The PROTECTOR Study

03 March 2020

What does PROTECTOR stand for?

Preventing Ovarian cancer through early Excision of Tubes and late Ovarian Removal 

What is this study about?

Current guidelines for women carrying a faulty gene that puts them at greater risk of ovarian cancer (e.g. BRCA1, BRCA2, RAD51C, RAD51D or BRIP1) are to undertake risk-reducing surgery after they’ve completed their families (from mid-30s onwards). This involves removing both fallopian tubes and ovaries (bilateral salpingo-oophorectomy), and this puts a woman into immediate early menopause which has risks for the woman’s long term health. Early menopause is associated with side effects like hot flushes, sweats, mood changes, thinning of the bones, memory problems and a higher risk of heart disease. It may also reduce libido and impair sexual function. Many women take hormone replacement therapy to minimise these side effects. Some number of women choose to decline or delay this operation to avoid the potential symptoms or problems of early menopause. 

Scientists believe that most ovarian cancers begin in the fallopian tube not the ovary, and so removing the tubes will prevent a number of cancers while avoiding problems of early menopause. 

What we don’t know is, for high risk women, what is the risk reduction of removing only their fallopian tubes to start with, and then waiting until closer to natural menopause to remove their ovaries? Would women be happy with this process? Would this option impact their wellbeing in a good way?

The PROTECTOR study aims to look at this two-step option, and compare it to both the traditional surgery (removing tubes and ovaries at the same time) and to women who don’t have surgery. The study is aiming to recruit 1,000 participants in total (333 in each of these groups). 

The researchers will look at women’s own views of their experiences, the impact on sexual function, hormone levels, quality of life and overall satisfaction. 

Women will be able to choose which route they decide to go down (so you can get involved even if you’re not planning on having surgery soon.) 

How do I know if I’m eligible to take part?

You can take part if you meet all of the following criteria:

  • You are at increased risk of ovarian cancer either because you carry a mutation in your BRCA1, BRCA2, RAD51C, RAD51D or BPRIP1 gene, or you have a strong family history of ovarian cancer.
  • You are aged over 30 years and have not gone through the menopause
  • You have not had ovarian/tubal/primary peritoneal cancer yourself
  • You are not pregnant
  • You have completed your family (this applies if you are choosing to have an operation to reduce your ovarian cancer risk. You can also take part in the study if you’re not planning to have an operation soon)

What will happen if I decide to take part?

You will be given the choice of which arm of the study you wish to be part of:

  • RRESDO

    RRESDO

    The new, two staged operation to prevent ovarian cancer (initial removal of tubes followed by later removal of ovaries at a second operation).

  • RRSO

    RRSO

    The current operation which is standard of care on the NHS (removal of both tubes and ovaries at the same time).

  • Control group

    Controls

    No operation involved.

Crucially, women who have chosen to delay removing their ovaries, or to not have any surgery can switch to having surgery of their choice whenever they want to. 

You will be followed up for three years, asked to complete questionnaires and will have follow-up blood tests to monitor hormone levels. 

You may also be invited to take part in interviews with a researcher. Interviews will explore your views on surgery for preventing ovarian cancer as well as health and wellbeing after surgery.

Who is running the study?

The study team is led by Prof Ranjit Manchanda, Wolfson Institute of Preventive Medicine, Barts CRUK centre, London. There are 29 centres across England, Wales, Scotland and Northern Ireland which are recruiting participants to PROTECTOR. 

The study has been reviewed by the London - Bloomsbury Research Ethics Committee (18/LO/0555). It has also been reviewed by a large team of doctors and researchers who are experts in the field of cancer prevention.

How can I find out more?

You can find out more about the study here

If you would like to take part, please ask your GP to refer you to your nearest recruitment centre which can be found using the interactive map found on the website (http://protector.org.uk/). 

Alternatively, you may contact a member of the PROTECTOR team (bci-protector@qmul.ac.uk) for further details on how to take part.