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tonymax posted a topic in New agentsPLATO is a 2 stage Clinical Trial with 500 patients (80% in Australia, rest in Finland, UK and USA). On Stage1 everyone gets Enzalutamide (no placebo). [Xtandi is the brand name for Enzalutamide] Those continuing in Stage 2 are randomised: 50% of patients to Abiraterone plus placebo and 50% of patients to Abiraterone plus Enzalutamide. Both arms in Stage 2 also get Prednisone to go with the Abiraterone. Stage 2 is double blind so neither doctor or patient know which arm you are in. Also in Stage 2 they do not do PSA tests but track the tumour with scans. That sounds a little scary! If I get twitchy, I may have to cheat – or just turn off the brain, lie back and think of England. To qualify for Stage 2 you need to continue to meet the original general requirements for the trial. The original changeover point from Stage 1 to Stage 2 was defined as a 25% increase in PSA over a 1 or 2 month period following the nadir (lowest point). This has now been relaxed by adding a second additional requirement – growth in tumours or metastases as shown by CT or bone scan. All men on the trial had to have CT or bone scan visible tumours or metastases at the start of Stage 1. My tumour was only discovered at PSA 70 just before start of Stage 1. Given they now know where it is, they may be able to track its growth at lower PSA’s but the effect of adding this second requirement would likely give me more time on Stage 1 than originally which should be a positive – my tumour is probably currently invisible at PSA 13. I have a Clinical Trial consultation every 4 weeks and, of course, I chat with the other guys in the waiting room – and they with me. I started the trial in June 2014 – most guys started between Jan 2014 and June 2014. Their PSA’s at start of the trial vary a lot – 30 to 500 on the guys I have talked to. All seem to be getting a reasonable response but the details vary a lot – how fast it drops, how low it goes, how long it stays there etc etc. I have not spoken to anyone yet who is on stage 2. With the trial we are doing two sequences of PSA tests to monitor results: 1.Local pathology lab (Douglass) Results 65 (June 14), 38, 25, 15, 20 (end Nov) and 13 (23 Dec) 2.Official trial pathology lab in Singapore Singapore result end Nov was 14. It looks like my PSA results are bottoming out in the 10-15 range and the local end Nov result is incorrect. What side effects have I had from my treatment so far on the trial? My main side effect from Lucrin over the last 11-12 years has been fatigue – in my case always there but manageable. The only side effect I get from Enzalutamide is substantially increased fatigue – to the point of needing a doze most afternoons. Talking to doctors and patients, substantially increased fatigue is the main Enzalutamide side effect for most men.