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Precision radiation aims to stall prostate cancer spread

NCT ID NCT04983095

Disease control Sponsor: Karin Soderkvist 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether adding precise, high-dose radiation (SBRT) to standard hormone therapy can delay cancer progression in men with prostate cancer that has spread to 1-3 spots. About 118 participants will be randomly assigned to get SBRT plus standard care or standard care alone. The goal is to see if the radiation helps keep the cancer from growing longer.

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) plus standard hormone therapy
What this could lead to
If it works, this could improve control of prostate cancer that has spread to a few spots, delaying the need for stronger treatments.
What could go wrong
This is a phase III trial but still early in recruitment. The benefit may be small, and radiation can cause side effects like fatigue or local irritation.

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 118 people

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

Started

Oct 2021

Expected to finish

Dec 2033

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: 1. Histologically confirmed prostate cancer (ICD-O-3 C61) 2. WHO/ECOG performance status 0-1 3. 1-3 skeletal or extra pelvic lymph node metastases detected by PSMA-PET/CT in de novo prostate cancer or PSA-relapse after definitive RT or prostatectomy 4. Willing and able to provide informed consent- Exclusion Criteria: 1. Castration resistant prostate cancer (progression with castrate levels of testosterone) 2. Any treatment known to affect PSA (including ADT) for prostate cancer within 6 months (exception: ADT started due to oligometastatic disease within 2 weeks of study entry) 3. Patient eligible for other treatment (e.g., early docetaxel) than standard treatment described in the protocol as judged by treating physician 4. Life expectancy \<3 years by any reason, including concomitant or previous malignancies 5. Previous radiotherapy or surgery that may interfere with the planned treatment (including intra-prostatic recurrence if previous RT to the prostate) 6. \> 3 PSMA-PET/CT positive target lesions (excluding the prostate and regional lymph node metastasis in de novo patients or prostate bed and or regional lymph node metastasis in recurrent patients) 7. PSMA-PET verified metastases other than skeletal or lymph nodes 8. Metastases in base of scull and/or calotte 9. Any target lesions not treatable with image guided RT (IGRT) due to overlap with previous RT fields or exceeded dose constraint to OAR(s) as specified in study protocol

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma prostate carcinoma

As listed by the trial registrant

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

Positron emission tomography Prostate cancer metastatic Radiation therapy

How to take part

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

  1. The places running it

    7 sites. 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

  • Capio St Göran Hospital

    RECRUITING

    Stockholm, Region Stockholm, Sweden

  • Karolinska University Hospital

    RECRUITING

    Stockholm, Stockholm County, Sweden

  • Region Skåne

    RECRUITING

    Lund, Lund, Sweden

  • Region Örebro Län

    RECRUITING

    Örebro, Örebro County, Sweden

  • Ryhovs county hospital

    RECRUITING

    Jönköping, Sweden

  • Södersjukhuset

    RECRUITING

    Stockholm, Region Stockholm, Sweden

  • Umeå University hospital

    RECRUITING

    Umeå, Umea, 90331, Sweden

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