A Phase II Neoadjuvant Study of Darolutamide Plus ADT in Men With Localized Prostate Cancer
NCT ID: NCT06029036
Last Updated: 2023-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
53 participants
INTERVENTIONAL
2023-08-05
2026-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Darolutamide + ADT
Duration of treatment: 28-day cycle of darolutamide treatment and 6 cycles of neoadjuvant therapy.
Darolutamide+ADT
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
Interventions
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Darolutamide+ADT
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
Eligibility Criteria
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Inclusion Criteria
2. Able to Sign informed consent form independently.
3. Non-metastatic adenocarcinoma of the prostate.
4. 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.
5. Subjects with pelvic lymph node involvement(N1) can be included.
6. Candidate for radical prostatectomy with or without pelvic lymph node dissection as per the investigator.
7. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
8. 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.
Exclusion Criteria
2. Distant metastasis based on conventional imaging (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion.
3. History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer.
4. Subjects who are planning bilateral orchidectomy during the treatment period of the study.
5. Intolerable with darolutamide or ADT treatment.
6. Candidates of other clinical trials.
7. Any prior malignancy within 5 years.
8. Complications include significant cardiovascular disease, active infection, astrointestinal disorders, or any other complications that in the opinion of the investigator.
9. Any condition that in the opinion of the investigator would preclude participation in this study.
18 Years
75 Years
MALE
No
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
The First Affiliated Hospital of Air Force Medicial University
OTHER
Peking University First Hospital
OTHER
Responsible Party
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Locations
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Peking University First Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Zhisong He, MD
Role: primary
Kaiwei Yang, MD
Role: backup
Other Identifiers
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22440
Identifier Type: -
Identifier Source: org_study_id