Prostate CancerPhase 2ANDARPNCT07476677
Darolutamide ± ADT as Neoadjuvant Therapy in High-Risk/Very High-Risk Localized Prostate Cancer
A Phase 2 study testing Darolutamide and Darolutamide combined with ADT in people with Prostate Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a two-Parallel cohort, prospective study, aimed to explore Efficacy and safety of neoadjuvant Darolutamide with or without ADT in high-risk/very high-risk localized-stage prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Darolutamide and Darolutamide combined with ADT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Mar 2028
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent was provided before the initiation of either study procedure
- Age between 18 and 80 years of age (including 18 and 80 years of age)
- ECOG performance status of 0-1 points, without severe cardiovascular and psychiatric disorders
- Histologically confirmed adenocarcinoma of the prostate
- Any one of the following conditions:
- 1) Clinical T stage ≥cT3; 2) Gleason score 8-10; 3) baseline PSA ≥20ng/ml; 4) presence of regional lymph node cN1; 6. No previous topical therapy and chemotherapy, ARi2nd 7. Patients previously treated with conventional ADT for ≤6 months (±ARi1st) 8. Subjects meet the criteria for resectability.The resectability criteria were defined as: clear lateral border of prostate and clear and non-invasive bladder neck on rectal digital examination
- a, and no urethral or external sphincter invasion of the prostate apex 9. The subject has not received local treatment of the primary lesion of prostate cancer in the past and has no contraindications to radical prostatectomy 10. Male subjects have undergone surgical sterilization or used acceptable contraceptive methods (defined as barrier contraception containing spermicide) during the duration of the study and 3 months after the last study drug administration to prevent their partner from getting pregnant 11. Blood donor subjects are not allowed to donate blood during the study period and during the 3 months after the last study drug administration 12. During the duration of the study (including treatment and planned visits and examinations), subjects voluntarily and able to comply with the protocol
Who cannot join
- Staff members involved in planning and/or conducting this study (research center staff).
- Previously participated in the current study.
- Participated in another clinical study involving an investigational product (IP) in the past month.
- Previously underwent surgical castration or chemotherapy.
- Previously received PARP inhibitor treatment.
- Subjects with known hypersensitivity to ADT drugs/darolutamide or any excipient in the product.
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- Subjects with psychiatric or physical conditions that, in the investigator's judgment, would prevent them from safely receiving treatment.
- Subjects with any laboratory test abnormalities that, in the investigator's judgment, would put them at risk if they participated in the study.
- Subjects with persistent toxicity from prior cancer treatment (> CTCAE Grade 2), except for alopecia.
- Patients with known active hepatitis (i.e., hepatitis B or hepatitis C) due to the risk of bloodborne or other bodily fluid transmission.
- Immunocompromised subjects, such as those known to be HIV seropositive.
- Unwilling or unable to comply with protocol requirements and scheduled visits.
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
Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, 101205
Jun Xiong Ye
About this study
Official title: A Phase II Prospective, Open-Label Clinical Study of Darolutamide ± ADT as Neoadjuvant Therapy in High-Risk/Very High-Risk Localized Prostate Cancer
This is a two-Parallel cohort, prospective study, aimed to explore Efficacy and safety of neoadjuvant Darolutamide with or without ADT in high-risk/very high-risk localized-stage prostate cancer. Two parallel cohorts will enroll 30 patients with high-risk/very high-risk localized-stage prostate cancer according to the criteria, respectively. Eligible patients in cohort 1 will receive 600 mg of Darolutamide orally daily, and patients in cohort 2 will receive 600 mg of Darolutamide orally daily combined with ADT. The selection of the two parallel cohorts will be determined by the clinician. Considering that ADT treatment will bring typical adverse-reactions such as hot flashes, gynecomastia, fatigue, and sexual dysfunction, the clinician will decide the enrollment cohort based on the patient's specific clinical condition. After both cohorts receive 3-6 months of neoadjuvant treatment, these patients will receive robotic-assisted laparoscopic prostatectomy (RALP) ± standard lymph node dissection (LND), and the specific surgical plan will be formulated by the clinician. Patients will receive postoperative adjuvant therapy as same as the original prescription according to different conditions (the application of postoperative adjuvant radiotherapy is determined by the clinician). Follow-up: (1) PSA and testosterone levels: Monitor monthly for the first 6 months. Monitor every 3 months within 2 years. Monitor every 6 months thereafter. (2) Radiological evaluation: Monitor every 6 minutes within 2 years after surgery, and every 12 minutes thereafter.
