Prostate CancerPhase 2NCT02972060
ODM-201 vs Androgen Deprivation Therapy in Hormone naïve Prostate Cancer
A Phase 2 study testing ODM-201 and ADT in people with Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 12 sites in 4 countries.
Trial summary
This is an open label non-comparative controlled randomized phase II study. The experimental arm is the group receiving ODM-201. The group receiving androgen-deprivation therapy (ADT) is included as an internal control. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ODM-201 and ADT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 1 Dec 2017to Dec 2036
- 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 prostate cancer (all stages) for whom continuous androgen-deprivation therapy (ADT) is indicated for a minimum period of 24 weeks
- Patient presenting with a maximum of 4 confirmed metastatic lesions, including bone, extra-pelvic lymph nodes, and pelvic lymph nodes > 2 cm on baseline Computed tomography(CT) or Magnetic resonance imaging (MRI) and/or Tc bone scintigraphy. Visceral metastases are excluded
- Asymptomatic for metastatic prostate cancer; urinary symptoms are allowed
- Baseline testosterone ≥ 8 nmol/L or 230 ng/dL
- Two subsequent PSA values ≥ 2 ng/ml, taken at minimum 2-week interval, with the second being equal to or higher than the first one
- WHO performance status (PS) of 0-1
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- G8 score ≥ 14 for patients aged ≥ 70 years old
- A life expectancy of at least 12 months
- Able to swallow the study drug and comply with the study requirements
- Adequate bone marrow function (absolute neutrophil count (ANC) ≥ 1.5 10exp9/L; hemoglobin ≥ 10.0 g/dl, platelets ≥ 100 10exp9/L)
- Adequate renal function: creatinine clearance/eGFR within normal limits to baseline assessed as per local standard method
- Albumin > 25 g/L
- Adequate hepatic function:
- Bilirubin: total bilirubin ≤ to 1.5 X upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and/or Alanine aminotransferase(ALT) ≤ 2.5 X ULN
- Normal cardiac function according to local standard by 12-lead Electrocardiogram (ECG) (complete, standardized 12-lead recording)
- Before patient registration/randomization, written informed consent must be given according to International Conference on Harmonization on Good Clinical Practices (ICH/GCP), and national/local regulations.
Who cannot join
- any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Previously or currently receiving hormonal therapy with intent to treat prostate cancer disease (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, anti-androgens, oestrogens, 5α-reductase inhibitor). For patients that have received (neo)adjuvant ADT before radiotherapy, it should have been stopped for more than 1 year
- Prior use of investigational agents that block androgen synthesis or block androgen receptor
- Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g. saw palmetto)
- Has received systemic glucocorticoids within 24 weeks prior to enrollment or is expected to require systemic glucocorticoids during the study period
- Radiation therapy for treatment of the primary tumor within 3 months prior to enrollment
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- Use of an investigational agent within 4 weeks prior to enrollment is not allowed. The maximum allowed duration may be extended to comply with national regulations in the participating countries.
- Gastrointestinal disorder affecting absorption (e.g. gastrectomy, active peptic ulcer disease within 3 months prior to enrollment)
- Known hypersensitivity to the study treatment or any of its ingredients (refer to Investigator's brochure).
- Severe or uncontrolled concurrent disease, infection or co-morbidity including active viral hepatitis, known human immunodeficiency virus infection with detectable viral load (Human immunodeficiency virus (HIV)) or chronic liver disease
- History of prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e. pTis, pTa, and pT1) is allowed, as well as any other cancer for which chemotherapy has been completed ≤ 5 years ago and from which the patient has been disease-free.
