Status:
ACTIVE_NOT_RECRUITING
Radioligand Therapy After PSMA PET Guided External Beam Radiotherapy for Treating Post-Prostatectomy Patients With Biochemically Recurrent Prostate Cancer
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Biochemically Recurrent Prostate Carcinoma
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief 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 emissi...
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-p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2029
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06105918
Start Date
November 29 2023
End Date
April 1 2029
Last Update
December 9 2025
Active Locations (1)
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1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322