Prostate CancerPhase 2NCT07282197
Darolutamide+ADT Post-RP w/o ePLND in hrPC: Briganti 2019
A Phase 2 study testing Darolutamide (BAY 1841788) in people with Prostate Cancer, run by Peking University First Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate whether adjuvant darolutamide plus androgen-deprivation therapy (ADT) can reduce post-operative recurrence and improve disease control in high-risk prostate cancer patients-defined by the Briganti 2019 nomogram-who have undergone radical prostatectomy (RP) without… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Darolutamide (BAY 1841788)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jan 2026to Jun 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient volunteers to participate and signs the informed consent form (ICF);
- Age 18-75 years (inclusive), male;
- Histologically or cytologically confirmed prostatic adenocarcinoma;
- No non-regional lymph-node metastasis, bone metastasis, or other distant metastasis (e.g., visceral) by conventional imaging (bone scan, CT or MRI) or by PET/CT; i.e., M0;
- High-risk per the Briganti 2019 nomogram, i.e., risk >7%;
- PSA <0.1 ng/mL at 6 weeks after radical prostatectomy (RP);
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- Has undergone RP without pelvic lymph-node dissection;
- Not suitable for adjuvant/salvage radiotherapy (RT) after RP, or the patient declines RT;
- Patients with lymph-node involvement (LNI) indicated by PSMA-PET who did not undergo extended pelvic lymph-node dissection (ePLND) may be enrolled;
- Patients with negative intraoperative obturator lymph-node biopsy who did not undergo ePLND may be enrolled;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
- Adequate hematologic and organ function:
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L (1500/µL);
- Hemoglobin ≥90 g/L (9.0 g/dL);
- Platelet count ≥100 × 10⁹/L (100,000/µL) (without transfusion and/or growth factors within 3 months prior to starting study treatment);
- Serum potassium ≥3.5 mmol/L;
- Total bilirubin (TBIL) ≤2.0 × ULN (for Gilbert syndrome, TBIL >1.5 × ULN is not eligible; if indirect bilirubin ≤1.5 × ULN, enrollment is allowed);
- AST and ALT ≤2.5 × ULN;
- Serum albumin ≥30 g/L (3.0 g/dL);
- Serum creatinine <2 × ULN;
- Patients of childbearing potential must agree to use effective contraception throughout the study and for 3 months after the last dose.
Who cannot join
- Histologic features of neuroendocrine differentiation or small-cell carcinoma;
- Prior prostate cancer treatments including any of the following:
- Systemic therapy, including but not limited to: >2 months of ADT; >2 months of conventional hormonal therapy (e.g., flutamide, bicalutamide); next-generation hormonal agents (e.g., darolutamide, abiraterone, apalutamide, enzalutamide, relugolix); chemotherapy (e.g., docetaxel); immunotherapy; targeted therapy;
- Local radiotherapy;
- Planned bilateral orchiectomy during the study treatment period;
- Inability to tolerate darolutamide or ADT;
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- Concurrent participation in, or planned participation in, another clinical trial;
- A malignancy other than prostate cancer within the past 5 years or concurrently, except for cured basal cell carcinoma of the skin;
- Any concomitant disease or condition that, in the investigator's judgment, presents a serious risk to patient safety, may confound study results, or may interfere with completion of the study (e.g., severe cardiovascular disease, active infection, gastrointestinal disease, neurologic or psychiatric disorders, etc.);
- Any other condition deemed by the investigator to make the patient unsuitable for this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University First Hospital
Beijing
Jianhui Qiu, (86)-010-83572075, 16710080711@139.com
About this study
Official title: Efficacy and Safety Evaluation of Darolutamide+ADT Adjuvant After Radical Prostatectomy (RP) Without ePLND, in High-risk Prostate Cancer Patients Based on Briganti 2019 Nomogram: A Phase II, Single-center, Single-arm, Prospective Study
The goal of this clinical trial is to evaluate whether adjuvant darolutamide plus androgen-deprivation therapy (ADT) can reduce post-operative recurrence and improve disease control in high-risk prostate cancer patients-defined by the Briganti 2019 nomogram-who have undergone radical prostatectomy (RP) without extended pelvic lymph node dissection (ePLND). The main questions it aims to answer are:
- What proportion of participants remains biochemical-recurrence-free at 2 years, using NCCN criteria (PSA increase >0.1 ng/mL above post-treatment nadir confirmed by two tests ≥2 weeks apart)?
