Prostate CancerPhase 3SPARKLENCT05352178
Metastasis-directed Therapy for Oligorecurrent Prostate Cancer
A Phase 3 study testing Radiotherapy (SBRT) and/or surgery (metastasectomy), Androgen deprivation therapy and Androgen receptor targeted therapy in people with Prostate Cancer and Prostate Cancer Recurrent, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The aim is to investigate whether the addition of short-term androgen deprivation therapy (ADT) during 1 month or short-term ADT during 6 months together with an androgen receptor targeted therapy (ARTA) to metastasis-directed therapy (MDT) significantly prolongs poly-metastatic free survival (PMFS) and/or metastatic… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer Recurrent, Prostate Cancer Metastatic
- What is being tested?
- Radiotherapy (SBRT) and/or surgery (metastasectomy), Androgen deprivation therapy and Androgen receptor targeted therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 873 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Apr 2022to 25 Apr 2032
- 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
- Histologically proven initial diagnosis of prostate adenocarcinoma
- Priory treated and controlled primary tumor
- Biochemical recurrence defined by prostate-specific antigen (PSA) values >0,2 ng/ml (i.e., two consecutive increases) following radical prostatectomy + postoperative radiotherapy and a PSA value of 2 ng/ml above the nadir after high-dose RT.
- Oligorecurrent disease defined as a maximum of 5 extracranial metastases in any organ, diagnosed on PSMA PET-CT or PSMA PET-MRI reported according to the E-PSMA consensus guidelines for interpretation of PSMA-PET (26). Nodal (N1) disease can be included only when accompanied by M1a-c disease, provided that the total number of spots does not exceed 5.
- Serum testosterone level within normal range.
- WHO performance 0-2
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- 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.
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- 2. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
Who cannot join
- Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- Serum testosterone level at castration level.
- PSA rise while on active treatment (LHRH-agonist, LHRH antagonist, anti-androgen, maximal androgen blockade, oestrogen)
- Presence of poly-metastatic disease, defined as more than 5 metastatic lesions.
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- 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.
- Contra indications for intake of enzalutamide (seizure or any condition that may predispose to seizure; significant cardiovascular disease within the last three months including myocardial infarction, unstable angina, congestive heart failure, ongoing arrythmias of grade > 2 or a thromboembolic event).
- 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.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven
Kato Rans, MD, 003216340110, kato.rans@uzleuven.be
Gert De Meerleer, MD, PhD, 003216347600, gert.demeerleer@uzleuven.be
About this study
Official title: a New Spark in Treating Oligorecurrent Prostate Cancer: Adding Systemic Treatment to Stereotactic Body Radiotherapy or Metastasectomy: Key to Long-lasting Event-free Survival?
The aim is to investigate whether the addition of short-term androgen deprivation therapy (ADT) during 1 month or short-term ADT during 6 months together with an androgen receptor targeted therapy (ARTA) to metastasis-directed therapy (MDT) significantly prolongs poly-metastatic free survival (PMFS) and/or metastatic castration-refractory prostate cancer free survival (mCRPC-FS) in patients with oligorecurrent hormone sensitive prostate cancer.
Read the detailed description
Metastasis-directed therapy (MDT) has broadened the therapeutic window in patients presenting with oligorecurrent prostate cancer as it postpones the initiation of palliative androgen deprivation therapy (pADT) and its substantial side-effects for several years. Also from a biological point of view, this might be beneficial as the (early) use of ADT promotes the development of the lethal castrate-resistant state, whereby metastatic progression is driven by androgen-independent pathways. Metastasis-directed therapy with stereotactic body radiotherapy (SBRT) or surgery has shown to be able to eradicate metastases with a significant advantage concerning the pADT-free survival compared to active surveillance. And the combination of SBRT with palliative systemic treatment significantly improved overall survival (OS) when compared tot systemic treatment alone.
One of the largest retrospective analyses (191 patients) on MDT for oligorecurrent prostate cancer has been conducted previously at UZ Leuven (doi: 10.3390/cancers12082271). Estimated median pADT-free survival was 66 months and estimated median mCRPC-free survival was not reached, but 83% of patients were still free of mCRPC at 10 years.