Read the detailed description
Purpose Main research objectives: To explore the efficacy and safety of neoadjuvant Darolutamide monotherapy and Darolutamide combined with ADT followed by radical prostatectomy in two Parallel cohorts of High-risk/very high-risk localized-stage prostate cancer patients.
Secondary study objectives: To explore the efficacy and safety of neoadjuvant Darolutamide monotherapy and Darolutamide combined with ADT followed by radical prostatectomy in two Parallel cohorts of High-risk/very high-risk localized-stage prostate cancer patients.
Exploratory research objectives: The predictive effect of PSMA PET (SUVmax) and CTC (Circulating tumor cells) on curative effect and the value of monitoring recurrence after radical resection; Main Outcomes: The proportion of patients achieving MRD (minimal residual disease) in two parallel cohorts.
Secondary Outcomes: Pathological downstaging rate, pCR rate (pathological complete remission), positive margin rate, proportion of undetectable PSA, bPFS (biochemical progression-free survival), MFS (metastasis-free survival), quality of life questionnaire Exploratory Outcomes: Biomarkers related to efficacy; Analysis of CTC status; exploration of the correlation between SUVmax measured by PSMA-PET and prognosis.
Target treatment subject population:
The target population of this study is patients diagnosed with high-risk/very high-risk localized-stage prostate cancer (Meet one of the following conditions):
Clinical T stage ≥cT3; Gleason score 8-10 points; baseline PSA ≥20ng/ml; regional lymph node cN1;
Planned duration of treatment:
The duration of neoadjuvant therapy in this study will be 3 to 6 months, and the follow-up period will be 2 years.
Eligible patients will receive: Parallel cohort 1: daily oral administration of Darolutamide 600 mg; Parallel cohort 2: daily oral administration of darolutamide 600 mg combined with ADT drugs (no restriction on drug categories, including LHRH agonists/LHRH antagonists, the specific dosage is determined according to the actual situation), for 3 to 6 months. The selection of the two parallel cohorts is determined by the clinician. Considering that ADT treatment can cause typical adverse reactions such as hot flashes, gynecomastia, fatigue, sexual dysfunction, etc., the clinician will decide the enrollment cohort based on the patient's specific clinical condition. Subjects will undergo robotic-assisted laparoscopic prostatectomy (RALP) ± standard lymph node dissection (LND), followed by a 2-year follow-up.
Study drugs, dosage and administration route:
The study drug is Darolutamide 600 mg, taken orally twice a day; ADT drug (the specific dosage is determined according to the actual instructions).
Statistical methods:
Primary endpoint: Proportion of patients achieving MRD (minimal residual disease) in two parallel cohorts.
Secondary study endpoints: pCR rate (pathological complete remission), pathological downstaging rate, positive resection margin rate, proportion of PSA undetectable 8 weeks after surgery, biochemical progression-free survival (bPFS), metastasis-free survival (MFS), and quality of life questionnaire.
Data will be summarized using appropriate descriptive statistics. Continuous variables will be summarized using number of observations (n), mean (or geometric mean, if appropriate), standard deviation (SD), median, quartiles (Q1 and Q3), minimum and maximum. Categorical variables will be summarized using frequencies and percentages for each category. 95% CIs will be provided where appropriate.
