Prostate Cancer (Adenocarcinoma)Phase 2OLYMPIANNCT07038304
The Impact of Metastatic Directed Radiotherapy (MDRT) on Oligoprogressive Castration Resistant Prostate Cancer (CRPC)
A Phase 2 study testing Metastasis directed radiotherapy in people with Prostate Cancer (Adenocarcinoma) and OligoProgressive Metastatic Disease, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial summary
In patients with metastatic prostate cancer (PCa) who receive androgen deprivation therapy (ADT), the sensitivity to castration will eventually disappear due to the selection of castration-refractory clones. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma), OligoProgressive Metastatic Disease, Castration Resistant Metastatic Prostate Cancer
- What is being tested?
- Metastasis directed radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesNetherlands
- Study dates
- 3 Jan 2025to 3 Jan 2029
- Phase
- Phase 2
- 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
- Adenocarcinoma of the prostate.
- mCRPC setting, with testosterone level < 50 ng/dl or 1.7 nmol/l.
- Oligoprogressive disease diagnosed on PSMAscan; defined as the progression of pre-existing metastatic disease, and/or the appearance of new metastases and/or the appearance of a local relapse with a maximum of 3 lesions in total.
- Patients currently treated with ADT, whether combined with another systemic treatment such as ARTA, chemotherapy.
- For patients treated with chemotherapy, the course should be completed or stopped before start MORT - In case of treatment with ARTA, a minimal of 3 months response (PSA or clinical response).
- WHO performance status 0-2.
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- Age > = 18 years old.
- Patiënt should be presented at the multidisciplinary tumor board of the local hospital in which the therapy will be given.
- Before patiënt registration, written informed consent must be given according to ICH/GCO and national/local regulations.
Who cannot join
- Serum testosterone level > 50 ng/ml or > 1.7 nmol/l.
- Presence of more than 3 progressive/new metastatic lesions and/or local recurrence (which counts for 1 lesion).
- Active malignancy other than prostate cancer that can potentially interfere with the interpretation of the trial, except non-melanoma skin cancer or non-invasive urothelial cell carcinoma.
- Local recurrence in the prostate after previous radiotherapy
- Previous treatments (RT, surgery) or comorbidities making new treatment with MDRT impossible.
- Disorder precluding understanding of trial Information or informed consent or signing informed consent.
- Evidence of PSMA-negative disease.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
UMC Groningen
Groningen
Shafak Aluwini, +31625649975, s.al-uwini@umcg.nl
- Not yet recruiting
Radboud Umc
Nijmegen
Robert Jan Smeenk, +31 (024) 361 45 05, RobertJan.Smeenk@radboudumc.nl
About this study
Official title: Oligometastatic Directed Radiotherapy for Patients With Castration Resistant Prostate Cancer
In patients with metastatic prostate cancer (PCa) who receive androgen deprivation therapy (ADT), the sensitivity to castration will eventually disappear due to the selection of castration-refractory clones. This will lead to the stage of metastatic castration-refractory prostate can-cer (mCRPC), which is incurable and results in a median overall survival of 2-3 years.
Treatment options for patients with mCRPC include several systemic agents, such as andro-gen receptor-targeted agents (ARTA), chemotherapy (docetaxel, cabazitaxel) and bone-targeting agents (radium- 223). Clinical progression and, to a lesser extent, biochemical pro-gression traditionally imply a switch to the next line systemic treatment (NEST). Within patients with mCRPC, there is a subgroup showing oligo-progression, defined as the progression of up to 3 lesions, including both metastatic and/or local relapse. Oligoprogression reflects a heterogeneous treatment response, which, in turn, reflects the heterogeneity of the clonogenic cells that give rise to mCRPC. Retrospective studies suggest that metastasis-directed radiotherapy (MDRT) to these oligoprogressive lesions delayed the need for NEST. Recently, promising results were published on the use of MDRT in the oligopro-gressive mCRPC (omCRPC) setting, with a NEST-free survival (NEST-FS) of 21 months in well selected patients. Currently, in The Netherlands, patients with omCRPC are frequently referred and treated with MDRT, but a clear treatment protocol and inclusion/selection criteria are missing. Moreover, the exact benefit of MDRT in patients with omCRPC remains unclear, as prospective evi-dence for MDRT in omCRPC is lacking.
Read the detailed description
The primary aim of this study is to test the hypothesis that the addition of MDRT to standard of care (ADT or ADT + chemotherapy or ARTA) in well-selected PCa patients with oligometastatic progressive disease, defined on PSMA PET, prolongs the radiological progression-free survival (rPFS) and postpones the start of next line systemic therapy (NEST). Patients included in this study already have an indication to start NEST, and any delay introduced by adding MDRT will result in a net benefit for the patients.
