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Prostate Cancer MetastaticMETRONCT04983095

Metastasis Directed Stereotactic Body Radiotherapy for Oligo Metastatic Hormone Sensitive Prostate Cancer

A study testing stereotactic body radiotherapy, androgen deprivation therapy and Radiotherapy in people with Prostate Cancer Metastatic and Radiation Therapy, run by Karin Soderkvist at 7 sites in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The study is an open label, multi-centre, randomized phase III study. The patients will be randomised in a 1:1 ratio to treatment consisting of Arm A: MD-SBRT in addition to standard treatment Arm B: Standard treatment Study population: Patients with hormone sensitive prostate cancer (HSPC) with oligometastatic… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
stereotactic body radiotherapy, androgen deprivation therapy and Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
7 sitesSweden
Study dates
27 Oct 2021to Dec 2033
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed prostate cancer (ICD-O-3 C61)
  • WHO/ECOG performance status 0-1
  • 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
  • Willing and able to provide informed consent-

Who cannot join

  • Castration resistant prostate cancer (progression with castrate levels of testosterone)
  • 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)
  • Patient eligible for other treatment (e.g., early docetaxel) than standard treatment described in the protocol as judged by treating physician
  • Life expectancy <3 years by any reason, including concomitant or previous malignancies
  • Previous radiotherapy or surgery that may interfere with the planned treatment (including intra-prostatic recurrence if previous RT to the prostate)
  • > 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)
Show all 9Show fewer
  • PSMA-PET verified metastases other than skeletal or lymph nodes
  • Metastases in base of scull and/or calotte
  • 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

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Karin Söderkvist, MD,PhD contact

+46 90 7853222

karin.soderkvist@umu.se

7 sites in 1 country

Sweden7 sites, 7 recruiting

  • Ryhovs county hospital

    Jönköping

    Kirsten Bjornlinger, M.D, Kirsten.bjornlinger@rjl.se

    Recruiting

  • Region Skåne

    Lund, Lund

    Adalsteinn Gunnlaugsson, Senior Consultant, adalsteinn.gunnlaugsson@skane.se

    Recruiting

  • Region Örebro Län

    Örebro, Örebro County

    Jenny Kahlmeter-Brandell, Senior Consultant, jenny.kahlmeter-brandell@regionorebrolan.se

    Recruiting

  • Capio St Göran Hospital

    Stockholm, Region Stockholm

    Martina Westin, Senior Consultant, martina.westin@capiostgoran.se

    Recruiting

  • Södersjukhuset

    Stockholm, Region Stockholm

    Chunde Li, Senior Consultant, chunde.li@regionstockholm.se

    Recruiting

  • Karolinska University Hospital

    Stockholm, Stockholm County

    Mattias Hedman, MD, mattias.hedman@regionstockholm.se

    Recruiting

  • Umeå University hospital

    Umeå, Umea, 90331

    Karin Söderkvist, 0705282558, karin.soderkvist@umu.se

    Recruiting

Other trials in Sweden

About this study

The study is an open label, multi-centre, randomized phase III study. The patients will be randomised in a 1:1 ratio to treatment consisting of

  • Arm A: MD-SBRT in addition to standard treatment
  • Arm B: Standard treatment
Read more

Study population: Patients with hormone sensitive prostate cancer (HSPC) with oligometastatic disease detected by PSMA-PET/DT. This includes patients with de novo oligometastatic HSPC and recurrent HSPC after primary RT or prostatectomy.

Primary endpoint: Failure free survival

Secondary endpoints:

  • Predictive value of investigated biomarkers in blood and imaging
  • Acute and late toxicity after MD-SBRT
  • PROM at 3 months, 1, 3 and 5 years
  • Castration resistant prostate cancer, CRPC
  • Overall survival
  • Differences in outcome between patients by strata

Stratification: To avoid imbalance between treatment arms the minimisation method will be used to achieve balance between de novo oligo-metastatic and oligo-recurrent patients, as well as treatment site.

Safety evaluation: Adverse events and side effects graded according to CTCAE v5.0 will be collected every 6th month. Serious Adverse Events are to be reported within 24 hours throughout the study duration.

