OncoMatch/Clinical Trials/NCT04642027
PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy
Is NCT04642027 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies non-drug interventions for prostate cancer.
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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage PT2, PT3, PT4 (UICC TNM 2009)
Tumour stage pT2-4, R0-1, pN0, or cN0, cNx according to the UICC TNM 2009, only with Gleason score available
Performance status
WHO 0–2
Demographics
Prior therapy
Must have received: radical prostatectomy
Patients with prostate adenocarcinoma treated with radical prostatectomy
Cannot have received: pelvic irradiation
Prior pelvic irradiation
Cannot have received: hormonal therapy
(chemo)hormonal therapy
Cannot have received: orchiectomy
orchiectomy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04642027 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior pelvic irradiation, hormonal therapy, orchiectomy disqualifies patients from enrollment.
What disease stage is eligible?
Stage PT2 or PT3 or PT4 is required.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages