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Castration-resistant Prostate CancerPhase 3MEDCARENCT06585007

Metastasis-directed Therapy in Oligoprogressive Castration-refractory Prostate Cancer

A Phase 3 study testing Radiotherapy and metastasectomy in people with Castration-resistant Prostate Cancer and Oligoprogressive, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Recruiting

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

Sites and contacts
Official record
Search all trials

Trial summary

Evaluation of the impact of metastasis-directed therapy in patients with castration-refractory prostate cancer and a maximum of 5 progressive lesions. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Radiotherapy and metastasectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
246 participants
Where
1 siteBelgium
Study dates
19 Dec 2023to 20 Jan 2029
Phase
Phase 3
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

  • Participants eligible for inclusion in this Trial must meet all the following criteria:
  • Written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
  • Acinar adenocarcinoma (inclusive neuro-endocrine dedifferentiation).
  • Oligoprogressive disease on conventional imagine within a maximum of 6 weeks prior to randomisation defined as: a maximum of 3 extracranial progressive lesions (pre-existing lesions, the development of new lesions, or both) in any organ. Nodal (N1) disease should be measured in the short axis. Nodes more than 1.5 cm in the short axis are considered pathologic and measurable. Oligoprogression on bone scan is defined as the occurrence of maximal 3 new and/or progressive lesions. In case of not unambiguously, additional imaging such as diagnostic magnetic resonance imaging (MRI) or dedicated CT-scan should be performed. Visceral disease reported separately (lung, liver, adrenal, or CNS) and is considered measurable if an individual lesions is more than 1 cm longest dimension.
  • In case of locally persistent/recurrent disease, a diagnostic MRI of the prostate (bed) and/or biopsy of the site is recommended. There are two different mCRPC patient groups who are eligible for inclusion in the trial:
  • Patients with oligoprogressive disease with pADT only as ongoing treatment (Type 1).
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  • Patients with oligoprogressive disease with pADT +/- second line systemic therapy. This is both the combination of pADT + ARTA as ongoing treatment or patients who had received docetaxel in the past (Type 2).
  • Castration-refractory disease, defined as testosterone level < 50 ng/dL.
  • Prior treatment of the primary tumor by radiotherapy or surgery. If the primary tumor has not been treated previously, this treatment is obligatory within the trial.
  • WHO performance 0-2
  • Age >= 18 years old
  • Absence of psychological, sociological, or geographical condition potentially hampering compliance with study protocol.
  • Patients must be presented at the multidisciplinary board meeting and the inclusion in the trial needs approval by this board.

Who cannot join

  • Ductal adenocarcinoma and small-cell prostate cancer.
  • Serum testosterone level > 50 ng/ml.
  • Presence of poly-progressive disease, defined as more than 3 progressive lesions on conventional imaging or nodal and/or metastatic lesions on conventional imaging
  • Active malignancy other than prostate cancer that could potentially interfere with the interpretation of this trial.
  • Previous treatments (RT, surgery) or comorbidities rendering new treatment with SBRT impossible.
  • Spinal bone lesion that is highly symptomatic, neurologically threatening or at risk of fracture.
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  • Patients already treated with radionuclides, cabazitaxel or PARP-inhibitors in the past.
  • Patients with progressive disease while receiving docetaxel.
  • Not able to understand the treatment protocol or sign informed consent.

Trial locations and contacts

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

Kato Rans, MD contact

003216347600

kato.rans@uzleuven.be

Gert De Meerleer, MD, PhD contact

003216347600

gert.demeerleer@uzleuven.be

Belgium1 site, 1 recruiting

  • University Hospitals Leuven

    Leuven

    Kato Rans, MD, 003216340110, kato.rans@uzleuven.be

    Gert De Meerleer, MD, PhD, 003216347600, gert.demeerleer@uzleuven.be

    Recruiting

Other trials in Belgium

About this study

Official title: Metastasis-directed Therapy in Oligoprogressive Castration-refractory Prostate Cancer: a Randomized Phase 3 Trial

Evaluation of the impact of metastasis-directed therapy in patients with castration-refractory prostate cancer and a maximum of 5 progressive lesions.