- What proportion of participants is the 2-year radiographic progression-free survival (rPFS)?
Read more
Additional key outcomes include:
- PSA undetectable rates at 6, 12, and 24 months (PSA <0.01 ng/mL).
- Safety and tolerability assessed by CTCAE v5.0.
- Exploratory** patient-reported outcomes: urinary symptoms (IPSS) and quality of life (EQ-5D-3L).
Study type \& design: Phase II, single-center, single-arm, prospective interventional study. Enrollment occurs within 12 weeks after RP. ADT is delivered with a GnRH agonist (physician's choice); orchiectomy is excluded. Target sample size is approximately 40 participants; the statistical plan uses a one-sample log-rank framework. Primary and secondary endpoints are assessed over 2 years.
Participants will: Provide informed consent and undergo eligibility confirmation (high-risk per Briganti 2019; post-RP without ePLND; enrollment ≤12 weeks after surgery). Receive darolutamide + ADT according to protocol (GnRH agonist; no orchiectomy). Attend scheduled visits for PSA monitoring, safety labs, and adverse-event assessments (CTCAE v5.0). Undergo radiologic evaluations as per protocol to determine rPFS (RECIST 1.1/PCWG3). Complete IPSS and EQ-5D-3L questionnaires at specified time points to assess urinary symptoms and quality of life.
Primary endpoint: 2-year biochemical-recurrence-free rate. Key secondary endpoints: 2-year rPFS; PSA <0.01 ng/mL at 6/12/24 months; treatment-emergent adverse events.
Exploratory endpoints: IPSS and EQ-5D-3L changes over 2 years.
This trial aims to balance oncologic control with quality of life in a population for whom the therapeutic value of ePLND remains uncertain, by testing whether early adjuvant darolutamide + ADT after RP can meaningfully delay recurrence and progression while maintaining acceptable tolerability.
- Conditions
- Prostate Cancer
- Being tested
- Darolutamide (BAY 1841788)
- 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 (BAY 1841788)Drug
Darolutamide 600 mg bid + ADT x 12 months
| Study group | Role | What they receive |
|---|---|---|
| Daro+ADT | Experimental | High-risk prostate cancer patients (Briganti 2019 monogram criteria) who did not undergo extended pelvic lymph node dissection (ePLND), will receive Darolutamide 600 mg bid + ADT for 12 months within 12 weeks after RP. Receives: Drug: Darolutamide (BAY 1841788) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who remained biochemical recurrence free for 2 years
biochemical recurrence defined as a PSA increase >0.1 ng/ml above the post-treatment nadir (confirmed by two consecutive measures at least 2 weeks apart), according to NCCN criteria
Measured: 2 years
Secondary outcomes (3)
2-year rate of radiological progression-free survival (rPFS)
rPFS define as the first date of darolutamide+ ADT to the date of first documented radiological progression per RECIST 1.1 for soft tissue or per Prostate Cancer Working Group 3 (PCWG3) for bone lesions, the development of symptoms or complications attributable to cancer progression
Measured: 2 years
6-month/ 12-month/ 24-month PSA undetectable rate
defined as the rate of patients with PSA <0.01 ng/mL
Measured: 2 years
TEAEs
Measured by the number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionJun 2029 (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 Peking University First HospitalThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kan Gong, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282197
- Sponsor's protocol ID
- 23096
- Status last verified
- Oct 2025
- First submitted
- 2 Dec 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Darolutamide+ADT Adjuvant After Radical Prostatectomy (RP) Without ePLND, in High-risk Prostate Cancer Patients Based on Briganti 2019 Nomogram: A Phase II, Single-center, Single-arm, Prospective Study
- ClinicalTrials.gov ID
- NCT07282197
- Acronym / sponsor ID
- 23096
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 15 Dec 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.
The goal of this clinical trial is to evaluate whether adjuvant darolutamide plus androgen-deprivation therapy (ADT) can reduce post-operative recurrence and improve disease control in high-risk prostate cancer patients-defined by the Briganti 2019 nomogram-who have undergone radical prostatectomy (RP) without extended pelvic lymph node dissection (ePLND). The main questions it aims to answer are:
- What proportion of participants remains biochemical-recurrence-free at 2 years, using NCCN criteria (PSA increase >0.1 ng/mL above post-treatment nadir confirmed by two tests ≥2 weeks apart)?
