Combination androgen blockade for high-risk prostate cancer
A Randomized Trial of Neoadjuvant Leuprorelin, Darolutamide or Both Prior to Radical Prostatectomy for Intermediate or High-risk Prostate Cancer
This study is testing whether a combination of two prostate cancer treatments can work better than just one before surgery in men with intermediate to high-risk prostate cancer.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Brazilian Clinical Research Institute Academic / other |
| Locations | 6 sites (Feira de Santana, Bahia and 5 other locations) |
| Trial ID | NCT06627530 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of neoadjuvant treatment using leuprorelin, darolutamide, or a combination of both prior to radical prostatectomy in men with intermediate to high-risk prostate cancer. It is a randomized, open-label trial involving 144 patients who will be assigned to one of three treatment arms for 24 weeks. The primary goal is to determine if the combination therapy leads to a better pathological response compared to monotherapy. The study includes blinded endpoint adjudication to ensure unbiased assessment of outcomes.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with histologically confirmed unfavorable intermediate or high-risk non-metastatic prostate adenocarcinoma scheduled for surgery.
Not a fit: Patients with prior prostate cancer treatment or those with neuroendocrine differentiation or small cell features in their cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with high-risk prostate cancer by enhancing pathological response rates.
How similar studies have performed: Other studies have shown promising results with similar neoadjuvant approaches in prostate cancer, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Feira de Santana, Bahia and 5 other locations
- Santa Casa de Misericórdia de Feira de Santana — Feira de Santana, Bahia, Brazil (Recruiting)
- Hospital Ophir Loyola — Belém, Pará, Brazil (Recruiting)
- Hospital São Marcos — Teresina, Piauí, Brazil (Active_not_recruiting)
- Hospital de Clínicas Ijuí — Ijuí, Rio Grande Do Sul, Brazil (Recruiting)
- Hospital Universitário Pedro Ernesto — Rio de Janeiro, Brazil (Recruiting)
- BP - A Beneficência Portuguesa de São Paulo — São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Fernando C Maluf, MD
- Email: maluffc@uol.com.br
- Phone: +55 1159047339
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.