- Clinically significant cardiovascular disease including:
- Myocardial infarction within six months prior to randomization
- Uncontrolled angina within 3 months prior to randomization
- Coronary/peripheral artery bypass within 6 months prior to randomization
- Stroke within 6 months prior to randomization
- Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subjects with history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan (MUGA) performed within 3 months results in a left ventricular ejection fraction that is ≥ 45%
- History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes)
- 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 blood pressure >170 mm Hg or diastolic blood pressure > 105 mm Hg at the screening visit
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
Spain5 sites
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol
Badalona, 08916
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Universitario Virgen De La Victoria
Málaga, 29010
Hospital Universitario de Salamanca
Salamanca, 37007
Fundacion Instituto Valenciano De Oncologia
Valencia, 46009
Belgium4 sites
Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme
Brussels, 1070
Cliniques Universitaires Saint-Luc
Brussels, 1200
Universitair Ziekenhuis Gent
Ghent, 9000
CHU Dinant Godinne - UCL Namur
Yvoir, 5530
France2 sites
CHU de Dijon - Centre Georges-Francois-Leclerc
Dijon, 21079
Gustave Roussy
Villejuif, 94805
Italy1 site
Azienda Ospedaliera Citta della Salute e della Scienza di Torino - Ospedale Molinette
Torino, 10126
About this study
Official title: A Phase 2 Randomized Open-Label Study of Oral Darolutamide (ODM-201) vs. Androgen Deprivation Therapy (ADT) With LHRH Agonists or Antagonist in Men With Hormone Naive Prostate Cancer
This is an open label non-comparative controlled randomized phase II study. The experimental arm is the group receiving ODM-201. The group receiving androgen-deprivation therapy (ADT) is included as an internal control.
The primary trial objective is to demonstrate that ODM-201 produces prostate-specific antigen (PSA) response rates at 24 weeks (defined as ≥80% reduction compared to baseline) that are in the range of those achieved with 24 weeks of ADT.
In total, this 1:1 randomized study will therefore require randomization of at least 250 patients, 125 to each arm.
Read the detailed description
ODM 201 will be administered as oral 300-mg tablets. The dose of study drug to be administered is 600 milligrams (mg) (2 x 300-mg tablets) twice daily (bid) for a daily dose of 1200 mg. It is recommended that ODM-201 be taken with food.
Subjects who have clinical benefit at week 24 may continue to receive ODM-201 at the discretion of the investigator until disease progression, objective or clinical, or occurrence of an unacceptable toxicity. This includes those that will receive external beam radiation therapy.
Any anti-cancer therapy other than the study drug given as single agent will not be considered part of the protocol treatment.
The standard treatment for this stage of the disease is androgen deprivation therapy (ADT) by means of Luteinizing hormone-releasing hormone (LHRH) antagonist for 24 weeks or by LHRH agonist therapy for 24 weeks with 4 weeks of anti-androgen to prevent flare.
This includes leuprolide, goserelin, triptorelin, and degarelix. Beyond week 24, the treatment will be left to the discretion of the treating physician.
The primary trial objective is to demonstrate that ODM-201 produces prostate-specific antigen (PSA) response rates at 24 weeks (defined as ≥80% reduction compared to baseline) that are in the range of those achieved with 24 weeks of ADT.
The secondary objectives are to:
- To document the effects of ODM-201 compared to ADT in terms of patient-reported side effects of hormonal therapy, based on the Hormonal treatment (HTR) symptom scale of EORTC QLQ PR25 at 24 weeks;
- To document the effects of ODM-201 compared to ADT in terms of patient-reported side effects of hormonal therapy, based on EORTC QLQ C30 and PR25 at 24 weeks;
- To document the effect of ODM-201 on PSA complete response at 24 weeks (defined as ≥ 90% reduction from baseline);
- To document the effect of ODM-201 on objective response rate at 24 weeks in patients with RECIST 1.1 measurable disease at baseline;
- To document the safety and tolerability of ODM-201 vs. ADT in subjects who have not previously received hormone treatment for prostate cancer;
- To document the effects of ODM-201 on androgen deprivations symptoms using the Aging male symptoms (AMS) questionnaires;
- To document the proportion of patients who opted to continue treatment with ODM-201 beyond the protocolized 24 weeks
The primary endpoint is the PSA response assessed at 24 weeks. PSA response is defined as a ≥ 80% decline in PSA measurement taken at week 24 relative to the measurement taken at baseline, in the ODM-201 study arm. The ADT arm is used as an internal control.
