PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy
NCT ID: NCT04642027
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
538 participants
INTERVENTIONAL
2020-09-01
2030-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed Recurrence After Radiotherapy in the PSMA PET Scan Era
NCT06508567
PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Patients With Recurrent Prostate Cancer After Prostatectomy
NCT07234981
MRI-guided Brachytherapy and Salvage SBRT Program
NCT07132671
Timing of Post-prostatectomy PSMA Imaging
NCT05008900
PSMA-PET and MRI for Detection of Recurrent Prostate Cancer After Radical Treatment
NCT04298112
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Conventional
Conventional sEBRT
Conventional sEBRT
A total dose of70 Gy in 35 daily fractions of 2 Gy during 7 weeks
Hypofractionation
Hypofractionated sEBRT
Hypofractionated sEBRT
A total dose of 60 Gy in 20 daily fractions of 3 Gy during 4 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Conventional sEBRT
A total dose of70 Gy in 35 daily fractions of 2 Gy during 7 weeks
Hypofractionated sEBRT
A total dose of 60 Gy in 20 daily fractions of 3 Gy during 4 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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.
18 Years
80 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dutch Cancer Society
OTHER
University Medical Center Groningen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
S. Aluwini, Dr.
Role: PRINCIPAL_INVESTIGATOR
UMCG
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Radiotherapiegroep
Arnhem, Gelderland, Netherlands
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands
Maastro Clinic
Maastricht, Limburg, Netherlands
Catharina-Hospital
Eindhoven, North Brabant, Netherlands
Verbeeten Institute
Tilburg, North Brabant, Netherlands
Amsterdam UMC (Location VUmc)
Amsterdam, North Holland, Netherlands
Radiotherapiegroep
Deventer, Overijssel, Netherlands
Radiotherapy Institute Friesland
Leeuwarden, Provincie Friesland, Netherlands
Leiden University Medical Center
Leiden, South Holland, Netherlands
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
Haga Hospital
The Hague, South Holland, Netherlands
Zuidwest Radiotherapeutisch Instituut (ZRTI)
Flushing, , Netherlands
UMCG
Groningen, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
D. Haverkort, MD
Role: primary
R.J. Smeenk, MD, PhD
Role: primary
B. Vanneste, MD
Role: primary
T.C.G. Budiharto, MD, PhD
Role: primary
M.A.E. van de Sande, MD
Role: primary
J. van Moorselaar, Professor
Role: primary
D. Haverkort, MD
Role: primary
M. De Jong, MD
Role: primary
S. Rademakers, MD, PhD
Role: primary
L. Incocci, Professor
Role: primary
B. Hollman, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Staal FHE, Janssen J, Brouwer CL, Langendijk JA, Ng Wei Siang K, Schuit E, de Jong IJ, Verzijlbergen JF, Smeenk RJ, Aluwini S. Phase III randomised controlled trial on PSMA PET/CT guided hypofractionated salvage prostate bed radiotherapy of biochemical failure after radical prostatectomy for prostate cancer (PERYTON-trial): study protocol. BMC Cancer. 2022 Apr 15;22(1):416. doi: 10.1186/s12885-022-09493-5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RT2020-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.