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Trial Title:
COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer
NCT ID:
NCT06627530
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Leuprolide
Conditions: Keywords:
Prostate Cancer
Radical Prostatectomy
Darolutamide
Neoadjuvant
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Darolutamide Oral Tablet
Description:
darolutamide 600 mg PO BID for 24 weeks
Arm group label:
Darolutamide
Arm group label:
Darolutamide + ADT leuprorelin
Intervention type:
Drug
Intervention name:
leuprorelin
Description:
leuprorelin depot 22.5 mg SC every 12 weeks
Arm group label:
Darolutamide + ADT leuprorelin
Arm group label:
Leuprorelin
Summary:
A Randomized Trial of Neoadjuvant Leuprorelin, Darolutamide or Both Prior to Radical
Prostatectomy for Intermediate or High-risk Prostate Cancer. Prospective, randomized,
parallel group, open-label with blinded endpoint adjudication multicenter clinical
trial.To assess, among patients with unfavorable intermediate to high-risk prostate
cancer, whether a neoadjuvant combined treatment with leuprorelin (Leuprorelin) and
darolutamide is superior to monotherapy in terms of complete or almost complete
pathological response.A total of 144 patients with unfavorable intermediate to high-risk
prostate cancer scheduled for radical prostatectomy with extended pelvic lymph node
dissection will be randomized 1:1:1 to oral darolutamide, SC leuprorelin (Leuprorelin) or
both (48 patients per arm) for 24 weeks.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Men ≥18 years of age;
- Histologically confirmed unfavorable intermediate or high/very high risk non
metastatic (by conventional imaging) prostate adenocarcinoma intended for surgery
without neuroendocrine differentiation or small cell features;
- Unfavorable intermediate-risk:
- ISUP grade 3, and/or > 50% positive biopsy cores and/or at least two
intermediate-risk factors. Intermediate-risk factors:
- Clinical tumor stage T2b or T2c (MRI based);
- ISUP grade 2 or 3;
- Prostate-specific antigen (PSA) level of 10-20 ng/mL.
- High-risk or very high-risk:
- ≥cT3a (MRI based) or ISUP 4-5 or PSA>20 ng/mL;
- cN1.
- ECOG 0-1;
- Baseline testosterone > 230 ng/dL;
- No prior prostate cancer treatment;
- Sexually active male subjects must agree to use condoms as an effective barrier
method and refrain from sperm donation, and/or their female partners of reproductive
potential to use a method of effective birth control, during the treatment with
darolutamide and for 1 week after the end of treatment with darolutamide to prevent
pregnancy;
- Written informed consent.
Exclusion Criteria:
- Unresectable prostate cancer;
- Histology of small cell carcinoma prostate cancer or adenocarcinoma with
neuroendocrine features;
- Any prior prostate cancer treatment;
- Any active infection requiring IV antibiotics;
- Known additional malignancy that has a life-expectancy < 2 years;
- Had any of the following within 6 months before randomization: stroke, myocardial
infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass
graft, heart failure with New York Heart Association Class Functional III or IV;
- Uncontrolled severe hypertension as indicated by a resting systolic BP ≥ 180 mmHg or
diastolic BP ≥ 110 mmHg despite medical management;
- A gastrointestinal (GI) disorder or procedure which is expected to interfere
significantly with absorption of darolutamide;
- Inability to swallow oral medications;
- Receipt of medications (e.g. finasteride, dutasteride) or agents that are likely to
alter serum PSA levels within <= 42 days or 5 half-lives prior to registration,
whichever is shorter.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 2024
Completion date:
September 2026
Lead sponsor:
Agency:
Brazilian Clinical Research Institute
Agency class:
Other
Collaborator:
Agency:
Bayer
Agency class:
Industry
Source:
Brazilian Clinical Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06627530
