Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc

Exclusion Criteria

• •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
• •* Herbal and non-herbal products that may decrease PSA levels other than medical castration and megestrol (up to 40 mg/day is allowed) for hot flashes
• •* Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
• •Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
• •If a subject has undergone major surgery, they must have recovered adequately from the toxicities or complications from the intervention within 4 weeks prior to starting therapy
• •History of non-prostate active malignancy requiring treatment in the 24 months prior to Day 1 except for non-muscle invasive urothelial cancer, non-melanoma skin cancer, or any cancer that in the opinion of the investigator has been adequately treated and will not interfere with study procedures or interpretation of results
• •Active infection or conditions requiring treatment with antibiotics
• •Symptomatic local recurrence in the setting of prior curative intent therapy (surgery and/or radiation to the prostate)
• •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
• •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
• •Subject is planning to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment
• •Current or impending cord compression or another indication for urgent palliative radiation therapy