TrialBridgeNCT06084338
Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc
Recruiting · Phase 2 · VA Office of Research and Development · registry updated 2025-12-31
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This trial tests if the combination of comprehensive metastasis directed therapy delivered by a precision form of external beam radiotherapy (stereotactic ablative radiotherapy), combined with PSMA targeted radiopharmaceutical therapy and cessation of castration, and then followed by testosterone replacement, is an effective treatment for metastatic castration resistant prostate cancer. All patients will be treated with stereotactic ablative radiotherapy and PSMA targeted radiopharmaceutical therapy with cessation of castration. Half of patients are randomized to either receive, or not receive, subsequent testosterone replacement.
Inclusion
- Subject must be 18 years of age or older at the time the Informed Consent is signed
- The subject (or legally acceptable representative if applicable) must provide written informed consent for the trial
- Pathologic diagnosis of prostate cancer of adenocarcinoma histology; presence small cell/neuroendocrine carcinoma is exclusionary
- Metastatic disease as documented by:
- Osseous metastases detected by technetium-99m (99mTc) planar bone scan or NaF PET scan, or CT scan at some point in patient's history
- Soft tissue metastases documented on CT or MRI
Exclusion
- Visceral metastases including liver and brain (lung metastases are allowed)
- Small cell/neuroendocrine carcinoma by hematoxylin and eosin light histology (immunohistochemical detection of rare/occasional cells that stain for neuroendocrine markers such as synaptophysin, neuron specific enolase, or chromogranin A is not sufficient to make a diagnosis of small cell/neuroendocrine carcinoma)
- Anti-neoplastic therapies for prostate cancer must be completed \> 2 weeks prior to Day 1 (initiation of first dose of PSMA RLT)
- Investigational agents must have been completed \> 4 weeks of Day 1
- Note: Participants must have recovered from all AEs due to previous therapies to Grade 1 or baseline
- Participants with Grade 2 neuropathy may be eligible