1. Systemic and Tumor-directed Therapy for Oligorecurrent Metastatic Prostate Cancer (SATURN): Primary Endpoint Results from a Phase 2 Clinical Trial.
- Author
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Nikitas, John, Rettig, Matthew, Shen, John, Reiter, Robert, Lee, Alan, Steinberg, Michael, Valle, Luca, Sachdeva, Ankush, Romero, Tahmineh, Calais, Jeremie, Czernin, Johannes, Nickols, Nicholas, and Kishan, Amar
- Subjects
Abiraterone acetate ,Androgen annihilation therapy ,Apalutamide ,Leuprolide ,Metastasis-directed therapy ,Oligorecurrence ,Prostate cancer ,Stereotactic body radiotherapy ,Humans ,Male ,Prostatic Neoplasms ,Aged ,Leuprolide ,Radiosurgery ,Neoplasm Recurrence ,Local ,Middle Aged ,Abiraterone Acetate ,Thiohydantoins ,Prednisone ,Prostate-Specific Antigen ,Neoplasm Metastasis ,Antineoplastic Combined Chemotherapy Protocols ,Combined Modality Therapy ,Androgen Antagonists ,Treatment Outcome ,Antineoplastic Agents ,Hormonal - Abstract
Nearly all men with metastatic hormone-sensitive prostate cancer treated with intermittent androgen deprivation therapy (ADT) experience recurrence within 6 mo of testosterone recovery. We conducted a single-arm phase 2 trial to evaluate whether addition of dual androgen receptor pathway inhibitors (ARPIs) and metastasis-directed stereotactic body radiotherapy (SBRT) to intermittent ADT improves recurrence rates for men with between one and five nonvisceral, extrapelvic metastases on prostate-specific membrane antigen positron emission tomography/computed tomography after prior radical prostatectomy. Patients received 6 mo of androgen annihilation therapy (AAT; leuprolide, abiraterone acetate plus prednisone, and apalutamide) and metastasis-directed SBRT. The primary endpoint was the percentage of patients with prostate-specific antigen (PSA)
- Published
- 2024