Primary objectives include: Postponement of the start of next line systemic treatment (NEST), and enhancement of the radiological progression-free survival (rPFS) In this single arm multicenter prospective phase II trial, we aim to include 35 patients with omCRPC (1-3 metastases and/or local recurrence) who will be treated with MDRT to the visible progressive lesions (up to max of 3). Progression is based on PSMA PET.
- Conditions
- Prostate Cancer (Adenocarcinoma), OligoProgressive Metastatic Disease, Castration Resistant Metastatic Prostate Cancer, Radiotherapy
- Being tested
- Metastasis directed radiotherapy
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metastasis directed radiotherapyRadiation
According to guidelines, in the case of oligoprogression next line systemic treatment is recommended. This study investigates the potential delay of NEST and rPFS by MDRT.
| Study group | Role | What they receive |
|---|---|---|
| MDRT to oligoprogression | Experimental | Patients included in the study with a post prostatectomy local recurrence on the PSMA PET with up to 3 oligometastases will be treated preferably with SBRT to all oligometastatic lesions and to the local recurrence in prostate bed Receives: Radiation: Metastasis directed radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
NEST-FS
Next line systemic treatment free survival
Measured: 6, 12-and 24-months
rPFS
radiologic progression free survival
Measured: 6, 12-and 24-months
Secondary outcomes (12)
Quality of Life (QoL)
Evaluated using the EORTC QLQ-C30 for health related QoL.
Measured: baseline, 6 months, 12 months, 24 months
Biochemical progression
after an initial decline in PSA: the time from start of therapy to first PSA increase that is ≥25% and ≥ 2 ng/ml above the nadir, and which is confirmed by a second value ≥3 weeks later.
Measured: From date of randomization until the date of first documented biochmical progression, assessed up to 36 months
Overall survival (OS)
Overall survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Quality of life (QoL)
EORTC PR-25 for prostate symptom specific QoL.
Measured: baseline, 6 months, 12 months, 24 months
Acute grade ≥ 2 gastrointestinal toxicity
As assessed using physician-reported score: Common Terminology Criteria for adverse events version 5.0 (CTCAE-5) toxicity score with a scale of 1 - 4.
Measured: Up to 3 months after completion of the RT
Acute grade ≥ 2 gastrointestinal toxicity
Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4).
Measured: Up to 3 months after completion of the RT
Acute grade ≥ 2 genitourinary toxicities
As assessed using physician-reported score using questionnaires (CTCAE 5.0 toxicity score).
Measured: Up to 3 months after completion of the RT
Acute grade ≥ 2 genitourinary toxicities
Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4).
Measured: Up to 3 months after completion of the RT
Late grade ≥ 2 genitourinary toxicities
Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4).
Measured: Up to 2 years after completion of the RT
Late grade ≥ 2 genitourinary toxicity
Using physician-reported score (CTCAE 5.0 toxicity score).
Measured: Up to 2 years after completion of the RT
Late grade ≥ 2 gastrointestinal toxicity
As assessed using physician-reported score (CTCAE 5.0 toxicity score).
Measured: Up to 2 years after completion of the RT
Late grade ≥ 2 gastrointestinal toxicity
Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4).
Measured: Up to 2 years after completion of the RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start3 Jan 2025
- Primary completion3 Jan 2028 (estimated)
- Study completion3 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038304
- Sponsor's protocol ID
- NL87430.042.24
- Acronym
- OLYMPIAN
- Status last verified
- Jun 2025
- First submitted
- 4 Mar 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oligometastatic Directed Radiotherapy for Patients With Castration Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT07038304
- Acronym / sponsor ID
- OLYMPIAN / NL87430.042.24
- Conditions
- Prostate Cancer (Adenocarcinoma), OligoProgressive Metastatic Disease, Castration Resistant Metastatic Prostate Cancer, Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 3 Jan 2028 (estimated)
- Study completion
- 3 Jan 2029 (estimated)
- First posted
- 26 Jun 2025 (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.
In patients with metastatic prostate cancer (PCa) who receive androgen deprivation therapy (ADT), the sensitivity to castration will eventually disappear due to the selection of castration-refractory clones. This will lead to the stage of metastatic castration-refractory prostate can-cer (mCRPC), which is incurable and results in a median overall survival of 2-3 years.
Treatment options for patients with mCRPC include several systemic agents, such as andro-gen receptor-targeted agents (ARTA), chemotherapy (docetaxel, cabazitaxel) and bone-targeting agents (radium- 223). Clinical progression and, to a lesser extent, biochemical pro-gression traditionally imply a switch to the next line systemic treatment (NEST). Within patients with mCRPC, there is a subgroup showing oligo-progression, defined as the progression of up to 3 lesions, including both metastatic and/or local relapse. Oligoprogression reflects a heterogeneous treatment response, which, in turn, reflects the heterogeneity of the clonogenic cells that give rise to mCRPC. Retrospective studies suggest that metastasis-directed radiotherapy (MDRT) to these oligoprogressive lesions delayed the need for NEST. Recently, promising results were published on the use of MDRT in the oligopro-gressive mCRPC (omCRPC) setting, with a NEST-free survival (NEST-FS) of 21 months in well selected patients. Currently, in The Netherlands, patients with omCRPC are frequently referred and treated with MDRT, but a clear treatment protocol and inclusion/selection criteria are missing. Moreover, the exact benefit of MDRT in patients with omCRPC remains unclear, as prospective evi-dence for MDRT in omCRPC is lacking.
