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Can treating less breast tissue mean fewer radiation side effects?

NCT ID NCT07811635

Symptom relief Sponsor: Jinnah Postgraduate Medical Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

The PRISM trial compares two radiation approaches after breast-conserving surgery for early-stage breast cancer. One approach treats only the area around the original tumor, while the other treats the whole breast. Both use the same short schedule of five radiation treatments. Researchers will track skin side effects reported by doctors and patients over 12 months to see if partial breast radiation causes fewer problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ultra-hypofractionated radiation therapy, given either to part of the breast or the whole breast
What this could lead to
If partial breast radiation causes fewer skin side effects while controlling cancer as well as whole breast radiation, it could become a preferred option for some women with early-stage breast cancer.
What could go wrong
This is a phase II trial with 100 women, so it may not detect small differences in side effects or long-term cancer control. Partial breast radiation could miss cancer cells outside the treated area, and longer follow-up is needed to confirm it works as well as whole breast radiation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women aged ≥45 years. * Newly diagnosed, histologically confirmed breast carcinoma, including Invasive Ductal Carcinoma (IDC), Invasive Lobular Carcinoma (ILC), or Ductal Carcinoma in Situ (DCIS). * Early-stage disease (T1-T2, node-negative \[N0\]), with no evidence of distant metastasis. * Hormone receptor-positive disease (ER and/or PR positive). * HER2-positive disease, provided patients have received or are receiving appropriate HER2-targeted therapy, as per institutional practice. * Patients who have undergone breast-conserving surgery with no tumor on inked margins or no residual disease following re-excision. Exclusion Criteria: * Age \<45 years. * Multicentric disease. * Locally advanced or node-positive disease (T3-T4 and/or N+) or evidence of distant metastasis. * Lobular Carcinoma In Situ (LCIS). * Triple-negative breast cancer. * Positive surgical margins or incomplete breast-conserving surgery not suitable for re-excision. * Prior ipsilateral breast irradiation. * Non-breast malignancy within the past 5 years, except treated non-melanoma skin cancer or in-situ carcinoma. * Pregnancy or lactation at enrollment. * Inability to identify the tumor bed on planning Computed Tomography (CT), such as absence of surgical clips or seroma. * Unacceptable radiotherapy planning feasibility for the experimental technique according to protocol constraints.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm radiation injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer early stage breast cancer (stage 1-3)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Radiation Oncology, Cyberknife and Tomotherapy Center, Jinnah Postgraduate Medical Centre (JPMC), Karachi, Pakistan

    Karachi, Pakistan

  • Department of Radiation Oncology, King Abdulaziz University, Jeddah, Saudi Arabia

    Jeddah, Saudi Arabia

  • Gulf International Cancer Centre City, Country: Abu Dhabi; UAE

    Abu Dhabi, United Arab Emirates

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