population between randomized arms.
III. To assess overall survival (OS) in this patient population between randomized arms.
IV. To compare toxicities in treatment pause versus standard treatment in this patient
population.
V. To assess changes in patient quality of life (QOL) as measured by the Functional
Assessment of Cancer Therapy - Radionuclide Therapy (FACIT-RNT) for each randomized arm.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive 177Lu-PSMA-617 intravenously (IV) over 10-15 minutes on day 1 of
each cycle. Cycles repeat every 42 days for 5 cycles in the absence of disease
progression or unacceptable toxicity. Patients with a near complete response may receive
1 additional cycle. Patients receive 68Ga-prostate specific membrane antigen-11 (gallium
Ga 68-labeled PSMA-11) IV and undergo positron emission tomography (PET)/computed
tomography (CT) and a bone scan during screening and on the trial. Patients also undergo
SPECT/CT and blood sample collection on the trial.
ARM II: Patients receive 177Lu-PSMA-617 IV over 10-15 minutes on day 1 of each cycle.
Cycles repeat every 42 days for 5 cycles in the absence of disease progression or
unacceptable toxicity. Patients then undergo clinical observation until documented first
progression. After progression, patients resume treatment with 77Lu-PSMA-617 for another
cycle. Patients receive gallium Ga 68-labeled PSMA-11 IV and undergo PET/CT and a bone
scan during screening and on the trial. Patients also undergo SPECT/CT and blood sample
collection on the trial.
ARM III: Patients undergo clinical observation until documented first progression. After
progression, patients receive 177Lu-PSMA-617 IV over 10-15 minutes on day 1 of each
cycle. Cycles repeat every 42 days for 6 cycles in the absence of disease progression or
unacceptable toxicity. Patients receive gallium Ga 68-labeled PSMA-11 IV and undergo
PET/CT and a bone scan during screening and on the trial. Patients also undergo SPECT/CT
and blood sample collection on the trial.
After completion of study treatment, patients are followed up every 12 weeks for up to 2
years or progressive disease.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- REGISTRATION INCLUSION CRITERIA
- Scheduled at Mayo Clinic Rochester for therapy with 177Lu PSMA-617
- PSMA positive metastatic castration resistant prostate cancer (68Ga and 18F PSMA PET
will be considered equivalent for eligibility) , defined by molecular imaging
prostate specific membrane antigen (miPSMA) score >= 2 on Mayo PET report, including
interpretation of outside PET or consensus review of PET by nuclear therapy tumor
board note in the patient chart
- Willingness to provide mandatory blood draws for correlative research. (This
requirement is waived for patients enrolling after receiving cycle 1 of 177Lu
PSMA-617,and achieving a near complete response on post therapy SPECT, as these
patients will not be able to provide a pre-treatment baseline blood sample.)
- Provide written informed consent
- Ability to complete questionnaire(s) by themselves or with assistance
- Willing to return to enrolling institution for follow-up (during the active
monitoring phase of the study)
- RANDOMIZATION INCLUSION CRITERIA
- Lesions with uptake equal to or above liver on cycle 1 post therapy SPECT,
demonstrating that a near complete response on follow up post-therapy scan
represents response, rather than sensitivity differences between SPECT and
pre-treatment PET
- Near-complete response on post-therapy SPECT following any of cycles 2-5 of 177Lu
PSMA-617. Near-complete response will be defined as no lesions with SUV max above
the mean standard uptake value (SUV) of a representative 2cm spherical region of
interest in the central right hepatic lobe, as determined by a nuclear medicine
trained radiologist
- No toxicity that would indicate withholding or reducing dose of the next scheduled
cycle of 177Lu PSMA-617 per prescribing information
- Hemoglobin (Hgb) ≥ 8 g/dL
- Platelets ≥ 75,000/mm^3
- Neutrophils ≥ 100/mm^3
- Estimated glomerular filtration rate (eGFR) < 50 mL/min *body surface area (BSA)
using Cockcroft-Gault formula OR
- Creatinine ≤ 1.5 x upper limit of normal
- Aspartate transferase (AST) or alanine transaminase (ALT) ≤ 3 x upper limit of
normal
- No other unacceptable toxicity in the clinical judgement of the investigators
- RE-REGISTRATION INCLUSION CRITERIA (CROSSOVER TO COMPLETION UPON FIRST PROGRESSION
OF PATIENTS RANDOMIZED TO TREATMENT PAUSE)
- First progression in patients randomized to pause treatment
- PSMA avid lesions on PSMA PET (miPSMA score ≥ 2 following first progression)
Exclusion Criteria:
- REGISTRATION EXCLUSION CRITERIA
- Another active malignancy requiring therapy such as radiation, chemotherapy, or
immunotherapy
- Receiving any other investigational agent which would be considered as a treatment
for the prostate cancer
- Failure to recover from acute, reversible effects of prior therapy regardless of
interval since last treatment
- EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at
least 3 months since completion of prior treatment
- Uncontrolled intercurrent non-cardiac illness including, but not limited to:
- Ongoing or active infection
- Psychiatric illness/social situations
- Dyspnea at rest due to complications of advanced malignancy or other disease
that requires continuous oxygen therapy
- Any other conditions that would limit compliance with study requirements
- Any of the following because this study involves: An investigational agent whose
genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are
unknown
- Persons able to father a child who are unwilling to employ adequate
contraception
- Co-morbid systemic illnesses or other severe concurrent disease which, in the
judgment of the investigator, would make the patient inappropriate for entry into
this study or interfere significantly with the proper assessment of safety and
toxicity of the prescribed regimens
- History of myocardial infarction ≤6 months, or congestive heart failure requiring
use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- RE-REGISTRATION EXCLUSION CRITERIA
- Serious adverse effect
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Matthew P. Thorpe, M.D., Ph.D.
Email:
Principal Investigator
Start date:
May 3, 2024
Completion date:
December 31, 2029
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06200103
https://www.mayo.edu/research/clinical-trials
