Intended for healthcare professionals


Patients’ roles and rights in research

BMJ 2018; 362 doi: (Published 25 July 2018) Cite this as: BMJ 2018;362:k3193

Re: Patients’ roles and rights in research

Men should be warned about uncertain safety of multi-needle prostate biopsy.

Godlee et al. stress that researchers must accept patients as full partners included in design, conduct and reporting of clinical research, along with presenting and disseminating results to participants and relevant communities (1). However, patient/research subjects must also take centre stage regarding safety.

Population screening for prostate cancer with PSA has failed to improve men’s survival. Treatment outcomes remain disappointing, especially following radical surgery for ‘early intra-capsular disease’. Five recent studies report underestimation of tumour extent on histology of excised prostate glands: in a third of men malignant tissue was outside the capsule; in a quarter tumour tissue was incompletely removed in the unsuccessful operation (2-6).

Nevertheless, urologists press on, using ever-increasing numbers of biopsy cores in men with only slight elevation of PSA, seemingly indifferent to the possibility of local extension and needle track spread. Thus, this potential adverse event has not been routinely sought. Suggestions that MRI scan post-positive biopsy might accurately assess the extent of malignant tissue before treatment decision-making have been disregarded (7). Men managed by 'watchful waiting or ‘active surveillance’ may receive repeat interval biopsies with additional risks of local tumour extension each time.

Without adequate investigation of potential local effects of multi-needle prostate biopsy, there is uncertainty about harm. Not looking leads to ‘lack of evidence' which should not be accepted as ‘evidence of no harm’.

Men should be warned that multi-needle prostate biopsy has the potential to cause extra-capsular tumour spread.

G. David Stainsby, FRCS, Retired Consultant Orthopaedic Surgeon
Susan Bewley, MD FRCOG c/o Department of Women’s and Children’s Health, Kings College London

Declaration of interest: GDS participated in the ProTecT trial (2). Unusually, post positive biopsy, he underwent ultrasound examination which showed unexpected extra-capsular tumour spread, confirmed and demonstrated in greater detail by MRI scan.


1. Wicks P, Richards T, Denegri S, Godlee F. Patients’ roles and rights in research. BMJ 2018;362:k3193.
2. ProtecT study. Prostate testing for cancer and Treatment. HTA No 96/20/99. Principal investigators: FC Hamdy, JL Donovan, DE Neal. Coordinator: JA Lane.
3. Gardiner RA, Yaxley I, Coughlin G, et al. A randomised trial of robotic and open prostatectomy in men with localised prostate cancer. BMC Cancer 2012;12:189. [PMID: 22632109].
4. Yaxley JW, Coughlin GD, Chambers SK, et al. Robot-assisted laparoscopic prostatectomy versus open radical retro-pubic prostatectomy: early outcomes from a randomised controlled phase 3 study. The Lancet; 2016;388:1057-66. [PMID:27474375].
5. Pearce SM, Pariser JJ, Karrison T, Pate SG, Eggener SE. Comparison of perioperative and early oncological outcomes between open and robotic assisted laparoscopic prostatectomy in a contemporary population based cohort. J Urol 2016;196:76-81. [PMID: 26860793].
6. National Prostate Cancer Audit 2016 Annual Report
7. Stainsby GD. 10-Year Outcomes in Localised Prostate Cancer. Letter to Editor. N Engl J Med 2017; 376: 178-181. January 12: 2017.

Competing interests: No competing interests

17 September 2018
G. David Stainsby
Retired Consultant Orthopaedic Surgeon (Newcastle upon Tyne)
Susan Bewley (c/o Department of Women’s and Children’s Health, Kings College London)