Contemporary prostate cancer radiation therapy trials may underestimate the risk of biochemical recurrence Journal Article
| Authors: | West, M.; Flores, J. M.; Mulhall, J. P. |
| Article Title: | Contemporary prostate cancer radiation therapy trials may underestimate the risk of biochemical recurrence |
| Abstract: | Background: Radiotherapy is often given with androgen deprivation therapy for prostate cancer which causes a reduction in testosterone levels, which when below castrate levels, can cause the prostate specific antigen (PSA) levels to be artificially low. Aim: To determine if high-level radiotherapy clinical trials are underestimating biochemical recurrence (BCR) rates due to inadequate measurement of testosterone levels. Methods: The study plans for clinical trials performed by the Radiation Therapy Oncology Group (RTOG [now NRG]) on clinicaltrials.gov were reviewed for details on testosterone measurement in trials from 1994 to 2023, namely if the testosterone levels were indexed to PSA levels. Outcomes: PSA being indexed to testosterone levels and other metrics of testosterone measurement, including time of day of measurement, assay used, and mean testosterone measurement. Results: Five of 21 (24%) trials stipulated that testosterone levels should be indexed to PSA levels. Eleven of 21 (52%) trials made no mention of testosterone. No trial reported testosterone assay or time of day of measurement. Thirteen of 21 (62%) trials did not require regular follow-up testosterone measurements. Clinical Implications: The number of clinical trials indexing or regularly measuring testosterone was surprisingly low, which could cause an underestimation of BCR rates. Strengths and Limitations: Strengths include being the first study, to our knowledge, to analyze the details of testosterone measurement in high-level radiotherapy trials. Limitations include only analyzing RTOG/NRG trials, analyzing unpublished data, and using clinicaltrials.gov rather than official trial protocols to determine details of testosterone measurement. Conclusion: Indexing of testosterone levels to PSA levels in high-level radiotherapy trials using androgen deprivation therapy was uncommon, possibly rendering data on BCR unreliable, potentially underestimating BCR rates. © The Author(s) 2024. Published by Oxford University Press on behalf of The International Society for Sexual Medicine. All rights reserved. |
| Keywords: | intensity modulated radiation therapy; monotherapy; cancer radiotherapy; follow up; prostate specific antigen; prevalence; assay; risk assessment; prostate cancer; gleason score; brachytherapy; radiation therapy; external beam radiotherapy; stereotactic body radiation therapy; energy; androgen deprivation therapy; testosterone; biochemical recurrence; knowledge; disease surveillance; protocol; clinical trial (topic); liquid chromatography-mass spectrometry; procedures; medical procedures; three dimensional conformal radiation therapy; human; male; article; testosterone assay |
| Journal Title: | Journal of Sexual Medicine |
| Volume: | 22 |
| Issue: | 2 |
| ISSN: | 1743-6095 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2025-02-01 |
| Start Page: | 369 |
| End Page: | 372 |
| Language: | English |
| DOI: | 10.1093/jsxmed/qdae191 |
| PUBMED: | 39786493 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- MSK Cancer Center Support Grant (P30 CA008748) acknowledged in PubMed and PDF -- MSK corresponding author is Michael West -- Source: Scopus |
Altmetric
Citation Impact
BMJ Impact Analytics
MSK Authors
Related MSK Work