- Conditions
- Prostate Cancer
- Being tested
- Darolutamide, Darolutamide combined with ADT
- Keywords
- localized-stage prostate cancer, Darolutamide, neoadjuvant
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarolutamideDrug
daily oral administration of Darolutamide 600 mg
Darolutamide combined with ADTDrug
600 mg of Darolutamide orally daily combined with ADT
| Study group | Role | What they receive |
|---|---|---|
| Darolutamide | Active comparator | A Group treated with Darolutamide 600 mg Receives: Drug: Darolutamide |
| Darolutamide combined with ADT | Experimental | A Group treated with Darolutamide combined with ADT Receives: Drug: Darolutamide combined with ADT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main Outcome
Number of Participants Achieving Minimal Residual Disease (MRD) Positivity
Measured: 6 months
Secondary outcomes (6)
Pathological complete response (pCR) rate
Proportion of participants achieving pathological complete response (pCR) as assessed by central pathology review
Measured: 6 months
Positive surgical margin rate
Proportion of participants with positive surgical margins on final pathology report.
Measured: 6 months
Proportion of participants with undetectable PSA
Proportion of participants achieving undetectable PSA level (typically <0.2 ng/mL, assay-dependent)
Measured: 6 months
Biochemical progression-free survival (bPFS)
Time from surgery to biochemical progression (defined as PSA ≥0.2 ng/mL confirmed by a second measurement) or death from any cause
Measured: 1 year
Metastasis-free survival (MFS)
Time from surgery to radiographic evidence of distant metastasis or death from any cause.
Measured: 1 year
Quality of life score
Score on the Expanded Prostate Cancer Index Composite (EPIC)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (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 Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476677
- Sponsor's protocol ID
- 24/605-4885
- Acronym
- ANDARP
- Status last verified
- Mar 2025
- First submitted
- 24 Sep 2025
- Last updated
- 17 Mar 2026
- 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 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Prospective, Open-Label Clinical Study of Darolutamide ± ADT as Neoadjuvant Therapy in High-Risk/Very High-Risk Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT07476677
- Acronym / sponsor ID
- ANDARP / 24/605-4885
- Conditions
- Prostate Cancer
- Keywords
- localized-stage prostate cancer, Darolutamide, neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 17 Mar 2026 (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.
This is a two-Parallel cohort, prospective study, aimed to explore Efficacy and safety of neoadjuvant Darolutamide with or without ADT in high-risk/very high-risk localized-stage prostate cancer. Two parallel cohorts will enroll 30 patients with high-risk/very high-risk localized-stage prostate cancer according to the criteria, respectively. Eligible patients in cohort 1 will receive 600 mg of Darolutamide orally daily, and patients in cohort 2 will receive 600 mg of Darolutamide orally daily combined with ADT. The selection of the two parallel cohorts will be determined by the clinician. Considering that ADT treatment will bring typical adverse-reactions such as hot flashes, gynecomastia, fatigue, and sexual dysfunction, the clinician will decide the enrollment cohort based on the patient's specific clinical condition. After both cohorts receive 3-6 months of neoadjuvant treatment, these patients will receive robotic-assisted laparoscopic prostatectomy (RALP) ± standard lymph node dissection (LND), and the specific surgical plan will be formulated by the clinician. Patients will receive postoperative adjuvant therapy as same as the original prescription according to different conditions (the application of postoperative adjuvant radiotherapy is determined by the clinician). Follow-up: (1) PSA and testosterone levels: Monitor monthly for the first 6 months. Monitor every 3 months within 2 years. Monitor every 6 months thereafter. (2) Radiological evaluation: Monitor every 6 minutes within 2 years after surgery, and every 12 minutes thereafter.
Detailed description
Purpose Main research objectives: To explore the efficacy and safety of neoadjuvant Darolutamide monotherapy and Darolutamide combined with ADT followed by radical prostatectomy in two Parallel cohorts of High-risk/very high-risk localized-stage prostate cancer patients.
Secondary study objectives: To explore the efficacy and safety of neoadjuvant Darolutamide monotherapy and Darolutamide combined with ADT followed by radical prostatectomy in two Parallel cohorts of High-risk/very high-risk localized-stage prostate cancer patients.
Exploratory research objectives: The predictive effect of PSMA PET (SUVmax) and CTC (Circulating tumor cells) on curative effect and the value of monitoring recurrence after radical resection; Main Outcomes: The proportion of patients achieving MRD (minimal residual disease) in two parallel cohorts.
