Prostate CancerPhase 2NCT06029036
A Phase II Neoadjuvant Study of Darolutamide Plus ADT in Men With Localized Prostate Cancer
A Phase 2 study testing Darolutamide+ADT in people with Prostate Cancer, run by Peking University First Hospital at 1 site in China.
Trial summary
Scientific Rationale: High risk localized prostate cancer (PCa) is associated with higher rates of biochemical recurrence, clinical recurrence, metastasis and PCa-specific death. 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+ADT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2023to 31 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Male ≥18 years of age.
- Able to Sign informed consent form independently.
- Non-metastatic adenocarcinoma of the prostate.
- Subjects must have as least one of the following features according to NCCN definition of high-risk: Gleason score ≥8, or PSA >20ng/ml,or≥clinical T3a.
- Subjects with pelvic lymph node involvement(N1) can be included.
- Candidate for radical prostatectomy with or without pelvic lymph node dissection as per the investigator.
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- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Subjects must have normal organ and marrow function as defined below:
- Hemoglobin ≥ 9.0 g/dL;Absolute neutrophil count (ANC) ≥ 1,500/mcL; Platelets ≥ 100,000/mcL, independent of transfusions/growth factors within 3 months of treatment start; Serum potassium ≥ 3.5 mmol/L; Serum total bilirubin ≤ 2.0 x upper limit of normal (ULN) (except in subjects with Gilbert's syndrome who have a total bilirubin > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible);Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN;Serum albumin ≥ 3.0 g/dL;Serum creatinine < 2.0 x ULN.
Who cannot join
- Prostate cancer with neuroendocrine differentiation or small cell features
- Distant metastasis based on conventional imaging (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion.
- History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer.
- Subjects who are planning bilateral orchidectomy during the treatment period of the study.
- Intolerable with darolutamide or ADT treatment.
- Candidates of other clinical trials.
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- Any prior malignancy within 5 years.
- Complications include significant cardiovascular disease, active infection, astrointestinal disorders, or any other complications that in the opinion of the investigator.
- Any condition that in the opinion of the investigator would preclude participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing
Zhisong He, MD, +8610-83572418, wyj7074@sohu.com
Kaiwei Yang, MD, 13811501435, 13811501435@163.com
About this study
Official title: A Phase II, Multi-center, Single-arm, Prospective Study of Darolutamide + ADT Prior to Radical Prostatectomy (RP) in High-risk/Very High-risk Localized Prostate Cancer
Scientific Rationale: High risk localized prostate cancer (PCa) is associated with higher rates of biochemical recurrence, clinical recurrence, metastasis and PCa-specific death. Novel hormone therapies(NHT) have shown a significant survival advantage with respect to classical ADT in later stages of PCa and have already been investigated in neoadjuvant setting.
PURPOSE: To assess antitumor effect by measuring pathological tumor volume with pathological downstaging following radical prostatectomy + pelvic lymph-node dissection (RP + PLND) for high-risk localized prostate cancer patients.
- Conditions
- Prostate Cancer
- Being tested
- Darolutamide+ADT
- 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+ADTDrug
Drug: Darolutamide
Darolutamide 600 mg, (two 300 mg tablets) administered orally twice daily. Swallow tablets whole. Take Darolutamide with food.
Drug: ADT GnRH agonist per physicians' choice, orchiectomy is excluded
| Study group | Role | What they receive |
|---|---|---|
| Darolutamide + ADT | Experimental | Duration of treatment: 28-day cycle of darolutamide treatment and 6 cycles of neoadjuvant therapy. Receives: Drug: Darolutamide+ADT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of pathological downstaging
Percentage of patients with tumor downstaging
Measured: 6 months
Secondary outcomes (7)
pCR or MRD
Pathologic complete response or Minimal Residual Disease(defined as overall diameter <5 mm)
Measured: 6 months
PSM
Percentage of patients with positive surgical margins
Measured: 6 months
Rate of peri-operative complications
including delay in surgery, intra-operative complications, and postoperative complications
Measured: within 30 days of surgery
Biochemical complete response
PSA <0.1ng/ml prior to RP
Measured: 6 months
PSA undetectable rate
PSA<0.02 ng/ml
Measured: 12 months post-RP
2-year biochemical progression-free survival, bPFS
PSA>0.2 ng/ml
Measured: 24 months post-RP
AEs/SAEs
The level of AEs defined by NCI-CTCAE v5.0. Safety assessments will be assessed and documented after initiation of study drug, regardless of relationship to study drug.
Measured: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start5 Aug 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2026 (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
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Air Force Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029036
- Sponsor's protocol ID
- 22440
- Status last verified
- Mar 2023
- First submitted
- 1 Sep 2023
- Last updated
- 12 Dec 2023
- 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 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multi-center, Single-arm, Prospective Study of Darolutamide + ADT Prior to Radical Prostatectomy (RP) in High-risk/Very High-risk Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT06029036
- Acronym / sponsor ID
- 22440
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Air Force Medical University
- Study start
- 5 Aug 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 8 Sep 2023 (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.
Scientific Rationale: High risk localized prostate cancer (PCa) is associated with higher rates of biochemical recurrence, clinical recurrence, metastasis and PCa-specific death. Novel hormone therapies(NHT) have shown a significant survival advantage with respect to classical ADT in later stages of PCa and have already been investigated in neoadjuvant setting.
PURPOSE: To assess antitumor effect by measuring pathological tumor volume with pathological downstaging following radical prostatectomy + pelvic lymph-node dissection (RP + PLND) for high-risk localized prostate cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Darolutamide + ADT | Experimental | Drug: Darolutamide+ADTDuration of treatment: 28-day cycle of darolutamide treatment and 6 cycles of neoadjuvant therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male ≥18 years of age.
- Able to Sign informed consent form independently.
- Non-metastatic adenocarcinoma of the prostate.
- Subjects must have as least one of the following features according to NCCN definition of high-risk: Gleason score ≥8, or PSA >20ng/ml,or≥clinical T3a.
- Subjects with pelvic lymph node involvement(N1) can be included.
Key exclusion criteria (9 listed)
- Prostate cancer with neuroendocrine differentiation or small cell features
- Distant metastasis based on conventional imaging (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion.
- History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer.
- Subjects who are planning bilateral orchidectomy during the treatment period of the study.
- Intolerable with darolutamide or ADT 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 |
|---|---|---|
| Darolutamide+ADTDrug: Darolutamide Darolutamide 600 mg, (two 300 mg tablets) administered orally twice daily. Swallow tablets whole. Take Darolutamide with food. Drug: ADT GnRH agonist per physicians' choice, orchiectomy is excluded | Drug | Darolutamide + ADT |
Primary outcome
Rate of pathological downstaging
Time frame: 6 months
Percentage of patients with tumor downstaging
7 secondary outcomes
pCR or MRD
Time frame: 6 months
PSM
Time frame: 6 months
Rate of peri-operative complications
Time frame: within 30 days of surgery
Biochemical complete response
Time frame: 6 months
PSA undetectable rate
Time frame: 12 months post-RP
2-year biochemical progression-free survival, bPFS
Time frame: 24 months post-RP
AEs/SAEs
Time frame: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- 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.
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+ADT 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 9 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 12 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhisong He, MD (+8610-83572418, wyj7074@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of pathological downstaging (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 12 Dec 2023.