Conventional sEBRT
RadiationA total dose of70 Gy in 35 daily fractions of 2 Gy during 7 weeks
Other names: Conventional salvage external beam radiation therapy
NCT Number: NCT04642027
After radical prostatectomy approximately 15-40% of men develop a biochemical recurrence (BR) within 5 years.
The standard treatment of post-prostatectomy BR is salvage external beam radiation therapy (sEBRT). sEBRT can provide long-term disease control; with 5 year biochemical progression-free survival (bPFS) up to 60% and with most treatment failures in the first 2 years after sEBRT.
The main goal of this project is to investigate whether the oncologic outcome in patients with post-prostatectomy recurrent PCa can be improved, by increasing the biological effective radiation dose using a hypofractionated schedule of 20 x 3 = 60 Gy.
The study is designed as a prospective open phase III randomized multicenter trial. All patients with biochemical recurrence with a PSA < 1.0 ng/ml after radical prostatectomy for prostate cancer without evidence of lymph nodes or distance metastases will be included. PSA progression after prostatectomy defined as two consecutive rises with the final PSA > 0.1 ng/mL or three consecutive rises will be included.
All eligible patients will be randomized to one of the following two treatment arms:
Arm 1 = Conventional sEBRT to apply a total dose of 70 Gy in 35 daily fractions of 2 Gy during 7 weeks.
Arm 2 = Hypofractionated sEBRT to apply a total dose of 60 Gy in 20 fractions of 3 Gy during 4 weeks.
The primary endpoint will be the 5-year progression-free survival (PFS) after treatment.
Interested in participating?
Request Info18 year–80 year
Male
Interventional
Phase 3
Radiotherapiegroep, Arnhem, Gelderland, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A total dose of70 Gy in 35 daily fractions of 2 Gy during 7 weeks
Other names: Conventional salvage external beam radiation therapy
A total dose of 60 Gy in 20 daily fractions of 3 Gy during 4 weeks
Other names: Hypofractionated salvage external beam radiation therapy
Time frame: 5 years
Defined as biochemical progression, clinical progression, loco-regional or distant progression or start with hormonal therapy, whichever occurs first
Time frame: Up to 3 months after completion of the RT
As assessed using physician-reported score: Common Terminology Criteria for adverse events version 5.0 (CTCAE-5) toxicity score with a scale of 1 - 4.
Time frame: Up to 3 months after completion of the RT
As assessed using physician-reported score using questionnaires (CTCAE 5.0 toxicity score).
Time frame: Up to 5 years after completion of the RT
As assessed using physician-reported score (CTCAE 5.0 toxicity score).
Time frame: Up to 5 years after completion of the RT
Using physician-reported score (CTCAE 5.0 toxicity score).
Time frame: Up to 5 years after completion of the RT
As assessed using patient-reported questionnaires: measurend with European platform of cancer research-QLQ C30
Time frame: 5 years
Time from randomisation to the date of metastases reported by CT scan, MRI scan or PSMA-PET/CT during the follow up (date scan).
Time frame: 5 years
Prostate cancer-specific mortality.
Time frame: 5 years
Overall survival
Time frame: Up to 3 months after completion of the RT
Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4).
Time frame: Up to 3 months after completion of the RT
Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4).
Time frame: Up to 5 years after completion of the RT
Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4).
Time frame: Up to 5 years after completion of the RT
As assessed using patient reported quatinnaires: European platform of cancer research-Quality of Life Questionnaire - Prostate Cancer Module (PR 25).
Contact information is provided by the study sponsor or research team.
F. Staal, MD
CONTACT
P. Veldhuijzen van Zanten
CONTACT
University Medical Center Groningen
Other
PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy of Biochemical Failure After Radical Prostatectomy for Prostate Cancer
Acronym: PERYTON
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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