Key secondary endpoints:
- Change in hormone-treatment related symptoms scale of the EORTC QLQ-PR25 at 24 weeks compared to baseline in the ODM-201 study arm. A 10-point difference is regarded as a clinically meaningful benefit.
- Objective response rate at 24 weeks in patients with RECIST 1.1 measurable disease at baseline
- PSA response at 24 weeks defined as a ≥90% decline in PSA compared to baseline
- Safety according to National Cancer Institute - Common terminology for adverse events (NCI-CTC) version 4.0
- Conditions
- Prostate Cancer
- Being tested
- ODM-201, ADT
- Keywords
- Hormone Naive Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ODM-201Drug
ODM-201 is a novel, oral, potent nonsteroidal AR inhibitor. ODM 201 will be administered as oral 300-mg tablets. The dose of study drug to be administered is 600 mg (2 x 300-mg tablets) b.i.d. to a daily dose of 1200 mg. It is recommended that ODM-201 be taken with food. Treatment should be initiated within 28 days from randomization.
ADTDrug
ADT by means of LHRH antagonist for 24 weeks or by LHRH agonist therapy for 24 weeks with 4 weeks of anti-androgen to prevent flare.
This includes leuprolide, goserelin, triptorelin, and degarelix. Beyond week 24, the treatment will be left to the discretion of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| ADT | Active comparator | The standard treatment for this stage of the disease is ADT by means of LHRH antagonist for 24 weeks or by LHRH agonist therapy for 24 weeks with 4 weeks of anti-androgen to prevent flare.
This includes leuprolide, goserelin, triptorelin, and degarelix. Beyond week 24, the treatment will be left to the discretion of the treating physician. Receives: Drug: ADT |
| ODM 201 | Experimental | ODM 201 will be administered as oral 300-mg tablets. The dose of study drug to be administered is 600 mg (2 x 300-mg tablets) bid for a daily dose of 1200 mg. It is recommended that ODM-201 be taken with food.
Subjects who have clinical benefit at week 24 may continue to receive ODM-201 at the discretion of the investigator until disease progression, objective or clinical, or occurrence of an unacceptable toxicity. This includes those that will receive external beam radiation therapy.
Any anti-cancer therapy other than the study drug given as single agent will not be considered part of the protocol treatment. Receives: Drug: ODM-201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA response
PSA response is defined as a ≥ 80% decline in PSA measurement taken at week 24 relative to the measurement taken at baseline, in the ODM-201 study arm. The ADT arm is used as an internal control.
Measured: 24 weeks
Secondary outcomes (4)
EORTC QLQ-PR25
Change in hormone-treatment related symptoms scale of the EORTC QLQ-PR25 at 24 weeks compared to baseline in the ODM-201 study arm. A 10-point difference is regarded as a clinically meaningful benefit.
Measured: 24 weeks
Objective tumor response
Objective response rate at 24 weeks in patients with RECIST 1.1 measurable disease at baseline
Measured: 24 weeks
90% PSA response rate
PSA response at 24 weeks defined as a ≥90% decline in PSA compared to baseline
Measured: 24 weeks
evaluation of safety
All adverse events will be recorded; the investigator will assess whether those events are drug related (reasonable possibility, no reasonable possibility) and this assessment will be recorded in the database for all adverse events.
