Trial Title:
Radioligand Therapy After PSMA PET Guided External Beam Radiotherapy for Treating Post-Prostatectomy Patients With Biochemically Recurrent Prostate Cancer
NCT ID:
NCT06105918
Condition:
Biochemically Recurrent Prostate Carcinoma
Prostate Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Prostatic Neoplasms
Fluorides
Study type:
Interventional
Study phase:
Phase 1
Overall status:
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 (EBRT, 177Lu-rhPSMA-10.1)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo rhPSMA-7.3 PET/CT and SPECT-CT
Arm group label:
Treatment (EBRT, 177Lu-rhPSMA-10.1)
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
Intervention type:
Radiation
Intervention name:
External Beam Radiation Therapy
Description:
Undergo EBRT
Arm group label:
Treatment (EBRT, 177Lu-rhPSMA-10.1)
Other name:
Definitive Radiation Therapy
Other name:
EBRT
Other name:
External Beam Radiation
Other name:
External Beam Radiotherapy
Other name:
External Beam Radiotherapy (conventional)
Other name:
External Beam RT
Other name:
external radiation
Other name:
External Radiation Therapy
Other name:
external-beam radiation
Other name:
Radiation, External Beam
Other name:
Teleradiotherapy
Other name:
Teletherapy
Other name:
Teletherapy Radiation
Intervention type:
Other
Intervention name:
Flotufolastat F-18
Description:
Given IV
Arm group label:
Treatment (EBRT, 177Lu-rhPSMA-10.1)
Other name:
(18F)-rhPSMA-7.3
Other name:
18F-rhPSMA-7.3
Other name:
18FrhPSMA-7.3
Other name:
F-18-rhPSMA-7.3
Other name:
Fluorine F 18 radiohybrid PSMA-7.3
Other name:
Fluorine F 18 rhPSMA-7.3
Other name:
Fluorine-18 rhPSMA-7.3
Other name:
rhPSMA-7.3 (18F)
Intervention type:
Drug
Intervention name:
Lutetium Lu 177 PSMA-10.1
Description:
Given IV
Arm group label:
Treatment (EBRT, 177Lu-rhPSMA-10.1)
Other name:
(177Lu) rhPSMA-10.1
Other name:
177Lu Radiohybrid PSMA-10.1
Other name:
177Lu rhPSMA-10.1
Other name:
177Lu-rhPSMA-10.1
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo rhPSMA-7.3 PET/CT
Arm group label:
Treatment (EBRT, 177Lu-rhPSMA-10.1)
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:
Procedure
Intervention name:
Single Photon Emission Computed Tomography
Description:
Undergo SPECT-CT scan
Arm group label:
Treatment (EBRT, 177Lu-rhPSMA-10.1)
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 I trial tests the safety, side effects and best dose of radioligand therapy
(lutetium Lu 177 PSMA-10.1 [177Lu-rhPSMA-10.1]) after prostate specific membrane antigen
(PSMA) positron emission tomography (PET)-guided external beam radiotherapy in treating
post-prostatectomy patients with prostate cancer that has come back after a period of
improvement (recurrent). In this study, radioligand therapy is a radioactive drug called
177Lu-rhPSMA-10.1. It works by binding to PSMA-expressing prostate tumor cells and
delivering the radioactive portion of the drug directly to the tumor cells while not
harming normal cells. Radiation therapy such as external beam radiotherapy uses high
energy x-rays to kill tumor cells and shrink tumors. Giving radioligand therapy with PSMA
PET-guided external beam radiotherapy may kill more tumor cells in post-prostatectomy
patients with biochemically recurrent prostate cancer.
Detailed description:
PRIMARY OBJECTIVES:
I. Demonstrate the safety and feasibility of treating radiotherapy (RT) prostate cancer
patients via addition of lutetium Lu 177 PSMA-10.1 (177Lu-rhPSMA-10.1) in a selected
post-prostatectomy population.
II. Analyze dosimetry of radioligand therapy (RLT) after each cycle of 177Lu-rhPSMA-10.1.
EXPLORATORY OBJECTIVE:
I. Determine the feasibility of and develop preliminary data in the correlation of
circulating tumor circulating tumor deoxyribonucleic acid (ctDNA) at baseline, after RT,
and RLT.
OUTLINE: This is a dose-escalation study of 177Lu-rhPSMA-10.1.
Patients undergo external beam radiation therapy (EBRT) followed by 177Lu-rhPSMA-10.1
intravenously (IV) on study. Patients also receive flotufolastat F-18 (rhPSMA-7.3) IV
with positron emission tomography (PET)/computed tomography (CT) at screening and undergo
single-photon emission computed tomography (SPECT)-CT and collection of blood samples on
study.
Patients follow up 6 weeks after the last 177Lu-rhPSMA-10.1 administration.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Adenocarcinoma of the prostate, post radical prostatectomy with detectable prostate
specific antigen (PSA)
- Clinical PSMA PET/CT obtained, with findings of pelvic uptake only (prostate bed,
pelvic lymph node uptake, or both)
- Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2
- Age over 18
Exclusion Criteria:
- Contraindications to radiotherapy (including active inflammatory bowel disease or
prior pelvic radiotherapy or prior RLT)
- Risk factors for Lu-rhPSMA radioligand therapy (Baseline >= grade 2
myelosuppression, renal insufficiency [glomerular filtration rate (GFR) < 60
mL/min], or xerostomia)
- Definitive findings of systemic metastasis prior imaging (if obtained) or biopsy (if
obtained)
- Unacceptable medical or radiation safety risk
- Unmanageable urinary tract obstruction or hydronephrosis; patients with diagnosed or
who are at high risk of urinary retention
- GFR < 60 mL/min or creatinine > 1.5-fold upper limit of normal (ULN)
- Liver enzymes > 5-fold ULN
- Total white cell count less than 2.5 x 10^9 /L
- Platelet count less than 75 x 10^9 /L
- Any baseline grade 2 or above myelosuppression, nephrotoxicity, hepatotoxicity,
xerostomia, or gastrointestinal (GI) toxicity
- Severe acute co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization in
the last 3 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the
time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of
registration
- Acquired immune deficiency syndrome (AIDS) based upon current Centers for
Disease Control and Prevention (CDC) definition; note, however, that human
immunodeficiency virus (HIV) testing is not required for entry into this
protocol. The need to exclude patients with AIDS from this protocol is
necessary because the treatments involved in this protocol may be significantly
immunosuppressive. Protocol-specific requirements may also exclude
immunocompromised patients
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Emory University Hospital/Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Recruiting
Contact:
Last name:
David M. Schuster, MD, FACR
Phone:
404-712-4859
Email:
dschust@emory.edu
Contact backup:
Last name:
Bridget Fielder, RN
Email:
bfielde@emory.edu
Investigator:
Last name:
David M. Schuster, MD, FACR
Email:
Principal Investigator
Start date:
November 29, 2023
Completion date:
April 1, 2029
Lead sponsor:
Agency:
Emory University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Emory University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06105918
