Key information

Recruitment dates:

14 November, 2018 to 31 July, 2025
(Trial recruitment open)

Treatment stage:

prevention/diagnosis

Trial investigator:

Dr Ranjit Manchanda

Barts Cancer Institute, QMUL, and Consultant Gynaecological Oncologist at Barts and the Royal London Hospital.

Email: bci-protector@qmul.ac.uk

Trial website:

Tags:

BRCA
prevention

Acronym:

PROTECTOR

Clinical trial locations

Location list

Address:
The Royal London Hospital
Whitechapel Road
London
London
E1 1BB

Introduction

PROTECTOR is a research study for women who are at an increased risk of developing ovarian cancer. Some women may carry a fault/alteration in their BRCA1 or BRCA2 gene making them high risk. Whilst others may be at an increased risk due to a strong family history of cancer or a fault in another ovarian cancer causing gene like RAD51C, RAD51D or BRIP1.

The currently advised practice is to offer an operation to remove both tubes and ovaries to prevent ovarian cancer in women at increased risk. This is undertaken after a woman has completed her family. It is called risk reducing salpingo oophorectomy or RRSO. (Salpingo-oophorectomy = removal of tubes and ovaries). Removing both tubes and ovaries (RRSO) at present is the most effective or best way we have to prevent ovarian cancer in women who are at increased risk.

About the trial

It is now well established that a large proportion of ovarian cancers start in the tube. A number of experts believe that removing the tubes alone would provide some protection from getting ovarian cancer  This ‘first stage’ is called risk reducing early salpingectomy (RRES). (Salpingectomy = removal of tubes). This may be particularly helpful for those women who wish to avoid or delay menopause. Women who just have their fallopian tubes removed will need to have a second operation at a later date to remove their ovaries. This ‘second stage’ can be undertaken once they reach the menopause or at a date closer to menopause whenever the woman wishes. This is called Delayed Oophorectomy (DO). (Oophorectomy = removal of ovaries). This is essential to provide optimal protection against ovarian cancer. Both operations are usually carried out by keyhole surgery (laparoscopy) under general anaesthesia.

This study aims to assess the impact on women of the new two-step option to prevent ovarian cancer. The study assesses women’s views and the impact of this approach to prevent ovarian cancer on sexual function, hormone levels, quality of life and overall satisfaction.


In this study the outcomes of women undergoing this new two stage operation (RRES + DO) are compared with the outcomes from women undergoing standard operation of removing both tubes and ovaries at the same time (RRSO). There will also be a comparison with the outcomes of women who have no operation (controls). Women are free to choose whichever of the three options they prefer.

 

There will be 27 recruitment sites in the UK. Please go to the study website protector.org.uk to find an interactive map of the recruitment sites/hospitals running the study. There is also detailed information for participants on the PROTECTOR website. Women will need to ask their GP to refer them to the most appropriate recruitment hospital. 

 Alternatively, please contact the PROTECTOR team via the website for further details on how to take part.

Who can take part?

This trial is for women who are at an increased risk of developing ovarian cancer. This is either because they carry an alteration/fault in one of the ovarian cancer genes like BRCA1, BRCA2, RAD51C, RAD51D, or BRIP1 or because they have a strong family history that puts you at higher risk of developing ovarian cancer.

To take part in the trial participants must be:

  • Aged 30 years and over and have not gone through the menopause.
  • Have completed their family and if they are choosing to undergo an operation to prevent ovarian cancer.  
  • Women may also take part if they are not currently planning to have an operation to reduce their risk (control arm).

 

Locations for the trial can be found here: http://protector.org.uk/map-of-recruitment-centres/#d.en.591341

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.