Statistical methods: Survival endpoints will be calculated using the Kaplan-Meier method with differences compared using the stratified log-rank test. Randomization time is set as baseline time. Pre-planned subgroup analysis will occur based on pre-specified stratification variables. A Cox multivariable regression model will be used to determine factors predictive of survival. Safety analysis will be performed with Mann-Whitney U-test or Fishers exact test.

Criteria for evaluation: Per protocol (patients that have started study treatment) and Intention to treat (all included patients).

Planned sample size: 118 patients

Analysis plan:

The primary end point will be analysed after pre-specified number of events have occurred. All patients randomised to SBRT will be followed minimum 60 months for toxicity. Safety analysis of acute toxicity will take place after median follow up of 6 months. Safety analysis of late toxicity will be analysed after study closure.

Duration of the study:

Three to five years inclusion. 72 months of follow-up after randomization of the last patient.

Read the detailed description

Standard of Care (arm A and B): 3 years of ADT with the addition of abiraterone+prednisolone for two years. If the patient is de novo oligo-metastatic, RT to the prostate +/- pelvic fields is considered as standard treatment.

Study intervention (arm A): MD-SBRT to all PSMA-PET/CT positive metastatic target volume(s) with 30 Gy in 3 fractions or 40 Gy in 5 fractions in addition to SoC. For recurrent patients post prostatectomy with PSMA-PET-positive finding at prostate bed +/- regional lymph nodes (without prior local RT) salvage RT +/-pelvic fields with SIB to the PSMA+ GTV is to be delivered (sum of SBRT-targets maximum 3).

Screening procedure:Inclusion/exclusion criteria evaluation including evaluation of feasibility of SBRT to all positive lesions on PSMA-PET/CT performed within approx. 30 days of randomization.

Study specific procedure: Recording/collecting of baseline data including baseline PROM and pre-ADT testosterone and PSA. Standard treatment with ADT administered at randomization to all study patients. Abiraterone is initiated within 8 weeks of study entry. Start of MD-SBRT within approx. 28 days of randomization to patients in arm A. Additional RT as specified in study intervention started within 90 days. Follow up according to protocol, minimum 60 months.

Being tested
stereotactic body radiotherapy, androgen deprivation therapy, Radiotherapy
Keywords
Oligometastatic Prostate Cancer, Hormone Sensitive, Stereotactic Body Radiotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • stereotactic body radiotherapyRadiation

    Also called stereotactic ablative radiotherapy, image guided radiotherapy

    30 Gy in 3 fractions alternatively 40 Gy in 5 fractions delivered with stereotactic radiotherapy-principles

  • androgen deprivation therapyCombination product

    Also called gonadotropin releasing hormone-agonist, gonadotropin releasing hormone-antagonist, androgen-receptor pathway inhibitor (ARPI)

    Medical castration and next-generation Hormonal Agent along with radiotherapy to the prostate in de novo oligometastatic prostate cancer

  • RadiotherapyRadiation

    Also called external radiotherapy

    RT to the prostate for de novo patients

Study groups in NCT04983095
Study groupRoleWhat they receive
Standard of CareActive comparatorADT+ARPI to all patients and local RT +/- pelvic fields to de novo patients
Receives: Combination Product: androgen deprivation therapy; Radiation: Radiotherapy
SBRT+Standard of CareExperimentalSBRT to all PSMA+ lesions in addition to SoC and salvage RT to the prostate bed +/- pelvic fields if recurrent post prostatectomy and PSMA-PET+ in the pelvis
Receives: Radiation: stereotactic body radiotherapy; Combination Product: androgen deprivation therapy; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Failure free survival

    Time from randomisation to progressive disease. Progression is defined as 2 consecutive rises in blood PSA. PSA will be collected every third month and registered in the electronic case report form.

    Measured: Throughout the study duration (72 months of follow up for last patient included.)

Secondary outcomes (6)

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.

