Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT05496959
Eligibility Criteria:
Inclusion Criteria:
* Oligorecurrent prostate cancer as determined by the presence of 1-5 asymptomatic lesions outside the prostate or prostate bed identified on PSMA PET/CT by local readers
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* No indication for urgent or emergent radiation
* Histologic confirmation of prostate adenocarcinoma (histology from original treatment acceptable)
* White blood cell count \>= 2.5 × 10\^9/L
* Platelets \>= 100 × 10\^9/L
* Hemoglobin \>= 9 g/dL
* Total bilirubin =\< 1.5 × institutional upper limit of normal (ULN); or up to 3 × ULN if known history of Gilbert's syndrome
* Alanine aminotransferase or aspartate aminotransferase =\< 3.0 × ULN or =\< 5.0 × ULN for patients with liver metastases
* Serum creatinine =\< 1.5 × ULN or creatinine clearance \>= 50 mL/min
* Serum albumin \> 3.0 g/dL
* Partner and patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principal investigator during the study and for 3 months after last study drug administration
* Ability to understand, and willingness to sign, the written informed consent
Exclusion Criteria:
* Patients with neuroendocrine or small cell carcinoma of the prostate
* Patients with castrate-resistant disease (i.e., PSA \> 0.5 ng/mL with serum testosterone \< 150 ng/dL)
* Patients who received androgen deprivation therapy within 6 months of trial enrollment
* Concurrent systemic therapy for a solid organ malignancy
* Spinal cord compression
* Inability to lie flat
* Known hypersensitivity to components of 177Lu-PNT2002
* Serum creatinine \> 1.5 × ULN or creatinine clearance \< 50 mL/min
* Total bilirubin \> 1.5 × ULN or \> 3.0 × ULN if known history of Gilbert's syndrome
* Alanine aminotransferase or aspartate aminotransferase \> 3 × ULN (or 5 × ULN for patients with known liver metastases)
* De novo oligometastatic disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05496959
Study Brief:
Protocol Section:
NCT05496959