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Metastatic Prostate CancerPhase 2NCT04070209

Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X)

A Phase 2 study testing Darolutamide (BAY1841788) and SBRT in people with Metastatic Prostate Cancer and Castration-resistant Prostate Cancer, run by Sir Mortimer B. Davis - Jewish General Hospital at 11 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is the first pilot phase II trial assessing the response of SBRT layered on Darolutamide (BAY1841788) on RPFS and deferring palliative second line systemic therapy in M0CRPC with oligoprogression. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Darolutamide (BAY1841788) and SBRT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
11 sitesCanada
Study dates
19 Oct 2020to Nov 2030
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

  • Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features;
  • M0CRPC at study entry defined as follows:
  • Ongoing androgen deprivation therapy with a LHRH agonist or bilateral orchiectomy (i.e., surgical or medical castration);
  • Serum testosterone level ≤ 1.7 nmol/L (50 ng/dL) at the Screening visit;
  • PSA progression defined by a minimum of two subsequent rising PSA levels with an interval of ≥ 1 week between each determination. Patients who received an anti-androgen must have progression after withdrawal (≥ 4 weeks since last flutamide or ≥ 6 weeks since last bicalutamide or nilutamide). The PSA value at the Screening visit should be ≥ 2 μg/L (2 ng/mL)
  • PSA doubling time of 10 months or less,
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  • M0 assessed by conventional imaging (CT/MRI + bone scan).
  • NOTE: If darolutamide started prior to study entry, evidence of inclusion criteria 1-5 listed above prior to start of darolutamide must be submitted to determine study eligibility
  • Prior cytotoxic chemotherapy for prostate cancer in adjuvant setting post radical therapy is allowed;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 or Karnofsky performance status of > 80% or higher;
  • Estimated life expectancy of ≥ 6 months;
  • Ability to swallow the study drug whole and comply with study.
  • Patients should not have been previously exposed to other ARATs (Abiraterone, Enzalutamide, Apalutamide)
  • ≤ 5 metastatic sites (on conventional imaging);
  • ≤ 4 tumors within any given organ system, excluding brain (e.g. up to 4 bone metastases, or 4 lung metastases);
  • All sites of disease must be amenable to SBRT with no history of the metastases being irradiated (radiation exposure prior to the development of the metastases is permitted as long as the radiation exposure was not intended for the metastases. For example, if there is prior pelvic radiation to the prostate and a subsequent iliac metastasis develops within the previously irradiated pelvic radiation field, then the iliac metastasis would be eligible per the institution policy and practice);
  • In the case of a suspicious lesion in an unusual location such as lung or thoracic lymph nodes (without other abdominal lymph nodes), a confirmatory imaging or biopsy is strongly recommended;

