Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy

Launched by ASAN MEDICAL CENTER · Apr 17, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at two different types of radiation therapy for men who have experienced a biochemical recurrence of prostate cancer after having their prostate surgically removed. In simple terms, a biochemical recurrence means that a blood test shows an increase in a substance called PSA (prostate-specific antigen), which can indicate that cancer might still be present. The trial compares a new treatment called hypofractionated, accelerated radiation therapy, which delivers a higher dose of radiation in fewer sessions, to the standard radiation treatment, which typically requires more sessions. The goal is to see if the new method works better in controlling the cancer while also looking at any side effects and how it affects patients' quality of life.

To be eligible for this trial, participants need to have been diagnosed with intermediate- or high-risk prostate cancer and must show signs of biochemical recurrence through elevated PSA levels. They should also be in generally good health, with certain acceptable blood test results. However, those with visible tumors, distant spread of cancer, or previous pelvic radiation treatments cannot participate. If someone joins this study, they can expect to receive either the new or standard radiation treatment and will be monitored for both the effectiveness of the therapy and any side effects they may experience during and after the treatment.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Pathologically confirmed intermediate- or high-risk prostate cancer
• • Biochemical recurrence after radical prostatectomy (Definition: Serial elevation of PSA over 0.2 ng/mL and \<=1.0 ng/mL)
• • ECOG performance status 0-1
• • Appropriate values of blood tests within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 Platelets ≥ 50,000 cells/mm3 Hemoglobin ≥ 8.0 g/dl
• • Appropriate values of kidney function within 6 months after enrollment Creatinine \< 2.0 ng/dL
• • Appropriate values of liver function within 6 months after enrollment total bilirubin \< 1.5 X maximum normal value alanine aminotransferase or aspartate aminotransferase \< 2.5 X maximum normal value
• Exclusion Criteria:
• • Clinically gross recurrent tumor
• • Presence of distant metastasis
• • Presence of pelvic LN metastasis
• • History of pelvic irradiation
• • History of cryotherapy or brachytherapy for prostate cancer
• • Double primary cancer other than skin/thyroid cancer
• • Combined serious morbidity