Occasional Contributor


Today was day 7 of my 28 days of radiation treatment on the return of PCa 8 years after my radical prostatectomy (RP). My journey began in May 1990 when a 17mm hypo echoic area showed up on a U/S scan. Two months later a further scan reported a focal lucency. A scheduled biopsy was cancelled due to emerging doubts over U/S capacity to recognise cancer. Through to July 2015 my BPH was medically treated with Prazosin with 12 months of Duodart added. A rise in PSA from Duodart's 1.15 March 2014 to 2.62 in June 2015 led to MRI and RP that November.

My Urologist had always told me that something other than PCa would kill me and that has kept me secure during all this time. Awaiting today's treatment I struck up a conversation with another patient. He was 80 with 7 more treatments to go on his prostate. He said his aggression grade was the worst form of PCa and he had already been told his current treatment would be unsuccessful and the next round of some other action would also fail. I did not know how this could be possible and tried to improve his outlook with my 8 years post RP and another at least 5 years to any expected doom.

The entire staff at our hospital are brilliant as have most of my medical people been along the way. My radiation choice has been hampered by the limited amount of information available due to a shortfall in data collection. Two Urologists came up with “ take no action till PSA went from 0.80 to 10.00” and “radiate the 1 detected spot". Oncology from “radiate the whole field" to “only radiate the pelvic area excluding the bowel, bladder and old prostate areas”. I went for the 4th option hoping PCa doesn't return to the excluded areas.

I am convinced much more post-approval data on medicines and procedures, especially Duodart and biopsies, is required. Hopefully the Health Department's Therapeutical Goods Administration (TGA) generally ensures new medicines and treatments are extensively trialed and supervised ahead of release. It then does practically nothing to monitor subsequent outcomes and results. Their Database of Adverse Events Notifications (DAEN) has a lot of data about things like headaches but is scant on some much more serious complaints and outcomes. This leaves the industry with a shortfall of information necessary for proper choice. BPH options range from medical to surgery and cost is a likely reason for the lack of TGA interest on outcomes for these choices. Proper data on MRIs and PSMA Scans performance could see risky biopsies removed from the required procedures list.

5-alpha-reductase inhibitors finasteride and dutasteride are widely prescribed for treatment of BPH. Prostate issues have a high rate of progression to PCa. PBH is frequent in a high percentage of men as they age yet TGA has only 8 cases of PCa on Duodart's (dutasteride) DAEN even though the database is only including cases where the disease just simply follows the use. It does not indicate cause. This scenario is evidence of how little data is collected in just that one case. If that is how the TGA operates it is certain other adverse effects are never discovered.

Almost every male my age I converse with tells me they are on Duodart. I would expect from this that at least 100,000 Australian men would be on Duodart. I could not learn the exact number but this must be known at the Department of Health through their PBS records but cannot be obtained. As a high proportion of BPH sufferers progress to PCa the number that were prescribed Duodart must be in the tens of thousands. Somehow the TGA's data of men that progressed after taking Duodart is only 8 and only one since September 2017. Even if you accept the drug does not or rarely causes Cancer this data should be more correct.

It beggars belief that statistics to be used in important medical decisions are collected in such a perfunctory manner. When Covid pre release investigation was so scantily performed it is appalling that post-release information is collected in such a way. With the vast improvement of PCa detection procedures the risk of spreading the cancer through biopsies must also be questioned.



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