Who cannot join

  • Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment;
  • Presence of distant metastasis, including previously treated (clinical stage M1) is exclusive, however isolated pelvic nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion criteria.
  • History of another malignancy within the previous 5 years other than curatively treated non-melanoma skin cancer;
  • Absolute neutrophil count < 1,500/μL, platelet count < 100,000/μL, or hemoglobin < 5.6 mmol/L (9 g/dL) at the Screening visit (NOTE: patients may not have received any growth factors within 7 days or blood transfusions within 28 days of the hematologic laboratory values obtained at the Screening visit);
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal and total bilirubin > 1.5 times the upper limit of normal at the Screening visit;
  • Creatinine > 2 times the upper limit of normal at the Screening visit;
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  • Clinically significant cardiovascular disease including:
  • Stroke or myocardial infarction within 6 months;
  • Uncontrolled angina within 6 months;
  • Coronary/peripheral artery bypass graft within 6 months;
  • Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or patients with history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan performed within three months results in a left ventricular ejection fraction that is ≥ 45%;
  • History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place;
  • Uncontrolled hypertension as indicated by a resting systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg at screening. Patients may be re-screened after adjustments of antihypertensive medications;
  • Bradycardia as indicated by a heart rate of < 50 beats per minute on the Screening ECG;
  • Gastrointestinal disorder or procedure which expects to interfere significantly with absorption (e.g., gastrectomy, active peptic ulcer disease within last 3 months);
  • Major surgery within 4 weeks of enrollment (Day 1 Visit);
  • Active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease
  • Use of opiate analgesics (eg. morphine, fentanyl, etc.) for pain from prostate cancer within 4 weeks of enrollment (Day 1 visit). This does not apply to non-morphine drugs like codeine;
  • Radiation therapy for treatment of the primary tumor within 3 weeks of enrollment (Day 1 visit);
  • Radiation or radionuclide therapy for treatment of metastasis;
  • Primary disease not treated;
  • Hormone naïve prostate cancer patients;
  • Treatment with estrogens or AR inhibitors (bicalutamide, flutamide, nilutamide, cyproterone acetate) within 4 weeks of enrollment (Day 1 visit);
  • Treatment with systemic biologic therapy for prostate cancer (other than approved bone targeted agents and GnRH-analogue therapy) or other agents with anti-tumour activity within 4 weeks of enrollment (Day 1 visit);
  • Prior use of an investigational agent that blocks androgen synthesis (e.g., abiraterone acetate, enzalutamide, Apalutamide, TAK-700, TAK-683, TAK-448) or targets the androgen receptor (e.g., BMS 641988) on clinical trials;
  • Known or suspected contraindications or hypersensitivity to darolutamide or GnRH agonists or any of the components of the formulations;
  • Use of an investigational agent within 4 weeks of enrollment (Day 1 visit);
  • Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids greater than the equivalent of 10 mg of prednisone per day within four weeks of enrollment (Day 1 visit);
  • Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data;
  • Unable to swallow study medications and comply with study requirements
  • Known or suspected brain metastasis or active leptomeningeal disease;
  • > 5 metastasis;
  • More than 4 metastasis in the same organ;
  • Patients considered for SBRT in previous history of radiation therapy to the same area.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Canada11 sites

  • Prostate Cancer Centre

    Calgary, Alberta, T2V 1P9

  • Hôpital de Gatineau

    Gatineau, Quebec, J8P 7H2

  • Centre of Applied Urology Research

    Halifax, Nova Scotia, B3H 2Y9

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

  • Service d'urologie et Centre de la prostate

    Longueuil, Quebec, J4V 2H3

  • Hôpital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • Centre hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec, H2X 3E4

  • Sir Mortimer JGH

    Montreal, Quebec, H3T 1E2

  • L'Hôtel-Dieu de Québec (CHUQ)

    Québec, Quebec, G1R 2J6

  • Hôpital Fleurimont (CHUS)

    Sherbrooke, Quebec, J1H 5N4

  • Centre hospitalier affilié universitaire régional (CHAUR)

    Trois-Rivières, Quebec, G8Z 3R9

Other trials in Canada

About this study

Official title: The Role of Therapeutic Layering of Stereotactic Body Radiotherapy on Darolutamide in the Management of Oligoprogressive Castration Resistant Prostate Cancer: A Pilot Phase II Trial

This is the first pilot phase II trial assessing the response of SBRT layered on Darolutamide (BAY1841788) on RPFS and deferring palliative second line systemic therapy in M0CRPC with oligoprogression.

Read the detailed description

Metastases-directed therapy with stereotactic body radiation therapy (SBRT) is emerging as a new treatment option for solid tumor patients with a limited number of metastases (< 5) at the time of recurrence/progression, so called oligoprogression therapy. As such, oligoprogression is defined as prostate cancer patients with castration resistance and no metastases (M0CRPC) who are receiving ADT and new generation hormonal therapy (enzalutamide, apalutamide or darolutamide) as standard of care, and who are then progressing to oligometastases. The new generation hormonal therapy used in this study will be darolutamide (ODM-201). The rationale behind this approach has been to delay the start of palliative systemic therapies that are most often toxic and associated with a negative impact on patient's quality of life, as well as being more costly. However, to date, there are no prospective published data or ongoing studies that are looking into non metastatic castration resistant prostate cancer (M0CRPC) patients who progress to oligometastases (oligoprogression). To this end, we are proposing this pilot phase II trial to assess the impact of SBRT on radiological progression-free survival (RPFS) of M0CRPC patients who are receiving darolutamide and progress to oligometastatic disease (oligoprogression).

