Prospective monitoring of biochemically recurrent prostate cancer (BCR) using prostate specific membrane antigen (PSMA) imaging: 21-month follow-up.
Abstract
37 Background: The use of PSMA imaging is impacting the management of BCR, but it remains unclear if treatment escalation is required for PSMA+ BCR. While patients (pts) at the highest risk of death from prostate cancer (e.g. PSA Doubling Time (DT) less than 6 months) may benefit from therapy, the majority of BCR pts will not die of prostate cancer. Longitudinal data pf PSMA+ BCR is required to better understand risk stratification for PSMA+ BCR. Methods: NCT05588128 enrolls BCR pts after definitive therapy +/- salvage options. Pts are required to have a PSA>0.5 ng/ml, negative bone scan and computed tomography (CT; lymph nodes (LNs) up to 1.5 cm are permitted.) Prior therapies are permitted as long as testosterone>100 ng/dL. If initial PSMA scan is positive, PSMA scan is repeated every 6 months, but annually if negative. While on-study, patients may have systemic therapy for less than 6 month intervals and radiation (RT) is permitted. Results: 129 patients are evaluable with a median potential follow-up of 21.75 months (mos). Median baseline age=71 years, PSA=2.3 ng/ml and PSA DT=11.0 mos but 35% have PSA DT <6 mos. At baseline 23 pts (18%) had negative PSMA, 22 (17%) had prostate only findings, 24 (19%) had 1 LN, 9 (7%) had 2-3 LNs and 33 (26%) had 4+ LNs. Also, 19 pts (15%) had bone findings, 4 (3%) had PSMA+ serosal lesions and 1pt had PSMA+ pulmonary nodule. During the course of follow-up, 28 pts elected androgen deprivation therapy (ADT)-sparing NCI protocols, 1 pt had ADT, 1 pt had salvage RT, and 7 had RT to PSMA+ finding(s). Of 107 pts with PSMA+ findings, only 4 (3.7%) had developed metastasis on CT/bone scan with a median f/u of 21.75 mos. Conclusions: Most patients with BCR will not die of prostate cancer and it remains unclear how PSMA imaging will help risk stratify pts. This ongoing study demonstrates that with nearly 2 years of median follow-up, the risk of metastatic progression on CT or bone scan remains low even if patients have PSMA+ findings at baseline. These data do not support using PSMA imaging as the sole criteria to initiate therapy for BCR pts including those with numerous PSMA findings. This study continues to accrue patients at the National Cancer Institute, Bethesda, MD. Clinical trial information: NCT05588128 .
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (20)
Ravi Amrit Madan
Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD
Esther Mena
1National Cancer Institute, Lymphoid Malignancies Branch, Bethesda, United States
Liza Lindenberg
National Institutes of Health, Bethesda, MD
Megan Hausler
Genitourinary Malignancies Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD
Monique Williams
Genitourinary Malignancies Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD
Amy Hankin
Genitourinary Malignancies Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD
Jeanny B. Aragon-Ching
Inova Schar Cancer Institute, Fairfax, VA
Laura A. Sena
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University School of Medicine, Baltimore, MD
Russell Kent Pachynski
Washington University School of Medicine, St. Louis, MO
Edwin Melencio Posadas
Cedars-Sinai Medical Center, Los Angeles, CA
Helen Moon
From the Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda (A.B.A., N.S., S.N., L.L., L.C.), the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (J.H.-C.), and the Investigational Drug Branch, Cancer Therapy Evaluation Program, National Cancer Institute, National Institutes of Health, Rockville (H.S., E.S.) — all in Maryland; the Alliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN (K.V.B., M.O., C.M., G.P.B.); AdventHealth Cancer Institute and the University of Central Florida, Orlando (G.S.); Dana–Farber/Harvard Cancer Center, Boston (S.B., B.M.); UNC Lineberger Comprehensive Cancer Center, Chapel Hill (W.Y.K.), and Duke University Medical Center and Duke Cancer Institute, Durham (J.H., S.H.) — both in North Carolina; the University of Kansas Cancer Center, Westwood (R.P.); Memorial Sloan Kettering Cancer Center, New York (M.Y.T., M.J.M., J.E.R.), and Roswell Park Comprehensive Cancer Center, Buffalo (G.C.) — both in...
Marijo Bilusic
University of Miami/Sylvester Comprehensive Cancer Center, Miami, FL
Catherine Handy Marshall
Johns Hopkins University School of Medicine, Baltimore, MD
Katherine Lee-Wisdom
Deborah Jolissaint
Walter Reed National Military Medical Center, Bethesda, MD
Gregory T. Chestnut
The Center for Prostate Disease Research/Walter Reed, Bethesda, MD
William Douglas Figg
Fatima Karzai
Peter Choyke
2Molecular Imaging Branch, NCI, Center for Cancer Research, NIH, Bethesda, United States
Melissa Lauren Abel
Genitourinary Malignancies Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD