At a glance
ClinicalIndex Comparison Record- ✓Adenocarcinoma of the prostate resectable after systemic therapy; Ductal adenocarcinoma permitted
- ✓Acceptable surgical risk and commitment to radical prostatectomy after pre-surgical therapy
- ✓Lymph node metastasis demonstrated by biopsy/dissection OR non-bulky (<5 cm) regional pelvic/distant lymphadenopathy on imaging
- ✓Prior hormonal therapy (LHRH agonist/antagonist ± first-generation antiandrogen) up to 6 weeks permitted
- ✕Biopsy-proven small cell or sarcomatoid histology
- ✕Clinical or radiological evidence of bone or other extranodal metastasis
- ✕Prior chemotherapy, experimental agents for prostate cancer, or >4 weeks prior ADT
- ✕Estrogens, cyproterone acetate, or glucocorticoids >10 mg/day prednisone equivalent in 4 weeks prior to Day 1
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in de Novo Metastatic to Lymph Nodes Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating ADT, Enzalutamide, and 3 other interventions for Prostate Cancer. Currently recruiting, targeting 30 participants across 1 site.
Detailed Summary
To learn about the effectiveness of adding talazoparib to the standard of care treatment combination of androgen ablation therapy (hormone therapy, also known as ADT) and enzalutamide in patients with prostate cancer that has spread into the lymph nodes.
Study Details
Timeline
Arms & Interventions
Participant will recive ADT plus Enzalutamide for a total of 8 weeks. After about 8 weeks of ADT and Enzalutamide treatment, participant will begin taking Talazoparib
Interventions
Given by PO
Given by PO
Given by PO
Given PO or given INJ
Given PO or given INJ