Prostate cancer patients with castration resistance and no metastases (M0CRPC) diagnosed by bone scan and CT scan or MRI will be recruited in this phase II and initiate darolutamide while continuing on ADT (Part 1 of the study), if not receiving darolutamide prior to study entry already. Patients who then progress to wide spread metastases or metastases situated at locations not amenable to ablative therapy will be excluded and treated with second line therapy as per the treating physician. Patients with oligoprogression (< 5 mets) and amenable to ablative therapy will be then treated with SBRT or surgery as an ablative therapy if SBRT is not feasible (Part 2 of the study). All patients will continue to receive non-interrupted LHRH agonist, PSA testing every 6-12 weeks and re-imaging every 6 months. Imaging will also be repeated at the appearance of symptoms or at PSA progression, whichever occurs first and this schedule continues until disease progression.

This is the first pilot phase II trial assessing the response of SBRT layered on darolutamide on RPFS and deferring palliative second line systemic therapy in M0CRPC with oligoprogression. This phase II will consist of 66 M0CRPC patients treated with darolutamide, of which we anticipate 48 will be eligible for SBRT.

Being tested
Darolutamide (BAY1841788), SBRT
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Darolutamide (BAY1841788)Drug

    Also called ODM-201

    Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg.

  • SBRTRadiation

    SBRT will consist of 2-5 fractions of highly targeted radiation therapy delivered every other day. The radiation component will be completed in 4-10 days.

Study groups in NCT04070209
Study groupRoleWhat they receive
Darolutamide (BAY1841788)+ SBRTExperimentalCRPC subjects will receive LHRH agonist in combination with the new generation of hormonal therapy Darolutamide (300mg). Subjects who progress on LHRH + Darolutamide and develop oligometastases will receive SBRT
Receives: Drug: Darolutamide (BAY1841788); Radiation: SBRT

What is being measured

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

  1. Radiographic Progression-free Survival

    Time from first day of SBRT until confirmed second radiological progression or start of new antineoplastic therapy

    Measured: 5 years

Secondary outcomes (10)

  1. Functional Assessment of Cancer Therapy-Prostate

    Evaluate the impact of the treatment on the patient's quality of life using the FACT-P questionnaire

    Measured: 5 years

  2. Quality of Life - Fatigue

    Evaluate the impact of the treatment on the patient's quality of life using the Brief Fatigue Inventory (BFI) questionnaire

    Measured: 5 years

  3. Quality of Life - Pain

    Evaluate the impact of the treatment on the patient's quality of life using the Brief Pain Inventory (BPI) questionnaire

    Measured: 5 years

  4. Toxicity of ODM-201

    To determine acute and late toxicity due to ODM-201, scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    Measured: 5 years

  5. Time to Subsequent Systemic Antineoplastic Therapy

    Time to the administration of subsequent antineoplastic systemic therapy

    Measured: 5 years

  6. PSA response

    PSA value and onset of biochemical failure will be recorded

    Measured: 5 years

  7. Overall Survival

    Time from randomization until death from any cause

    Measured: 5 years

  8. Disease Specific Survival

    Time from randomization until death due to prostate cancer

    Measured: 5 years

  9. Time to Skeletal-related Event (SRE)

    Date of first SRE will be recorded

    Measured: 5 years

  10. Local Control

    To evaluate the impact of SBRT on oligometastases progression by radiographic imaging or the start of new antineoplastic therapy.

    Measured: 5 years

Timeline

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

  1. First posted28 Aug 2019
  2. Study start19 Oct 2020
  3. Primary completionNov 2030 (estimated)
  4. Study completionNov 2030 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04070209
Sponsor's protocol ID
PCS X
Status last verified
Apr 2026
First submitted
24 Aug 2019
Last updated
27 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Darolutamide (BAY1841788) and SBRT in people with Metastatic Prostate Cancer and Castration-resistant Prostate Cancer, run by Sir Mortimer B. Davis - Jewish General Hospital at 11 sites in Canada.

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 17 inclusion and 34 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: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Canada. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Progression-free Survival (time frame: 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 NCT04070209.

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 27 May 2026.

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