The addition of ADT to primary radiotherapy for intermediate of high risk prostate cancer or to salvage radiotherapy has shown to improve overall survival. Within the context of SBRT for oligorecurrent disease it is not yet known whether the addition of a certain period of ADT prolongs CRPC-free survival and if so, what should be the optimal duration of this ADT administration. Moreover, the addition of an androgen receptor targeted agent (ARTA) to ADT in men with metastatic hormone sensitive prostate cancer and a treated primary tumor resulted in significantly improved clinical outcomes, also in low-volume metastatic disease.
In this clinical trial the aim is to investigate whether the addition of short-term ADT during 1 month or short-term ADT during 6 months together with an ARTA to MDT significantly prolongs poly-metastatic free survival (PMFS) and/or metastatic castration-refractory prostate cancer free survival (mCRPC-FS) in patients with oligorecurrent hormone sensitive prostate cancer.
- Conditions
- Prostate Cancer, Prostate Cancer Recurrent, Prostate Cancer Metastatic, Metastatic Cancer, Oligometastatic Disease, Oligometastasis
- Being tested
- Radiotherapy (SBRT) and/or surgery (metastasectomy), Androgen deprivation therapy, Androgen receptor targeted therapy
- Keywords
- Androgen deprivation therapy, Androgen receptor targeted agent, Stereotactic body radiation therapy, Metastasis-directed therapy
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy (SBRT) and/or surgery (metastasectomy)Other
Metastasis-directed therapay (surgery and/or radiotherapy) as treatment for oligorecurrent lesions
Androgen deprivation therapyDrug
Arm B: gosereline 3.6 mg sc, leuproreline 7.5 mg sc, triptoreline 3.75 mg im Arm C: gosereline 3.6 mg sc 1x/month or gosereline 10.8 mg sc or leuproreline 7.5 mg sc 1x/month or leuproreline 45 mg sc or triptoreline 3.75 mg im 1x/month or triptoreline 11.5 mg im 1x/3months or triptoreline 22.5 mg im
Androgen receptor targeted therapyDrug
Enzalutamide
| Study group | Role | What they receive |
|---|---|---|
| MDT alone | Active comparator | Metastasis-directed therapy alone Receives: Other: Radiotherapy (SBRT) and/or surgery (metastasectomy) |
| MDT + 1 month of ADT | Experimental | Metastasis-directed therapy plus one month of androgen deprivation therapy (gosereline 3.6 mg sc, leuproreline 7.5 mg sc, triptoreline 3.75 mg im) Receives: Other: Radiotherapy (SBRT) and/or surgery (metastasectomy); Drug: Androgen deprivation therapy |
| MDT + 6 months of ADT + anzalutamide | Experimental | Metastasis-directed therapy plus 6 months of androgen deprivation therapy (gosereline 3.6 mg sc 1x/month or gosereline 10.8 mg sc or leuproreline 7.5 mg sc 1x/month or leuproreline 45 mg sc or triptoreline 3.75 mg im 1x/month or triptoreline 11.5 mg im 1x/3months or triptoreline 22.5 mg im) and enzalutamide (4 x 40 mg each day during 6 months ) Receives: Other: Radiotherapy (SBRT) and/or surgery (metastasectomy); Drug: Androgen deprivation therapy; Drug: Androgen receptor targeted therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Poly-metastatic free survival (PMFS)
from the last day of MDT until the first day of poly-progression which is defined as the detection > 5 new lesions at PSMA PET-CT or PSMA PET-MRI (+/- combined with MRI if needed to improve diagnostic accuracy). In case of poly-progression, pADT will be considered the standard-of-care. Other indications to start pADT are local progression of an irradiated site and/or or clinical symptoms caused by local progression. In all cases, the initiation of pADT will only be carried out after approval of the multidisciplinary tumor board. Any decision to start with pADT will be reported with date and specific reason. If recurrence occurs in 5 lesions or less a new MDT is proposed if technically feasible.
