Information for participants

Overview 

PROTECTOR is a research study for women (people assigned female at birth) who are at an increased risk of developing ovarian cancer. Individuals may have an increased risk of developing ovarian cancer for several reasons, for example:  

• They carry an alteration in certain genes such as: BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, or PALB2. 
• They have a strong family history of ovarian cancer. 

We currently have 39 hospitals across England, Wales, Scotland and Northern Ireland which are recruiting participants to PROTECTOR. We aim to recruit 2500 participants in total. Participants can choose to be in one of three study arms: 

1. Risk-Reducing Salpingo-Oophorectomy (RRSO)

The most effective method to prevent ovarian cancer is surgery to remove both the fallopian tubes (‘tubes’) and ovaries. This procedure is called ‘risk reducing salpingo-oophorectomy’ (RRSO). This significantly reduces the risk of ovarian cancer by up to 96%. However, in premenopausal women, removing the ovaries causes early menopause, which causes symptoms and may have long-term consequences for general health.

2. An Alternative “Two-Step” Procedure  
PROTECTOR offers women a new alternative two-step surgery to prevent ovarian cancer. This procedure is called ‘risk reducing early 
salpingectomy with delayed oophorectomy’ (RRESDO). The ‘first’ step involves an operation to remove the  fallopian tubes only. This may somewhat reduce ovarian cancer risk without causing early menopause. The ‘second’ step involves removing the ovaries in a second operation. This can take place at any time after the first operation, at a time up to the individual’s choosing. Alternatively, individuals can have the second operation once they have reached menopause naturally (which on average is 51 years in the UK).  

3. Control (No surgery) 
Some people may not yet feel ready, or may not wish, to have surgery to remove their tubes and ovaries- either in one step (RRSO) or in two steps (RRESDO). However, they can still take part in the study as a control participant. A control participant is someone who helps researchers by providing a comparison. By following their health over time, researchers can better understand what would happen without the surgery and compare this to those who do have it. 

Aims and Objectives 
The study assesses how much removing the fallopian tubes early, and the ovaries at a later date lowers the risk of ovarian cancer in women who are at high risk. It also assesses women’s views and the impact of this two-step surgery to prevent ovarian cancer on sexual function, hormone levels, quality of life and overall satisfaction.  
Outcomes from this new approach are compared to the traditional approach of removal of both tubes and ovaries in the same operation (RRSO). We will also compare this to the well-being of women who choose not to have surgery. Women will be able to choose which arm of the study they wish to take part in.