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Compares treatment options for Prostate Cancer
Official title Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy
ClinicalTrials.gov ID: NCT03920033
What this study is testing
- What it's testing
- Patients with a biochemical recurrence after radical prostatectomy for moderate- or high- risk prostate cancer are randomly assigned to hypofractionated, accelerated high dose radiation therapy group (65 Gy, 26 fractions) and a control group of standard treatment group (66 Gy, 33 fractions). The criteria for stratification at randomization include 1) risk groups, 2) androgen deprivation therapy, and 3) PSA before salvage radiation therapy, which affect biochemical recurrence.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older, men only
You may be able to join if
- 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...
- Appropriate values of kidney function within 6 months after enrollment Creatinine \< 2.0 ng/dL
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.