Secondary Outcomes: Pathological downstaging rate, pCR rate (pathological complete remission), positive margin rate, proportion of undetectable PSA, bPFS (biochemical progression-free survival), MFS (metastasis-free survival), quality of life questionnaire Exploratory Outcomes: Biomarkers related to efficacy; Analysis of CTC status; exploration of the correlation between SUVmax measured by PSMA-PET and prognosis.
Target treatment subject population:
The target population of this study is patients diagnosed with high-risk/very high-risk localized-stage prostate cancer (Meet one of the following conditions):
Clinical T stage ≥cT3; Gleason score 8-10 points; baseline PSA ≥20ng/ml; regional lymph node cN1;
Planned duration of treatment:
The duration of neoadjuvant therapy in this study will be 3 to 6 months, and the follow-up period will be 2 years.
Eligible patients will receive: Parallel cohort 1: daily oral administration of Darolutamide 600 mg; Parallel cohort 2: daily oral administration of darolutamide 600 mg combined with ADT drugs (no restriction on drug categories, including LHRH agonists/LHRH antagonists, the specific dosage is determined according to the actual situation), for 3 to 6 months. The selection of the two parallel cohorts is determined by the clinician. Considering that ADT treatment can cause typical adverse reactions such as hot flashes, gynecomastia, fatigue, sexual dysfunction, etc., the clinician will decide the enrollment cohort based on the patient's specific clinical condition. Subjects will undergo robotic-assisted laparoscopic prostatectomy (RALP) ± standard lymph node dissection (LND), followed by a 2-year follow-up.
Study drugs, dosage and administration route:
The study drug is Darolutamide 600 mg, taken orally twice a day; ADT drug (the specific dosage is determined according to the actual instructions).
Statistical methods:
Primary endpoint: Proportion of patients achieving MRD (minimal residual disease) in two parallel cohorts.
Secondary study endpoints: pCR rate (pathological complete remission), pathological downstaging rate, positive resection margin rate, proportion of PSA undetectable 8 weeks after surgery, biochemical progression-free survival (bPFS), metastasis-free survival (MFS), and quality of life questionnaire.
Data will be summarized using appropriate descriptive statistics. Continuous variables will be summarized using number of observations (n), mean (or geometric mean, if appropriate), standard deviation (SD), median, quartiles (Q1 and Q3), minimum and maximum. Categorical variables will be summarized using frequencies and percentages for each category. 95% CIs will be provided where appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Darolutamide | Active comparator | Drug: DarolutamideA Group treated with Darolutamide 600 mg |
| Darolutamide combined with ADT | Experimental | Drug: Darolutamide combined with ADTA Group treated with Darolutamide combined with ADT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent was provided before the initiation of either study procedure
- Age between 18 and 80 years of age (including 18 and 80 years of age)
- ECOG performance status of 0-1 points, without severe cardiovascular and psychiatric disorders
- Histologically confirmed adenocarcinoma of the prostate
- Any one of the following conditions:
Key exclusion criteria (12 listed)
- Staff members involved in planning and/or conducting this study (research center staff).
- Previously participated in the current study.
- Participated in another clinical study involving an investigational product (IP) in the past month.
- Previously underwent surgical castration or chemotherapy.
- Previously received PARP inhibitor treatment.
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 |
|---|---|---|
| Darolutamidedaily oral administration of Darolutamide 600 mg | Drug | Darolutamide |
| Darolutamide combined with ADT600 mg of Darolutamide orally daily combined with ADT | Drug | Darolutamide combined with ADT |
Primary outcome
Main Outcome
Time frame: 6 months
Number of Participants Achieving Minimal Residual Disease (MRD) Positivity
6 secondary outcomes
Pathological complete response (pCR) rate
Time frame: 6 months
Positive surgical margin rate
Time frame: 6 months
Proportion of participants with undetectable PSA
Time frame: 6 months
Biochemical progression-free survival (bPFS)
Time frame: 1 year
Metastasis-free survival (MFS)
Time frame: 1 year
Quality of life score
Time frame: 1 year
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 17 Mar 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Darolutamide combined with ADT in people with Prostate Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 7 inclusion and 12 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 17 Mar 2026. 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?
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?
Main Outcome (time frame: 6 months). 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 17 Mar 2026.