Prostate CancerPhase 2NCT06575257
Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer
A Phase 2 study testing Darolutamide and Goserelin 3.6 mg in people with Prostate Cancer, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine if treatment with Darolutamide plus androgen deprivation therapy (ADT) before radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete… 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 and Goserelin 3.6 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to May 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
- Patients must be ≥ 18 and ≤75 years of age.
- All patients must have a histologically or cytologically diagnosis of prostate cancer and must be eligible for radical prostatectomy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤1.
- All patients must complete mpMRI or 68Ga-PSMA PET / CT before and after neoadjuvant treatment.
- All patients must undergo thorough tumor staging and meet one of the following criteria: 1. multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor ≥ cT2c or cN+or locally advanced, 2. Gleason score of primary tumor ≥ 8, 3. prostate specific antigen (PSA) ≥20 ng/ml.
- Patients must have adequate organ function as defined by the following criteria(within 28 days prior to registration):
- white blood cell (WBC) ≥ 4.0 × 109 / L platelets≥ 100 × 109 / L hemoglobin ≥ 9 g / dL international normalized ratio (INR) < 1.5. total bilirubin (TBIL)≤1.5 x upper limit of normal (ULN) SGOT (AST) and SGPT (ALT) ≤ 2.5 x ULN serum creatinine ≤2×ULN
- Patients must participate voluntarily and sign an informed consent form (ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must be willing to obey the prohibitions and restrictions specified in the research protocol.
Who cannot join
- clinical or radiological evidence of regional or extra-regional lymph node metastases or bone metastases or visceral metastases.
- Prior androgen deprivation therapy (medical or surgical) or focal treatment of prostate cancer or prostate cancer radiotherapy or prostate cancer chemotherapy.
- severe or uncontrolled concurrent infections.
- New York Heart Association Class III or IV congestive heart failure at the time of screening.
- uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
- Patients with mental illness, mental disability or inability to give informed consent are not eligible.
- Patients have had other malignancies other than prostate cancer in the past 5 years, but cured basal cell or squamous cell skin cancers can be enrolled.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jingliang Zhang, MD contact
China1 site, 1 recruiting
- Recruiting
The First Affillated Hospital, the Air Force Medical University
Xi’an, Shanxi, 710032
About this study
Official title: Neoadjuvant ADT +/- Darolutamide Followed by Radical Prostatectomy for High-risk Prostate Cancer: a Randomized, Open Label Trial
The purpose of this study is to determine if treatment with Darolutamide plus androgen deprivation therapy (ADT) before radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and pathological tumor volume with minimal residual disease (MRD)) as compared to ADT.
- Conditions
- Prostate Cancer
- Being tested
- Darolutamide, Goserelin 3.6 mg
- 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
600 mg orally twice daily for 12 weeks before radical prostatectomy
Goserelin 3.6 mgDrug
3.6 mg goserelin hypodermic once per 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Darolutamide Plus ADT | Experimental | All participants in this arm will receive luteinizing hormone releasing hormone analogue (LHRHa) plus Darolutamide. Goserelin 3.6 mg will be used once per 4 weeks. Darolutamide will be administered orally as 600 mg twice a day. Subjects will continue to take Darolutamide Plus Goserelin for 12 weeks before radical prostatectomy Receives: Drug: Darolutamide; Drug: Goserelin 3.6 mg |
| ADT alone | Experimental | All participants in this arm will receive LHRHa alone for 12 weeks before receiving radical prostatectomy. Goserelin 3.6 mg will be administered once per 4 weeks. Receives: Drug: Goserelin 3.6 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response Rate
The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy
Measured: After 12 weeks of neoadjuvant therapy + RP + PLND
Proportion of Subjects With Minimal Residual Disease
The proportion of subjects that have residual tumors with maximum diameter of 5 mm or less after radical prostatectomy
Measured: After 12 weeks of neoadjuvant therapy + RP + PLND
Secondary outcomes (8)
Rate of Stage Degradation
Clinical or pathological stage degradation after neoadjuvant therapy
Measured: After 12 weeks of neoadjuvant therapy + RP + PLND
Rate of Positive Surgical Margins
The proportion of subjects with positive surgical margins after radical prostatectomy
Measured: After 12 weeks of neoadjuvant therapy + RP + PLND
Rate of Complete Serum Remission
The proportion of subjects whose PSA is less than or equal to 0.2 ng/ml after 3 months of treatment
Measured: After 12 weeks of neoadjuvant therapy
Proportion of subjects without PSA progression
The proportion of subjects whose PSA has never gone below 1 ng/ml or who receive any radiotherapy or systemic treatment after radical prostatectomy
Measured: 2 years after RP
Imaging Response Rate
The proportion of subjects whose primary tumor is in complete remission on imaging or residual tumor's maximum diameter is less than 0.5cm
Measured: After 12 weeks of neoadjuvant therapy
Recovery time of urinary continence (day)
The recovery time of urinary continence (day) after radical prostatectomy, defined as 0 pad/day.