Measured: up to 5 years after MDT
Secondary outcomes (7)
Metastatic castration-refractory prostate cancer free survival (mCRPC-FS)
mCRPC-FS will be calculated from the last day of MDT until the first day of diagnosis of castration-resistant prostate cancer (CRPC). CRPC is defined according to the contemporary EAU-guidelines as the time to biochemical and/or clinical progression at castrate testosterone levels (< 50 ng/dl). Biochemical progression is defined as three consecutive PSA rises (1 week interval), of which at least 2 rises with a PSA level of > 2 ng/ml and a rise of 50% above the nadir PSA level
Measured: up to 5 years after MDT
Biochemical progression-free survival (bPFS)
bPFS will be calculated from the last day of MDT until the first day of biochemical relapse (BcR). BcR is defined as three consecutive PSA rises (1 week interval), of which at least 2 rises with a PSA level of > 2 ng/ml and a rise of 50% above the nadir PSA level.
Measured: up to 5 years after MDT
Clinical progression free survival (cPFS)
cPFS will be calculated from the last day of MDT until the first day of progression (local, nodal or metastatic) on PSMA PET-CT or PSMA PET-MRI. Imaging is performed in case of BcR, defined as above. Progression on PSMA PET-CT or PSMA PET-MRI will be defined as in the consensus statements on PSMA PET-CT or PSMA PET-MRI response assessment criteria in prostate cancer:
- the appearance of 2 or more new PSMA PET-CT or PSMA PET-MRI lesions or increase of uptake or tumor PET volume of at least 30%.
- OR the appearance of 1 new lesion with a high suspicion on PSMA PET-CT or PSMA PET-MRI
Measured: up to 5 years after MDT
Cancer Specific Survival (CSS)
Cancer specific survival (CSS) will be calculated from last day of treatment until PCa death.
Measured: up to 10 years after MDT
Overall Survival (OS)
Overall survival (OS) will be calculated from last day of treatment until death from any cause.
Measured: up to 10 years after MDT
Acute and late toxicity scoring
Acute and late toxicity as a result of radiotherapy will be scores using the Common Toxicity Criteria Version 5.0 (30).
Measured: up to 5 years after MDT
Quality of life (QOL)
Quality of life scoring using the EORTC QLQ-C30 supplement with QLQ-PR25. We will assess the quality-of-life-years with the EuroQOL classification system (EQ-5D-5L). Assessments are planned at baseline, last day of treatment, and during follow-up consultation at month M1, M3, M6, M12 and M24
Measured: up to 5 years after MDT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start20 Apr 2022
- Primary completion25 Apr 2027 (estimated)
- Study completion25 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Randomized, three-arm, phase III trial
- Masking
- None (open label)
- Enrolment
- 873 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352178
- Sponsor's protocol ID
- S65935
- Other IDs
- 2022-000066-18
- Acronym
- SPARKLE
- Status last verified
- Jul 2024
- First submitted
- 22 Apr 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rans K, Charlien B, Filip A, Olivier H, Julie DH, Cederic D, Herlinde D, Benedikt E, Karolien G, Annouschka L, Nick L, Kenneth P, Carl S, Koen S, Hans V, Ben V, Steven J, Gert M. SPARKLE: a new spark in treating oligorecurrent prostate cancer: adding systemic treatment to stereotactic body radiotherapy or metastasectomy: key to long-lasting event-free survival? BMC Cancer. 2022 Dec 12;22(1):1294. doi: 10.1186/s12885-022-10374-0.
PubMed 36503429
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a New Spark in Treating Oligorecurrent Prostate Cancer: Adding Systemic Treatment to Stereotactic Body Radiotherapy or Metastasectomy: Key to Long-lasting Event-free Survival?