Detailed description
The primary aim of this study is to test the hypothesis that the addition of MDRT to standard of care (ADT or ADT + chemotherapy or ARTA) in well-selected PCa patients with oligometastatic progressive disease, defined on PSMA PET, prolongs the radiological progression-free survival (rPFS) and postpones the start of next line systemic therapy (NEST). Patients included in this study already have an indication to start NEST, and any delay introduced by adding MDRT will result in a net benefit for the patients.
Primary objectives include: Postponement of the start of next line systemic treatment (NEST), and enhancement of the radiological progression-free survival (rPFS) In this single arm multicenter prospective phase II trial, we aim to include 35 patients with omCRPC (1-3 metastases and/or local recurrence) who will be treated with MDRT to the visible progressive lesions (up to max of 3). Progression is based on PSMA PET.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDRT to oligoprogression | Experimental | Radiation: Metastasis directed radiotherapyPatients included in the study with a post prostatectomy local recurrence on the PSMA PET with up to 3 oligometastases will be treated preferably with SBRT to all oligometastatic lesions and to the local recurrence in prostate bed |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adenocarcinoma of the prostate.
- mCRPC setting, with testosterone level < 50 ng/dl or 1.7 nmol/l.
- Oligoprogressive disease diagnosed on PSMAscan; defined as the progression of pre-existing metastatic disease, and/or the appearance of new metastases and/or the appearance of a local relapse with a maximum of 3 lesions in total.
- Patients currently treated with ADT, whether combined with another systemic treatment such as ARTA, chemotherapy.
- For patients treated with chemotherapy, the course should be completed or stopped before start MORT - In case of treatment with ARTA, a minimal of 3 months response (PSA or clinical response).
Key exclusion criteria (7 listed)
- Serum testosterone level > 50 ng/ml or > 1.7 nmol/l.
- Presence of more than 3 progressive/new metastatic lesions and/or local recurrence (which counts for 1 lesion).
- Active malignancy other than prostate cancer that can potentially interfere with the interpretation of the trial, except non-melanoma skin cancer or non-invasive urothelial cell carcinoma.
- Local recurrence in the prostate after previous radiotherapy
- Previous treatments (RT, surgery) or comorbidities making new treatment with MDRT impossible.
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 |
|---|---|---|
| Metastasis directed radiotherapyAccording to guidelines, in the case of oligoprogression next line systemic treatment is recommended. This study investigates the potential delay of NEST and rPFS by MDRT. | Radiation | MDRT to oligoprogression |
Primary outcome
NEST-FS
Time frame: 6, 12-and 24-months
Next line systemic treatment free survival
rPFS
Time frame: 6, 12-and 24-months
radiologic progression free survival
12 secondary outcomes
Quality of Life (QoL)
Time frame: baseline, 6 months, 12 months, 24 months
Biochemical progression
Time frame: From date of randomization until the date of first documented biochmical progression, assessed up to 36 months
Overall survival (OS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Quality of life (QoL)
Time frame: baseline, 6 months, 12 months, 24 months
Acute grade ≥ 2 gastrointestinal toxicity
Time frame: Up to 3 months after completion of the RT
Acute grade ≥ 2 gastrointestinal toxicity
Time frame: Up to 3 months after completion of the RT
Acute grade ≥ 2 genitourinary toxicities
Time frame: Up to 3 months after completion of the RT
Acute grade ≥ 2 genitourinary toxicities
Time frame: Up to 3 months after completion of the RT
Late grade ≥ 2 genitourinary toxicities
Time frame: Up to 2 years after completion of the RT
Late grade ≥ 2 genitourinary toxicity
Time frame: Up to 2 years after completion of the RT
Late grade ≥ 2 gastrointestinal toxicity
Time frame: Up to 2 years after completion of the RT
Late grade ≥ 2 gastrointestinal toxicity
Time frame: Up to 2 years after completion of the RT
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 26 Jun 2025.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metastasis directed radiotherapy in people with Prostate Cancer (Adenocarcinoma) and OligoProgressive Metastatic Disease, run by University Medical Center Groningen at 2 sites in Netherlands.
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 9 inclusion and 7 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 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Shafak Aluwini (+31625649975, s.al-uwini@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NEST-FS (time frame: 6, 12-and 24-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.