TOAD - Timing of androgen deprivation intervention in prostate cancer patients with a rising PSA

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This is a clinical trial for patients with prostate cancer. The aim of the project is to provide information about the best timing to start treatment in men who have a rising PSA (prostate specific antigen) blood test, after having had treatment with the aim of curing their prostate cancer. In some men, the surgery or radiotherapy given initially in the attempt to cure the cancer is not successful. One of the earliest ways of detecting recurrence of the cancer in these men is with the PSA blood test, which can detect activity of the cancer months or years before other tests, and usually long before any symptoms appear. We know that treatment with hormone therapy – removing the male hormone testosterone – is helpful in controlling advanced disease causing symptoms, although it is not a cure. This is called ‘androgen deprivation’, testosterone being an androgen hormone. The cancer cells are deprived of a source of energy, keeping them under control for a while, but eventually they tend to start growing again in spite of the treatment. We know that using androgen deprivation usually causes the PSA level in men to fall, including men in your situation who have no other signs of active cancer. What we do not know is whether using androgen deprivation immediately the PSA starts to rise will prolong life more than waiting to start treatment until there are other signs that the disease is progressing. It would be simple to start everyone on treatment with androgen deprivation if there were no side effects with the treatment. However, there are a number of side effects that may interfere with day-to-day living. These include (but are not limited to): hot flushes, tiredness, anaemia, and loss of muscle mass and bone density. There may be weight gain, and nipple tenderness or swelling. Some men notice changes in mental function, or shortness of breath. Most also find that sex drive and erectile function, if normal before starting treatment, cease. Quality of life may be affected. If androgen deprivation therapy is ceased, some of the side effects (such as loss of sex drive, loss of muscle bulk or bone mineral density) may be halted or reversed. Generally the standard approach would be to delay introducing treatment until the disease progresses. So the purpose of the study is to see whether immediate treatment is better or worse than delayed treatment in terms of prolonging lifespan, balanced against the effects on the quality of life.

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