- ClinicalTrials.gov ID
- NCT05352178
- Acronym / sponsor ID
- SPARKLE / S65935
- Conditions
- Prostate Cancer, Prostate Cancer Recurrent, Prostate Cancer Metastatic, Metastatic Cancer, Oligometastatic Disease, Oligometastasis
- Keywords
- Androgen deprivation therapy, Androgen receptor targeted agent, Stereotactic body radiation therapy, Metastasis-directed therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 873 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 25 Apr 2027 (estimated)
- Study completion
- 25 Apr 2032 (estimated)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to investigate whether the addition of short-term androgen deprivation therapy (ADT) during 1 month or short-term ADT during 6 months together with an androgen receptor targeted therapy (ARTA) to metastasis-directed therapy (MDT) significantly prolongs poly-metastatic free survival (PMFS) and/or metastatic castration-refractory prostate cancer free survival (mCRPC-FS) in patients with oligorecurrent hormone sensitive prostate cancer.
Detailed description
Metastasis-directed therapy (MDT) has broadened the therapeutic window in patients presenting with oligorecurrent prostate cancer as it postpones the initiation of palliative androgen deprivation therapy (pADT) and its substantial side-effects for several years. Also from a biological point of view, this might be beneficial as the (early) use of ADT promotes the development of the lethal castrate-resistant state, whereby metastatic progression is driven by androgen-independent pathways. Metastasis-directed therapy with stereotactic body radiotherapy (SBRT) or surgery has shown to be able to eradicate metastases with a significant advantage concerning the pADT-free survival compared to active surveillance. And the combination of SBRT with palliative systemic treatment significantly improved overall survival (OS) when compared tot systemic treatment alone.
One of the largest retrospective analyses (191 patients) on MDT for oligorecurrent prostate cancer has been conducted previously at UZ Leuven (doi: 10.3390/cancers12082271). Estimated median pADT-free survival was 66 months and estimated median mCRPC-free survival was not reached, but 83% of patients were still free of mCRPC at 10 years.
The addition of ADT to primary radiotherapy for intermediate of high risk prostate cancer or to salvage radiotherapy has shown to improve overall survival. Within the context of SBRT for oligorecurrent disease it is not yet known whether the addition of a certain period of ADT prolongs CRPC-free survival and if so, what should be the optimal duration of this ADT administration. Moreover, the addition of an androgen receptor targeted agent (ARTA) to ADT in men with metastatic hormone sensitive prostate cancer and a treated primary tumor resulted in significantly improved clinical outcomes, also in low-volume metastatic disease.
In this clinical trial the aim is to investigate whether the addition of short-term ADT during 1 month or short-term ADT during 6 months together with an ARTA to MDT significantly prolongs poly-metastatic free survival (PMFS) and/or metastatic castration-refractory prostate cancer free survival (mCRPC-FS) in patients with oligorecurrent hormone sensitive prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized, three-arm, phase III trial
| Arm | Type | Receives |
|---|---|---|
| MDT alone | Active comparator | Other: Radiotherapy (SBRT) and/or surgery (metastasectomy)Metastasis-directed therapy alone |
| MDT + 1 month of ADT | Experimental | Other: Radiotherapy (SBRT) and/or surgery (metastasectomy), Drug: Androgen deprivation therapyMetastasis-directed therapy plus one month of androgen deprivation therapy (gosereline 3.6 mg sc, leuproreline 7.5 mg sc, triptoreline 3.75 mg im) |
| MDT + 6 months of ADT + anzalutamide | Experimental | Other: Radiotherapy (SBRT) and/or surgery (metastasectomy), Drug: Androgen deprivation therapy, Drug: Androgen receptor targeted therapyMetastasis-directed therapy plus 6 months of androgen deprivation therapy (gosereline 3.6 mg sc 1x/month or gosereline 10.8 mg sc or leuproreline 7.5 mg sc 1x/month or leuproreline 45 mg sc or triptoreline 3.75 mg im 1x/month or triptoreline 11.5 mg im 1x/3months or triptoreline 22.5 mg im) and enzalutamide (4 x 40 mg each day during 6 months ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically proven initial diagnosis of prostate adenocarcinoma
- Priory treated and controlled primary tumor
- Biochemical recurrence defined by prostate-specific antigen (PSA) values >0,2 ng/ml (i.e., two consecutive increases) following radical prostatectomy + postoperative radiotherapy and a PSA value of 2 ng/ml above the nadir after high-dose RT.