Measured: The collection period will start from randomization until 30 days after last protocol treatment administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study start1 Dec 2017
- Primary completion13 Jan 2023
- Study completionDec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Bertrand Tombal, Pr, Study chair, Cliniques universitaires saint-Luc (Brussels)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972060
- Sponsor's protocol ID
- EORTC-1532
- Other IDs
- 2016-004334-17, 2016
- Status last verified
- Sep 2025
- First submitted
- 21 Nov 2016
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized Open-Label Study of Oral Darolutamide (ODM-201) vs. Androgen Deprivation Therapy (ADT) With LHRH Agonists or Antagonist in Men With Hormone Naive Prostate Cancer
- ClinicalTrials.gov ID
- NCT02972060
- Acronym / sponsor ID
- EORTC-1532
- Conditions
- Prostate Cancer
- Keywords
- Hormone Naive Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 61 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Collaborators
- Bayer
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- Dec 2036 (estimated)
- First posted
- 23 Nov 2016 (estimated)
- 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.
This is an open label non-comparative controlled randomized phase II study. The experimental arm is the group receiving ODM-201. The group receiving androgen-deprivation therapy (ADT) is included as an internal control.
The primary trial objective is to demonstrate that ODM-201 produces prostate-specific antigen (PSA) response rates at 24 weeks (defined as ≥80% reduction compared to baseline) that are in the range of those achieved with 24 weeks of ADT.
In total, this 1:1 randomized study will therefore require randomization of at least 250 patients, 125 to each arm.
Detailed description
ODM 201 will be administered as oral 300-mg tablets. The dose of study drug to be administered is 600 milligrams (mg) (2 x 300-mg tablets) twice daily (bid) for a daily dose of 1200 mg. It is recommended that ODM-201 be taken with food.
Subjects who have clinical benefit at week 24 may continue to receive ODM-201 at the discretion of the investigator until disease progression, objective or clinical, or occurrence of an unacceptable toxicity. This includes those that will receive external beam radiation therapy.
Any anti-cancer therapy other than the study drug given as single agent will not be considered part of the protocol treatment.
The standard treatment for this stage of the disease is androgen deprivation therapy (ADT) by means of Luteinizing hormone-releasing hormone (LHRH) antagonist for 24 weeks or by LHRH agonist therapy for 24 weeks with 4 weeks of anti-androgen to prevent flare.
This includes leuprolide, goserelin, triptorelin, and degarelix. Beyond week 24, the treatment will be left to the discretion of the treating physician.
The primary trial objective is to demonstrate that ODM-201 produces prostate-specific antigen (PSA) response rates at 24 weeks (defined as ≥80% reduction compared to baseline) that are in the range of those achieved with 24 weeks of ADT.
The secondary objectives are to:
- To document the effects of ODM-201 compared to ADT in terms of patient-reported side effects of hormonal therapy, based on the Hormonal treatment (HTR) symptom scale of EORTC QLQ PR25 at 24 weeks;
- To document the effects of ODM-201 compared to ADT in terms of patient-reported side effects of hormonal therapy, based on EORTC QLQ C30 and PR25 at 24 weeks;
- To document the effect of ODM-201 on PSA complete response at 24 weeks (defined as ≥ 90% reduction from baseline);
- To document the effect of ODM-201 on objective response rate at 24 weeks in patients with RECIST 1.1 measurable disease at baseline;
- To document the safety and tolerability of ODM-201 vs. ADT in subjects who have not previously received hormone treatment for prostate cancer;
- To document the effects of ODM-201 on androgen deprivations symptoms using the Aging male symptoms (AMS) questionnaires;
- To document the proportion of patients who opted to continue treatment with ODM-201 beyond the protocolized 24 weeks
The primary endpoint is the PSA response assessed at 24 weeks. PSA response is defined as a ≥ 80% decline in PSA measurement taken at week 24 relative to the measurement taken at baseline, in the ODM-201 study arm. The ADT arm is used as an internal control.
Key secondary endpoints:
- Change in hormone-treatment related symptoms scale of the EORTC QLQ-PR25 at 24 weeks compared to baseline in the ODM-201 study arm. A 10-point difference is regarded as a clinically meaningful benefit.
