Prostate cancer
Conditions
Interventions
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 = H
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Patients with prostate adenocarcinoma treated with radical prostatectomy; • Tumour stage pT2-4, R0-1, pN0, or cN0, cNx according to the UICC TNM 2009, only with Gleason score available; • No lymph node or distant metastases. A recent PSMA-PET scan ( 0.1 ng/mL or 3 consecutive rises. The first value must be measured at least 6 weeks after radical prostatectomy; • PSA at inclusion
Exclusion criteria
Exclusion criteria: • Prior pelvic irradiation, (chemo)hormonal therapy or orchiectomy; • Previous or concurrent active invasive cancers other than superficial non-melanoma skin cancers; • Patients with positive nodes or with distant metastases based on the surgical specimen of lymphadenectomy or the following minimum diagnostic workup: PSMA-PET/CT or PSMA-PET/MRI, 60 days prior to registration; • Double-sided metallic hip prosthesis; • Inability or unwillingness to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the 5-year progression-free survival (PFS) after treatment. Progression is defined as biochemical progression, clinical progression, loco-regional or distant progression or start with hormonal therapy, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are: acute and late toxicity, Quality of Life (QoL), PCa-specific mortality, metastasis-free survival and overall survival at 5 years. | — |
Countries
Netherlands
Outcome results
None listed