Radioligand therapy after radiation for recurrent prostate cancer
Phase 1 Trial to Determine Safety and Feasibility in Treating Biochemical Recurrence Post-Prostatectomy with PSMA PET Guided External Beam Radiotherapy Followed by Consolidative Radioligand Therapy
This study is testing a new treatment using a special radioactive drug after radiation therapy to see if it can help men with recurring prostate cancer while keeping healthy cells safe.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Emory University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT06105918 on ClinicalTrials.gov |
What this trial studies
This phase I trial evaluates the safety and optimal dosage of radioligand therapy using lutetium Lu 177 PSMA-10.1 in patients with biochemically recurrent prostate cancer following external beam radiotherapy guided by PSMA PET imaging. The study aims to determine the feasibility of combining these treatments to enhance tumor cell destruction while minimizing damage to normal cells. Participants will undergo external beam radiation therapy followed by intravenous administration of the radioligand, with assessments of safety, dosimetry, and circulating tumor DNA. Follow-up will occur six weeks after the last treatment to monitor outcomes.
Who should consider this trial
Good fit: Ideal candidates include post-prostatectomy patients with detectable PSA levels and localized pelvic uptake on PSMA PET imaging.
Not a fit: Patients with systemic metastasis or significant contraindications to radiotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective treatment option for patients with recurrent prostate cancer, potentially improving survival rates.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in combining radioligand therapy with other treatments for prostate cancer.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: David M Schuster, MD, FACR — Emory University Hospital/Winship Cancer Institute
- Study coordinator: David M Schuster, MD, FACR
- Email: dschust@emory.edu
- Phone: 404-712-4859
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.