Read the detailed description

MEDCARE phase 3 trial is approved by the central Ethics committee. It is a multicentric, randomized, prospective, open-label, two-arm, phase III trial. The aim is to evaluate the impact of progression-directed therapy (PDT) in patients presenting with oligoprogressive mCRPC on overall survival (OS). The study will employ a 1:1 randomization between arm A and arm B. Patients will be stratified according to number of metastases (1 versus > 1), initial localization (local recurrence, N or M1a vs. M1b or M1c) and systemic therapy (patient type 1 vs. type 2, see below) (Fig 1). Randomization will be carried out after approval in the multidisciplinary tumour board were the standard-of-care treatment and kind of PDT (metastasectomy or SBRT) will be decided before randomization.

Being tested
Radiotherapy, metastasectomy

What participants receive

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

  • RadiotherapyRadiation

    Progression-directed therapy (stereotactic body radiation therapy)

  • metastasectomyProcedure or surgery

    Progression-directed therapy (metastasectomy)

Study groups in NCT06585007
Study groupRoleWhat they receive
Standard of care therapyNo interventionThe standard of care can consist of surveillance (which means the continuation of the ongoing systemic treatment without any change) or initiation of NEST. The decision which option is considered must be decided at the multidisciplinary urologic oncology meeting (obligatory). MDT is not allowed in this arm. Options for NEST in this trial are abiraterone acetate, enzalutamide, apalutamide, darolutamide, olaparib, talazoparib, niraparib, cabazitaxel and docetaxel, radium-223, luthetium-177-PSMA.
Progression-directed therapyExperimentalPDT (metastasectomy or SBRT) while continuing current systemic therapy: androgen-deprivation (ADT) alone, or ADT in combination with abiraterone acetate, enzalutamide, apalutamide and patients who had received docetaxel in the past. Patients under current treatment with docetaxel are not allowed, because the hypothesized interaction between docetaxel and radiotherapy concerning toxicity. In case of oligoprogression after PDT, repeated PDT to the new lesions is mandatory.
Receives: Radiation: Radiotherapy; Procedure: metastasectomy

What is being measured

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

  1. Overall Survival

    Overall Survival

    Measured: will be calculated from the day of randomisation until death from any cause, wichever came first, assessed up to 5 years.

Secondary outcomes (6)

  1. Quality of life scoring EORTC QLQ-C30

    Quality of life scoring using the EORTC QLQ-C30

    Measured: Assessments are planned at baseline and during follow-up consultation at month 1, month 3, month 6, month 12 and month 24

  2. Quality of life scoring EORTC QLQ-PR25

    Quality of life scoring using the EORTC QLQ-PR25

    Measured: Assessments are planned at baseline and during follow-up consultation at month 1, month 3, month 6, month 12 and month 24

  3. Quality of life scoring EQ-5D-5L

    Quality of life scoring using the EQ-5D-5L.

    Measured: Assessments are planned at baseline and during follow-up consultation at month 1, month 3, month 6, month 12 and month 24

  4. Cancer Specific Survival

    Cancer Specific Survival

    Measured: will be calculated from the day of randomisation until prostate cancer death, assessed up to 5 years.

  5. Radiographic progression free survival

    Radiographic progression free survival

    Measured: will be calculated from the day of randomisation until the first day of progression (local, nodal or metastatic). Imaging is performed every 6 months during follow-up or at any time in case of PSA progression or symptoms, assessed up to 5 years.

  6. Progression-directed therapy induced acute or late toxicity scoring

    Acute and late toxicity as a result of radiotherapy will be scored using the Common Toxicity Criteria Version 5.0 and metastasectomy related toxicity will be scored using Clavien Dindo scoring system.

    Measured: Toxicity will be scored every follow-up visit, assessed up to 5 years after progression-directed therapy.

Timeline

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

  1. First posted5 Sep 2024
  2. Study start19 Dec 2023
  3. Primary completion20 Jan 2029 (estimated)
  4. Study completion20 Jan 2029 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
246 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06585007
Sponsor's protocol ID
S67130
Other IDs
2022-502254-13-00
Acronym
MEDCARE
Status last verified
Apr 2024
First submitted
22 Apr 2024
Last updated
5 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radiotherapy and metastasectomy in people with Castration-resistant Prostate Cancer and Oligoprogressive, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

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 13 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 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Kato Rans, MD (003216347600, kato.rans@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: will be calculated from the day of randomisation until death from any cause, wichever came first, assessed up to 5 years.). 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 NCT06585007.

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 5 Sep 2024.

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