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Second chance: focused radiation for recurrent prostate cancer

NCT ID NCT03073278

Disease control Sponsor: Royal North Shore Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial is testing whether a second, highly targeted dose of radiation (SBRT) can safely treat prostate cancer that has returned after initial radiation therapy. The study involves 36 men whose cancer is confined to a small area of the prostate. The main goal is to check for serious side effects and see if higher radiation doses are feasible.

What this could mean

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

Active substance
Stereotactic body radiotherapy (SBRT)
What this could lead to
If successful, this could offer a new treatment option for men whose prostate cancer returns after initial radiation, potentially controlling the disease without more invasive procedures.
What could go wrong
This is a very early, small feasibility trial (36 participants) focused on safety, not effectiveness. The risk of side effects from re-irradiation is unknown, and the approach may not work for all patients.

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 36 people

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

Started

Apr 2017

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

Sex

Male 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: * Men \> 4yrs from external beam radiotherapy (EBRT) meeting the Phoenix definition of biochemical failure or men \> 5yrs from EBRT if neo-adjuvant and/or adjuvant androgen deprivation therapy (ADT) also used * Recurrence localised to less than 1 lobe of prostate on both PMSA and multi-parametric MRI (less than equal to cT2a) * Recurrence must be biopsy proven, with positive biopsies limited to the PET and MRI suspicious region. * Life expectancy at least 10yrs from time of SBRT * PSA \< 10 Exclusion Criteria: * Recurrence in immediate proximity to rectum (unless able to have hydrogel) * Grade 3 or more toxicity from previous EBRT * Contra-indicated for fiducial insertion * GS 8,9 or 10 disease previously (relative - consider if decent disease free interval)

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma

As listed by the trial registrant

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

Locally recurrent prostate cancer

How to take part

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

  1. The places running it

    1 site. 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

  • Royal North Shore Hospital

    RECRUITING

    St Leonards, New South Wales, 2065, Australia

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