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| Name | Class |
|---|---|
| Dutch Cancer Society | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional | Active Comparator | Conventional sEBRT |
|
| Hypofractionation | Experimental | Hypofractionated sEBRT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional sEBRT | Radiation | A total dose of70 Gy in 35 daily fractions of 2 Gy during 7 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 5-year progression-free survival | Defined as biochemical progression, clinical progression, loco-regional or distant progression or start with hormonal therapy, whichever occurs first | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Acute grade ≥ 2 gastrointestinal toxicity | 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. | Up to 3 months after completion of the RT |
| Acute grade ≥ 2 genitourinary toxicities |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| F. Staal, MD | Contact | 0031655257985 | f.h.e.staal@umcg.nl | |
| P. Veldhuijzen van Zanten | Contact | 0031503614659 | peryton@rt.umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| S. Aluwini, Dr. | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiotherapiegroep | Recruiting | Arnhem | Gelderland | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37729971 | Derived | Staal FHE, Janssen J, Oprea-Lager DE, Engelen AM, van Limbergen EJ, Smeenk RJ, de Jong MAA, Budiharto TCG, Jacobs I, Haverkort DMAD, Brouwer CL, Ng Wei Siang K, Langendijk JA, Verzijlbergen JF, de Jong IJ, Noordzij W, Aluwini S. Prostate-Specific Membrane Antigen Positron Emission Tomography/Computed Tomography-Based Clinical Target Volume Delineation Guideline for Postprostatectomy Salvage Radiation Therapy: The PERYTON Guideline. Int J Radiat Oncol Biol Phys. 2024 Mar 1;118(3):688-696. doi: 10.1016/j.ijrobp.2023.09.016. Epub 2023 Sep 18. | |
| 35428210 |
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2 randomised arms
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no masking
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| Hypofractionated sEBRT | Radiation | A total dose of 60 Gy in 20 daily fractions of 3 Gy during 4 weeks |
|
|
As assessed using physician-reported score using questionnaires (CTCAE 5.0 toxicity score). |
| Up to 3 months after completion of the RT |
| Late grade ≥ 2 gastrointestinal toxicity | As assessed using physician-reported score (CTCAE 5.0 toxicity score). | Up to 5 years after completion of the RT |
| Late grade ≥ 2 genitourinary toxicity | Using physician-reported score (CTCAE 5.0 toxicity score). | Up to 5 years after completion of the RT |
| Quality of life after radiation | As assessed using patient-reported questionnaires: measurend with European platform of cancer research-QLQ C30 | Up to 5 years after completion of the RT |
| Metastasis-free survival | Time from randomisation to the date of metastases reported by CT scan, MRI scan or PSMA-PET/CT during the follow up (date scan). | 5 years |
| Prostate cancer-specific mortality | Prostate cancer-specific mortality. | 5 years |
| Overall survival | Overall survival | 5 years |
| Acute grade ≥ 2 gastrointestinal toxicity | Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4). | Up to 3 months after completion of the RT |
| Acute grade ≥ 2 genitourinary toxicities | Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4). | Up to 3 months after completion of the RT |
| Late grade ≥ 2 genitourinary toxicity | Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4). | Up to 5 years after completion of the RT |
| Quality of life after radiation | As assessed using patient reported quatinnaires: European platform of cancer research-Quality of Life Questionnaire - Prostate Cancer Module (PR 25). | Up to 5 years after completion of the RT |
| Radboud University Medical Center | Recruiting | Nijmegen | Gelderland | Netherlands |
|
| Maastro Clinic | Recruiting | Maastricht | Limburg | Netherlands |
|
| Catharina-Hospital | Recruiting | Eindhoven | North Brabant | Netherlands |
|
| Verbeeten Institute | Recruiting | Tilburg | North Brabant | Netherlands |
|
| Amsterdam UMC (Location VUmc) | Not yet recruiting | Amsterdam | North Holland | Netherlands |
|
| Radiotherapiegroep | Recruiting | Deventer | Overijssel | Netherlands |
|
| Radiotherapy Institute Friesland | Recruiting | Leeuwarden | Provincie Friesland | Netherlands |
|
| Leiden University Medical Center | Not yet recruiting | Leiden | South Holland | Netherlands |
|
| Erasmus Medical Center | Not yet recruiting | Rotterdam | South Holland | Netherlands |
|
| Haga Hospital | Not yet recruiting | The Hague | South Holland | Netherlands |
|
| Zuidwest Radiotherapeutisch Instituut (ZRTI) | Recruiting | Flushing | Netherlands |
|
| UMCG | Recruiting | Groningen | 9713GZ | Netherlands |
|
| Derived |
| 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. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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