    Side effects according to Common Terminology Criteria for Adverse Events version 5, CTCAE v5 will be collected at baseline, 3 and 6 months after randomisation for all organs at risk within 3 cm from the SBRT-target in the electronic case report form. Adverse events are scored from 0 (none) to 5 (fatal) in the electronic case report form. We will report the number of patients with no reported side effects as well as the number of patients scoring 1, 2, 3, 4 and 5 assessed by CTCAE v5.

    Measured: Until 6 months after randomisation

  2. Number of participants with treatment-related serious adverse events as assessed by CTCAE v5.

    Side effects grade 4 or higher according to Common Terminology Criteria for Adverse Events version 5, CTCAE v5 will be collected every 6th months after randomisation for all organs at risk within 3 cm from the SBRT-target. Adverse events are scored from 0 (none) to 5 (fatal) are collected in the electronic case report form. We will report the number of patients with no reported side effects as well as the number of patients scoring 1, 2, 3, 4 and 5 assessed by CTCAE v5.

    Measured: Throughout the study duration (72 months of follow up for last patient included.)

  3. Outcome prediction

    Blood samples will be collected to enable evaluation of circulating biomarkers in relation to patient response to treatment at baseline, 1 and 3 months after randomisation, and at progression. Specifically, plasma will be sampled and circulating tumor cells and platelets will be further isolated. Imaging parameters from the baseline PSMA-PET/CT will also be evaluated in relation to outcome.

    Measured: Throughout the study duration (72 months of follow up for last patient included.)

  4. Patient reported quality of life assessed by EORTC-QLQ 30

    Patients will fill out a cross validated self registration questionnaire; European Organistaion for Research and Treatment of Cancer Quality of Life Questionnaire, EORTC QLQ 30, at baseline, 3 months, year 1, 3 and 5. The questionnaire consists of 28 statements that are to be graded from 1 (not at all) to 4 (very well) according to how well they correspond to the patients perception. EORTC QLQ30 also ask for the patient to score their overall sense of 1)health and 2)quality of life on a scale from 1 (very poor) to 7 (excellent).

    Measured: Throughout the study duration (72 months of follow up for last patient included.)

  5. Overall survival

    Death due to any cause

    Measured: Throughout the study duration (72 months of follow up for last patient included.)

  6. Castration resistent prostate cancer, CRPC

    2 consecutive rises in blood PSA with castrate levels of testosterone. PSA will be collected every third month and registered in the electronic case report form. Testosterone will be collected if a rise in PSA level is detected.

    Measured: Throughout the study duration (72 months of follow up for last patient included.)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2021
  2. Study start27 Oct 2021
  3. Primary completion31 Dec 2031 (estimated)
  4. Study completionDec 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients are randomised to control (standard care)1:1 intervention (SBRT+standard care)
Masking
None (open label)
Enrolment
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04983095
Sponsor's protocol ID
METRO_vers1
Acronym
METRO
Status last verified
Feb 2026
First submitted
1 Jun 2021
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: SBRT-plans will be shared in detail for all treatment related adverse effects grade\>3 according to CTCAE vers 5 in both final and interim analyses. Study protocol including Statistical Analysis Plan will be made public through per review scientific publication

Publications

  • Soderkvist K, Zia M, Gunnlaugsson A, Josefsson A, Aksnessaether B, Li C, Thellenberg-Karlsson C, Alm D, Kudren D, Lundin E, Moise G, Brandell JK, Kindblom J, Bjornlinger K, Karlsson K, Riklund K, Westin M, Hedman M, Skorve N, Wikstrom P, Strandberg S, Jonsson J. Metastasis-directed SBRT for oligometastatic hormone sensitive prostate cancer (METRO): protocol for a prospective randomised phase III trial, NCT04983095. BMC Cancer. 2026 Mar 25;26(1):456. doi: 10.1186/s12885-026-15906-6.

    PubMed 41882599

Questions about this trial

What is this clinical trial studying?

A study testing stereotactic body radiotherapy, androgen deprivation therapy and Radiotherapy in people with Prostate Cancer Metastatic and Radiation Therapy, run by Karin Soderkvist at 7 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Karin Söderkvist, MD,PhD (+46 90 7853222, karin.soderkvist@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Failure free survival (time frame: Throughout the study duration (72 months of follow up for last patient included.)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04983095, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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