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The mechanism is scientifically sound and consistently supported by animal data, but human efficacy and safety have not been established through clinical trials

Paradoxically, while normal prostate physiology prioritizes polyamine synthesis (e.g., spermine), regulated by androgen-dependent enzymes like ODC to support secretory functions, PCa progression exhibits a contradictory polyamine landscape: spermine levels decline sharply despite ODC overexpression, a phenomenon contrasting with polyamine accumulation patterns in other cancers

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