- Objective response rate at 24 weeks in patients with RECIST 1.1 measurable disease at baseline
- PSA response at 24 weeks defined as a ≥90% decline in PSA compared to baseline
- Safety according to National Cancer Institute - Common terminology for adverse events (NCI-CTC) version 4.0
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADT | Active comparator | Drug: ADTThe standard treatment for this stage of the disease is ADT by means of LHRH antagonist for 24 weeks or by LHRH agonist therapy for 24 weeks with 4 weeks of anti-androgen to prevent flare. This includes leuprolide, goserelin, triptorelin, and degarelix. Beyond week 24, the treatment will be left to the discretion of the treating physician. |
| ODM 201 | Experimental | Drug: ODM-201ODM 201 will be administered as oral 300-mg tablets. The dose of study drug to be administered is 600 mg (2 x 300-mg tablets) bid for a daily dose of 1200 mg. It is recommended that ODM-201 be taken with food. Subjects who have clinical benefit at week 24 may continue to receive ODM-201 at the discretion of the investigator until disease progression, objective or clinical, or occurrence of an unacceptable toxicity. This includes those that will receive external beam radiation therapy. Any anti-cancer therapy other than the study drug given as single agent will not be considered part of the protocol treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically confirmed prostate cancer (all stages) for whom continuous androgen-deprivation therapy (ADT) is indicated for a minimum period of 24 weeks
- Patient presenting with a maximum of 4 confirmed metastatic lesions, including bone, extra-pelvic lymph nodes, and pelvic lymph nodes > 2 cm on baseline Computed tomography(CT) or Magnetic resonance imaging (MRI) and/or Tc bone scintigraphy. Visceral metastases are excluded
- Asymptomatic for metastatic prostate cancer; urinary symptoms are allowed
- Baseline testosterone ≥ 8 nmol/L or 230 ng/dL
- Two subsequent PSA values ≥ 2 ng/ml, taken at minimum 2-week interval, with the second being equal to or higher than the first one
Key exclusion criteria (20 listed)
- any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Previously or currently receiving hormonal therapy with intent to treat prostate cancer disease (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, anti-androgens, oestrogens, 5α-reductase inhibitor). For patients that have received (neo)adjuvant ADT before radiotherapy, it should have been stopped for more than 1 year
- Prior use of investigational agents that block androgen synthesis or block androgen receptor
- Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g. saw palmetto)
- Has received systemic glucocorticoids within 24 weeks prior to enrollment or is expected to require systemic glucocorticoids during the study period
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 |
|---|---|---|
| ODM-201ODM-201 is a novel, oral, potent nonsteroidal AR inhibitor. ODM 201 will be administered as oral 300-mg tablets. The dose of study drug to be administered is 600 mg (2 x 300-mg tablets) b.i.d. to a daily dose of 1200 mg. It is recommended that ODM-201 be taken with food. Treatment should be initiated within 28 days from randomization. | Drug | ODM 201 |
| ADTADT by means of LHRH antagonist for 24 weeks or by LHRH agonist therapy for 24 weeks with 4 weeks of anti-androgen to prevent flare. This includes leuprolide, goserelin, triptorelin, and degarelix. Beyond week 24, the treatment will be left to the discretion of the treating physician. | Drug | ADT |
Primary outcome
PSA response
Time frame: 24 weeks
PSA response is defined as a ≥ 80% decline in PSA measurement taken at week 24 relative to the measurement taken at baseline, in the ODM-201 study arm. The ADT arm is used as an internal control.
4 secondary outcomes
EORTC QLQ-PR25
Time frame: 24 weeks
Objective tumor response
Time frame: 24 weeks
90% PSA response rate
Time frame: 24 weeks
evaluation of safety
Time frame: The collection period will start from randomization until 30 days after last protocol treatment administration.
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 19 Sep 2025.
- 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. This study is not recruiting at the moment.
Bertrand Tombal, Pr study chair
Cliniques universitaires saint-Luc (Brussels)
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ODM-201 and ADT in people with Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 12 sites in 4 countries.
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 20 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 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain, Belgium, France, Italy. 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?
PSA response (time frame: 24 weeks). 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 19 Sep 2025.