Actively Recruiting
A Phase II Neoadjuvant Study of Darolutamide Plus ADT in Men With Localized Prostate Cancer
Led by Peking University First Hospital · Updated on 2023-12-12
53
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
Sponsors
P
Peking University First Hospital
Lead Sponsor
T
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Phase II Neoadjuvant Study of Darolutamide Plus ADT in Men With Localized Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male 18 years or older
- Able to sign informed consent independently
- Diagnosed with non-metastatic adenocarcinoma of the prostate
- Must have at least one high-risk feature: Gleason score 8 or higher, PSA greater than 20 ng/ml, or clinical stage T3a or higher
- May include patients with pelvic lymph node involvement (N1)
- Suitable candidate for radical prostatectomy with or without pelvic lymph node dissection
- ECOG Performance Status of 0 or 1
- Normal organ and marrow function as defined by specific blood and biochemical criteria
You will not qualify if you...
- Prostate cancer with neuroendocrine differentiation or small cell features
- Distant metastasis (clinical stage M1); nodal disease below iliac bifurcation is allowed
- Prior systemic or local treatment for prostate cancer, including pelvic radiation
- Planning bilateral orchidectomy during study treatment
- Intolerance to darolutamide or ADT
- Participation in other clinical trials
- Any prior malignancy within 5 years
- Significant cardiovascular disease, active infection, gastrointestinal disorders, or other serious complications
- Any condition that would prevent safe participation as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, China
Actively Recruiting
Research Team
Z
Zhisong He, MD
CONTACT
K
Kaiwei Yang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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