- What proportion of participants is the 2-year radiographic progression-free survival (rPFS)?
Additional key outcomes include:
- PSA undetectable rates at 6, 12, and 24 months (PSA <0.01 ng/mL).
- Safety and tolerability assessed by CTCAE v5.0.
- Exploratory** patient-reported outcomes: urinary symptoms (IPSS) and quality of life (EQ-5D-3L).
Study type \& design: Phase II, single-center, single-arm, prospective interventional study. Enrollment occurs within 12 weeks after RP. ADT is delivered with a GnRH agonist (physician's choice); orchiectomy is excluded. Target sample size is approximately 40 participants; the statistical plan uses a one-sample log-rank framework. Primary and secondary endpoints are assessed over 2 years.
Participants will: Provide informed consent and undergo eligibility confirmation (high-risk per Briganti 2019; post-RP without ePLND; enrollment ≤12 weeks after surgery). Receive darolutamide + ADT according to protocol (GnRH agonist; no orchiectomy). Attend scheduled visits for PSA monitoring, safety labs, and adverse-event assessments (CTCAE v5.0). Undergo radiologic evaluations as per protocol to determine rPFS (RECIST 1.1/PCWG3). Complete IPSS and EQ-5D-3L questionnaires at specified time points to assess urinary symptoms and quality of life.
Primary endpoint: 2-year biochemical-recurrence-free rate. Key secondary endpoints: 2-year rPFS; PSA <0.01 ng/mL at 6/12/24 months; treatment-emergent adverse events.
Exploratory endpoints: IPSS and EQ-5D-3L changes over 2 years.
This trial aims to balance oncologic control with quality of life in a population for whom the therapeutic value of ePLND remains uncertain, by testing whether early adjuvant darolutamide + ADT after RP can meaningfully delay recurrence and progression while maintaining acceptable tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daro+ADT | Experimental | Drug: Darolutamide (BAY 1841788)High-risk prostate cancer patients (Briganti 2019 monogram criteria) who did not undergo extended pelvic lymph node dissection (ePLND), will receive Darolutamide 600 mg bid + ADT for 12 months within 12 weeks after RP. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- The patient volunteers to participate and signs the informed consent form (ICF);
- Age 18-75 years (inclusive), male;
- Histologically or cytologically confirmed prostatic adenocarcinoma;
- No non-regional lymph-node metastasis, bone metastasis, or other distant metastasis (e.g., visceral) by conventional imaging (bone scan, CT or MRI) or by PET/CT; i.e., M0;
- High-risk per the Briganti 2019 nomogram, i.e., risk >7%;
Key exclusion criteria (10 listed)
- Histologic features of neuroendocrine differentiation or small-cell carcinoma;
- Prior prostate cancer treatments including any of the following:
- Planned bilateral orchiectomy during the study treatment period;
- Inability to tolerate darolutamide or ADT;
- Concurrent participation in, or planned participation in, another clinical trial;
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 |
|---|---|---|
| Darolutamide (BAY 1841788)Darolutamide 600 mg bid + ADT x 12 months | Drug | Daro+ADT |
Primary outcome
Percentage of patients who remained biochemical recurrence free for 2 years
Time frame: 2 years
biochemical recurrence defined as a PSA increase >0.1 ng/ml above the post-treatment nadir (confirmed by two consecutive measures at least 2 weeks apart), according to NCCN criteria
3 secondary outcomes
2-year rate of radiological progression-free survival (rPFS)
Time frame: 2 years
6-month/ 12-month/ 24-month PSA undetectable rate
Time frame: 2 years
TEAEs
Time frame: 2 years
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 15 Dec 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.
Kan Gong principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Darolutamide (BAY 1841788) in people with Prostate Cancer, run by Peking University First Hospital at 1 site in China.
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 21 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: opening soon, as of the sponsor's last update on 15 Dec 2025. 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 China. 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 Kan Gong ((86)-010-83572075, kan.gong@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who remained biochemical recurrence free for 2 years (time frame: 2 years). 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 15 Dec 2025.