Shorter Radiation Schedule for Prostate Cancer Returning After Surgery
Compares shorter and standard radiation in men whose prostate cancer returned.
Plain-language title generated from the registry record
Registry title: PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy
Key facts
- Where
- Amsterdam, Arnhem, Deventer, Eindhoven, Flushing, Groningen, Leeuwarden, Leiden, Maastricht, Nijmegen, Rotterdam, The Hague, and Tilburg, NetherlandsSee the 13 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT04642027, who can take part
Where in Netherlands
- Amsterdam UMC location VUmcAmsterdam, NetherlandsNot yet recruiting
- RadiotherapiegroepArnhem, NetherlandsTaking people
- RadiotherapiegroepDeventer, NetherlandsTaking people
- Catharina hospitalEindhoven, NetherlandsTaking people
- Zuidwest Radiotherapeutisch Instituut (ZRTI)Flushing, NetherlandsTaking people
- UMCGGroningen, NetherlandsTaking people
- Radiotherapy Institute FrieslandLeeuwarden, NetherlandsTaking people
- Leiden University Medical CenterLeiden, NetherlandsNot yet recruiting
- Maastro ClinicMaastricht, NetherlandsTaking people
- Radboud University Medical CenterNijmegen, NetherlandsTaking people
- Erasmus Medical CenterRotterdam, NetherlandsNot yet recruiting
- Haga HospitalThe Hague, NetherlandsNot yet recruiting
- Verbeeten InstituteTilburg, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Medical Center Groningen
- Trial code
- NCT04642027
- Record updated
- 28 February 2024
- Original description
After radical prostatectomy approximately 15-40% of men develop a biochemical recurrence (BR) within 5 years.Read full original descriptionShow less
PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy of Biochemical Failure After Radical Prostatectomy 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.
Inclusion: 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 (< 60 days) without evidence of lymph node or distant metastases; PSA progression after prostatectomy defined as two consecutive rises with the final PSA > 0.1 ng/mL or 3 consecutive rises. The first value must be measured at least 6 weeks after radical prostatectomy; PSA at inclusion < 1.0 ng/mL; WHO performance status 0-2 at inclusion; Age at inclusion between 18 and 80 years; Written (signed and dated) informed consent prior to registration.
Exclusion: 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 scan, 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.