PRADA-II Trial

• Research type

  Research Study

• Full title

  Pre-operative Radiotherapy And DIEP flAP Reconstruction Trial-II

• IRAS ID

  349225

• Contact name

  Daniel Richard Leff

• Contact email

  d.leff@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Duration of Study in the UK

  6 years, 6 months, 31 days

• Research summary

  Aim: To show that radiotherapy before mastectomy and tissue reconstruction of the breast, leads to improved quality of life compared to radiotherapy after mastectomy.
  Background: Each year in the UK, around 14,850 women with large breast cancers or cancer that has spread to the armpit have a mastectomy (removal of the breast). About 4,600 of these women have breast reconstruction using tissue from their own body. Many also need radiotherapy to reduce the risk of cancer coming back.
  This treatment pathway can be difficult. If reconstruction is done first, it can delay radiotherapy. If radiotherapy is done after, it can damage the reconstructed breast—making it firm, uneven, or smaller. Because of this, some hospitals don’t offer immediate reconstruction if radiotherapy is needed, leaving women without a breast shape for months.
  Research shows that having radiotherapy before surgery is just as safe for cancer treatment and may give better cosmetic results. It could also speed up treatment and recovery, leading to better body image, confidence, and emotional well-being. A large, carefully designed study is needed to prove this and help change NHS guidelines.
  Design: We will invite 450 women from 25 hospitals across the UK to take part. We’ll make sure the group includes women from different backgrounds, including those from lower-income and ethnic minority communities. Women will be randomly split into two groups: one will have radiotherapy before surgery, the other after (standard care). We’ll compare rates of complications, cancer returning, and how women feel about their reconstructed breasts and quality of life. Each woman will fill out questionnaires annually for two years. Photos (kept anonymous) will be reviewed by experts to judge the cosmetic results. We’ll also look at NHS costs to see which approach is more cost-effective.

• REC name

  London - Bromley Research Ethics Committee

• REC reference

  25/LO/0735

• Date of REC Opinion

  4 Dec 2025

• REC opinion

  Further Information Favourable Opinion