- Oligorecurrent disease defined as a maximum of 5 extracranial metastases in any organ, diagnosed on PSMA PET-CT or PSMA PET-MRI reported according to the E-PSMA consensus guidelines for interpretation of PSMA-PET (26). Nodal (N1) disease can be included only when accompanied by M1a-c disease, provided that the total number of spots does not exceed 5.
- Serum testosterone level within normal range.
Key exclusion criteria (10 listed)
- Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- Serum testosterone level at castration level.
- PSA rise while on active treatment (LHRH-agonist, LHRH antagonist, anti-androgen, maximal androgen blockade, oestrogen)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiotherapy (SBRT) and/or surgery (metastasectomy)Metastasis-directed therapay (surgery and/or radiotherapy) as treatment for oligorecurrent lesions | Other | MDT + 1 month of ADT, MDT + 6 months of ADT + anzalutamide, MDT alone |
| Androgen deprivation therapyArm B: gosereline 3.6 mg sc, leuproreline 7.5 mg sc, triptoreline 3.75 mg im Arm C: gosereline 3.6 mg sc 1x/month or gosereline 10.8 mg sc or leuproreline 7.5 mg sc 1x/month or leuproreline 45 mg sc or triptoreline 3.75 mg im 1x/month or triptoreline 11.5 mg im 1x/3months or triptoreline 22.5 mg im | Drug | MDT + 1 month of ADT, MDT + 6 months of ADT + anzalutamide |
| Androgen receptor targeted therapyEnzalutamide | Drug | MDT + 6 months of ADT + anzalutamide |
Primary outcome
Poly-metastatic free survival (PMFS)
Time frame: up to 5 years after MDT
from the last day of MDT until the first day of poly-progression which is defined as the detection > 5 new lesions at PSMA PET-CT or PSMA PET-MRI (+/- combined with MRI if needed to improve diagnostic accuracy). In case of poly-progression, pADT will be considered the standard-of-care. Other indications to start pADT are local progression of an irradiated site and/or or clinical symptoms caused by local progression. In all cases, the initiation of pADT will only be carried out after approval of the multidisciplinary tumor board. Any decision to start with pADT will be reported with date and specific reason. If recurrence occurs in 5 lesions or less a new MDT is proposed if technically feasible.
7 secondary outcomes
Metastatic castration-refractory prostate cancer free survival (mCRPC-FS)
Time frame: up to 5 years after MDT
Biochemical progression-free survival (bPFS)
Time frame: up to 5 years after MDT
Clinical progression free survival (cPFS)
Time frame: up to 5 years after MDT
Cancer Specific Survival (CSS)
Time frame: up to 10 years after MDT
Overall Survival (OS)
Time frame: up to 10 years after MDT
Acute and late toxicity scoring
Time frame: up to 5 years after MDT
Quality of life (QOL)
Time frame: up to 5 years after MDT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 36503429Rans K, Charlien B, Filip A, Olivier H, Julie DH, Cederic D, Herlinde D, Benedikt E, Karolien G, Annouschka L, Nick L, Kenneth P, Carl S, Koen S, Hans V, Ben V, Steven J, Gert M. SPARKLE: a new spark in treating oligorecurrent prostate cancer: adding systemic treatment to stereotactic body radiotherapy or metastasectomy: key to long-lasting event-free survival? BMC Cancer. 2022 Dec 12;22(1):1294. doi: 10.1186/s12885-022-10374-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiotherapy (SBRT) and/or surgery (metastasectomy), Androgen deprivation therapy and Androgen receptor targeted therapy in people with Prostate Cancer and Prostate Cancer Recurrent, 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 11 inclusion and 10 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 3 Jul 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 (003216340110, kato.rans@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Poly-metastatic free survival (PMFS) (time frame: up to 5 years after MDT). 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 NCT05352178, 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 3 Jul 2024.