2 Research recommendations

The Guideline Development Group has made the following recommendations for research, based on its review of evidence, to improve NICE guidance and patient care in the future. The Guideline Development Group's full set of research recommendations is detailed in the full guideline.

2.1 Prognostic indicators

Further research is required into the identification of prognostic indicators in order to differentiate effectively between men who may die with prostate cancer and those who might die from prostate cancer. [2008]

Why this is important

The greatest uncertainties in managing prostate cancer are around the identification of which cancers are of clinical significance and over the choice of radical treatment, and in which settings they are appropriate. With the diagnosis of prostate cancer being made more frequently in asymptomatic men, it is of growing importance to know which of these men are likely to benefit from aggressive treatment.

2.2 Androgen deprivation therapy and/or brachytherapy added to radiotherapy for men with intermediate- and high-risk localised non-metastatic prostate cancer

Does the addition of androgen deprivation therapy and/or brachytherapy to high-dose external beam radiotherapy improve outcomes for men with intermediate- and high-risk localised non-metastatic prostate cancer? Outcomes of interest are biochemical disease-free survival, metastasis-free survival, overall survival, side effects and quality of life. [new 2014]

Why this is important

There is insufficient evidence on the effectiveness of adding androgen deprivation therapy or brachytherapy, or both, to external beam radiotherapy (using current optimal techniques) in men with intermediate- and high-risk localised non-metastatic prostate cancer.

Randomised controlled trials should compare the effectiveness of the following:

  • external beam radiotherapy combined with androgen deprivation therapy

  • external beam radiotherapy combined with brachytherapy

  • external beam radiotherapy combined with androgen deprivation therapy and brachytherapy

  • external beam radiotherapy alone.

2.3 Local salvage therapies in men with biochemical relapse after radiotherapy

Clinical trials should be set up to examine the effect of local salvage therapies on survival and quality of life in men with biochemical relapse after radiotherapy. [2008]

Why this is important

Salvage local therapies after radiotherapy include radical prostatectomy, cryotherapy and high-intensity focused ultrasound, but little evidence exists to support their use, and there may be a higher risk of incontinence, impotence and rectal damage than when used as primary treatment.

2.4 Bisphosphonates and denosumab to treat osteoporosis

What is the clinical and cost effectiveness of standard care with bisphosphonates compared with denosumab to treat osteoporosis caused by long-term androgen deprivation therapy? Outcomes of interest are bone mineral density, fracture risk, tolerability and skeletal-related events. [new 2014]

Why this is important

Men having long-term androgen deprivation therapy for prostate cancer have an increased fracture risk. Osteoporosis (NICE clinical guideline 146) recommends that fracture risk be assessed when starting long-term androgen deprivation therapy but the effectiveness of interventions such as bisphosphonates and denosumab in men with an increased fracture risk is not known.

2.5 Duration of exercise to combat fatigue in men having androgen deprivation therapy

Does a longer (more than 12 weeks) programme of supervised aerobic resistance exercise reduce fatigue more effectively than a 12-week programme in men having androgen deprivation therapy? Outcomes of interest are measures of fatigue, aerobic capacity, cardiovascular function and quality of life. [new 2014]

Why this is important

A 12-week programme of supervised aerobic resistance exercise given for 12 weeks has been shown to improve quality of life and reduce side effects for men having androgen deprivation therapy for prostate cancer. It is not clear whether continuing the exercise programme beyond 12 weeks will result in further improvements.

  • National Institute for Health and Care Excellence (NICE)