Measured: 1 years after RP
biochemical recurrence-free survival (bRFS)
biochemical recurrence-free survival (bRFS) defined as time to PSA ≥ 0.2 ng/ml after radical prostatectomy.
Measured: 3 years after RP
metastasis-free survival (MFS)
time from date of randomization to date of evidence of systemic disease on bone scan or cross-sectional imaging.
Measured: 5 years after RP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start1 May 2024
- Primary completionMay 2026 (estimated)
- Study completionMay 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 Xijing 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weijun Qin, MD, Principal investigator, The First Affillated Hospital, the Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575257
- Sponsor's protocol ID
- KY20242118-C-1
- Status last verified
- Jun 2024
- First submitted
- 26 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- 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 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant ADT +/- Darolutamide Followed by Radical Prostatectomy for High-risk Prostate Cancer: a Randomized, Open Label Trial
- ClinicalTrials.gov ID
- NCT06575257
- Acronym / sponsor ID
- KY20242118-C-1
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 28 Aug 2024 (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 purpose of this study is to determine if treatment with Darolutamide plus androgen deprivation therapy (ADT) before radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and pathological tumor volume with minimal residual disease (MRD)) as compared to ADT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Darolutamide Plus ADT | Experimental | Drug: Darolutamide, Drug: Goserelin 3.6 mgAll participants in this arm will receive luteinizing hormone releasing hormone analogue (LHRHa) plus Darolutamide. Goserelin 3.6 mg will be used once per 4 weeks. Darolutamide will be administered orally as 600 mg twice a day. Subjects will continue to take Darolutamide Plus Goserelin for 12 weeks before radical prostatectomy |
| ADT alone | Experimental | Drug: Goserelin 3.6 mgAll participants in this arm will receive LHRHa alone for 12 weeks before receiving radical prostatectomy. Goserelin 3.6 mg will be administered once per 4 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must be ≥ 18 and ≤75 years of age.
- All patients must have a histologically or cytologically diagnosis of prostate cancer and must be eligible for radical prostatectomy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤1.
- All patients must complete mpMRI or 68Ga-PSMA PET / CT before and after neoadjuvant treatment.
- All patients must undergo thorough tumor staging and meet one of the following criteria: 1. multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor ≥ cT2c or cN+or locally advanced, 2. Gleason score of primary tumor ≥ 8, 3. prostate specific antigen (PSA) ≥20 ng/ml.
Key exclusion criteria (7 listed)
- clinical or radiological evidence of regional or extra-regional lymph node metastases or bone metastases or visceral metastases.
- Prior androgen deprivation therapy (medical or surgical) or focal treatment of prostate cancer or prostate cancer radiotherapy or prostate cancer chemotherapy.
- severe or uncontrolled concurrent infections.
- New York Heart Association Class III or IV congestive heart failure at the time of screening.
- uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
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 |
|---|---|---|
| Darolutamide600 mg orally twice daily for 12 weeks before radical prostatectomy | Drug | Darolutamide Plus ADT |
| Goserelin 3.6 mg3.6 mg goserelin hypodermic once per 4 weeks | Drug | ADT alone, Darolutamide Plus ADT |
Primary outcome
Pathologic Complete Response Rate
Time frame: After 12 weeks of neoadjuvant therapy + RP + PLND
The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy
Proportion of Subjects With Minimal Residual Disease
Time frame: After 12 weeks of neoadjuvant therapy + RP + PLND
The proportion of subjects that have residual tumors with maximum diameter of 5 mm or less after radical prostatectomy
8 secondary outcomes
Rate of Stage Degradation
Time frame: After 12 weeks of neoadjuvant therapy + RP + PLND
Rate of Positive Surgical Margins
Time frame: After 12 weeks of neoadjuvant therapy + RP + PLND
Rate of Complete Serum Remission
Time frame: After 12 weeks of neoadjuvant therapy
Proportion of subjects without PSA progression
Time frame: 2 years after RP
Imaging Response Rate
Time frame: After 12 weeks of neoadjuvant therapy
Recovery time of urinary continence (day)
Time frame: 1 years after RP
biochemical recurrence-free survival (bRFS)
Time frame: 3 years after RP
metastasis-free survival (MFS)
Time frame: 5 years after RP
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 28 Aug 2024.
- 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.
Jingliang Zhang, MD contact
Weijun Qin, MD principal investigator
The First Affillated Hospital, the Air Force Medical University
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 Goserelin 3.6 mg in people with Prostate Cancer, run by Xijing 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 8 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 28 Aug 2024. 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 Weijun Qin, MD (029-84771579, qinwj@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response Rate (time frame: After 12 weeks of neoadjuvant therapy + RP + PLND). 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 28 Aug 2024.