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Extended Results and Independent Validation of a Phase 2 Trial of Metastasis-Directed Therapy for Molecularly Defined Oligometastatic Prostate Cancer.

التفاصيل البيبلوغرافية
العنوان: Extended Results and Independent Validation of a Phase 2 Trial of Metastasis-Directed Therapy for Molecularly Defined Oligometastatic Prostate Cancer.
المؤلفون: Glicksman RM; Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada; Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada., Ramotar M; Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada., Metser U; Joint Department of Medical Imaging, University Health Network, Mount Sinai Hospital and Women's College Hospital, University of Toronto, Toronto, Ontario, Canada., Chung PW; Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada; Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada., Liu Z; Department of Biostatistics, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada., Vines D; Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada; Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada., Finelli A; Department of Surgical Oncology, Division of Urology, University Health Network, University of Toronto, Toronto, Ontario, Canada., Hamilton R; Department of Surgical Oncology, Division of Urology, University Health Network, University of Toronto, Toronto, Ontario, Canada., Fleshner NE; Department of Surgical Oncology, Division of Urology, University Health Network, University of Toronto, Toronto, Ontario, Canada., Perlis N; Department of Surgical Oncology, Division of Urology, University Health Network, University of Toronto, Toronto, Ontario, Canada., Zlotta AR; Department of Surgical Oncology, Division of Urology, University Health Network, University of Toronto, Toronto, Ontario, Canada., Bayley A; Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada; Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada., Helou J; Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada; Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada., Raman S; Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada; Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada., Kulkarni G; Department of Surgical Oncology, Division of Urology, University Health Network, University of Toronto, Toronto, Ontario, Canada., Catton C; Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada; Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada., Lam T; Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada., Chan R; Joint Department of Medical Imaging, University Health Network, Mount Sinai Hospital and Women's College Hospital, University of Toronto, Toronto, Ontario, Canada., Warde P; Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada; Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada., Gospodarowicz M; Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada; Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada., Jaffray DA; TECHNA Institute, University Health Network, University of Toronto, Toronto, Ontario, Canada; Divisions of Radiation Oncology and Diagnostic Radiology, MD Anderson Cancer Centre, Houston, Texas., Berlin A; Department of Radiation Oncology, University of Toronto, Toronto, Ontario, Canada; Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada; TECHNA Institute, University Health Network, University of Toronto, Toronto, Ontario, Canada. Electronic address: alejandro.berlin@rmp.uhn.ca.
المصدر: International journal of radiation oncology, biology, physics [Int J Radiat Oncol Biol Phys] 2022 Nov 15; Vol. 114 (4), pp. 693-704. Date of Electronic Publication: 2022 Aug 27.
نوع المنشور: Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Elsevier, Inc Country of Publication: United States NLM ID: 7603616 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-355X (Electronic) Linking ISSN: 03603016 NLM ISO Abbreviation: Int J Radiat Oncol Biol Phys Subsets: MEDLINE
أسماء مطبوعة: Publication: New York, NY : Elsevier, Inc
Original Publication: Elmsford, N. Y., Pergamon Press.
مواضيع طبية MeSH: Prostatic Neoplasms*/diagnostic imaging , Prostatic Neoplasms*/pathology , Prostatic Neoplasms*/therapy, Androgen Antagonists/therapeutic use ; Androgens ; Humans ; Male ; Neoplasm Recurrence, Local/radiotherapy ; Positron Emission Tomography Computed Tomography/methods ; Prospective Studies ; Prostate-Specific Antigen ; Tomography, X-Ray Computed
مستخلص: Purpose: The role of metastasis-directed therapy (MDT) in molecularly defined oligorecurrent prostate cancer (PCa) remains irresolute. We present extended follow-up and an independent validation cohort of a prospective trial.
Methods and Materials: This study consists of 2 sequential single-arm phase-2 trials of patients with biochemical recurrence (prostate specific antigen [PSA] 0.4-3.0 ng/mL) and negative conventional imaging after radical prostatectomy and postoperative radiation therapy. All patients underwent [ 18 F]DCFPyL positron emission tomography/computed tomography. Patients with molecularly defined oligorecurrent prostate cancer underwent MDT with stereotactic body radiation therapy or surgery, without androgen deprivation therapy (ADT). The primary end point was biochemical response (≥50% PSA decline from baseline). Secondary end points included PSA progression-free survival and ADT-free survival. The sample size of 37 MDT patients was determined based on a Simon's 2-stage design with biochemical response rate >20%, and this design was also applied for the subsequent independent validation cohort.
Results: Seventy-four patients underwent MDT: 37 each in the initial and validation cohorts. Both cohorts met the prespecified biochemical response rate and completed the planned 2-stages of accrual. For the pooled cohort, the median number of prostate specific membrane antigen positron emission tomography avid lesions was 2 and most (87%) recurrences were nodal. Sixty-four (87%) had stereotactic body radiation therapy and 10 (13%) had surgery. Median follow-up (interquartile range [IQR]) for the initial, validation and combined cohorts were 41 (35-46) months, 14 months (7-21), and 24 months (14-41), respectively. The biochemical response rates for the initial, validation and combined cohorts were 59%, 43%, and 51%, respectively. For the combined cohort, median biochemical progression-free survival was 21 months (95% confidence interval, 13-not reached), and median ADT-free survival was 45 months (95% confidence interval, 31-not reached).
Conclusions: Half of patients treated with MDT for molecularly defined-only oligorecurrent prostate cancer exhibited a biochemical response. This study provides necessary and validated evidence to support randomized trials aiming to determine whether MDT (alone or with systemic therapy) can affect clinically meaningful end points.
(Copyright © 2022 Elsevier Inc. All rights reserved.)
التعليقات: Comment in: Int J Radiat Oncol Biol Phys. 2022 Nov 15;114(4):561-570. (PMID: 36244387)
المشرفين على المادة: 0 (Androgen Antagonists)
0 (Androgens)
EC 3.4.21.77 (Prostate-Specific Antigen)
تواريخ الأحداث: Date Created: 20220828 Date Completed: 20221018 Latest Revision: 20221103
رمز التحديث: 20221213
DOI: 10.1016/j.ijrobp.2022.06.080
PMID: 36031465
قاعدة البيانات: MEDLINE
الوصف
تدمد:1879-355X
DOI:10.1016/j.ijrobp.2022.06.080