PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy (PERYTON)
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ClinicalTrials.gov Identifier: NCT04642027 |
Recruitment Status :
Recruiting
First Posted : November 24, 2020
Last Update Posted : February 28, 2024
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer Cancer Recurrence | Radiation: Conventional sEBRT Radiation: Hypofractionated sEBRT | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 538 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 2 randomised arms |
Masking: | None (Open Label) |
Masking Description: | no masking |
Primary Purpose: | Treatment |
Official Title: | PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy of Biochemical Failure After Radical Prostatectomy for Prostate Cancer |
Actual Study Start Date : | September 1, 2020 |
Estimated Primary Completion Date : | September 1, 2029 |
Estimated Study Completion Date : | September 1, 2030 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Conventional
Conventional sEBRT
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Radiation: Conventional sEBRT
A total dose of70 Gy in 35 daily fractions of 2 Gy during 7 weeks
Other Name: Conventional salvage external beam radiation therapy |
Experimental: Hypofractionation
Hypofractionated sEBRT
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Radiation: Hypofractionated sEBRT
A total dose of 60 Gy in 20 daily fractions of 3 Gy during 4 weeks
Other Name: Hypofractionated salvage external beam radiation therapy |
- 5-year progression-free survival [ Time Frame: 5 years ]Defined as biochemical progression, clinical progression, loco-regional or distant progression or start with hormonal therapy, whichever occurs first
- Acute grade ≥ 2 gastrointestinal toxicity [ Time Frame: Up to 3 months after completion of the RT ]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.
- Acute grade ≥ 2 genitourinary toxicities [ Time Frame: Up to 3 months after completion of the RT ]As assessed using physician-reported score using questionnaires (CTCAE 5.0 toxicity score).
- Late grade ≥ 2 gastrointestinal toxicity [ Time Frame: Up to 5 years after completion of the RT ]As assessed using physician-reported score (CTCAE 5.0 toxicity score).
- Late grade ≥ 2 genitourinary toxicity [ Time Frame: Up to 5 years after completion of the RT ]Using physician-reported score (CTCAE 5.0 toxicity score).
- Quality of life after radiation [ Time Frame: Up to 5 years after completion of the RT ]As assessed using patient-reported questionnaires: measurend with European platform of cancer research-QLQ C30
- Metastasis-free survival [ Time Frame: 5 years ]Time from randomisation to the date of metastases reported by CT scan, MRI scan or PSMA-PET/CT during the follow up (date scan).
- Prostate cancer-specific mortality [ Time Frame: 5 years ]Prostate cancer-specific mortality.
- Overall survival [ Time Frame: 5 years ]Overall survival
- Acute grade ≥ 2 gastrointestinal toxicity [ Time Frame: Up to 3 months after completion of the RT ]Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4).
- Acute grade ≥ 2 genitourinary toxicities [ Time Frame: Up to 3 months after completion of the RT ]Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4).
- Late grade ≥ 2 genitourinary toxicity [ Time Frame: Up to 5 years after completion of the RT ]Using patient-reported questionnaires (Radiation Therapy Oncology Group (RTOG) / European platform of cancer research (EORTC) toxicity questionnaires with grade 1 to 4).
- Quality of life after radiation [ Time Frame: Up to 5 years after completion of the RT ]As assessed using patient reported quatinnaires: European platform of cancer research-Quality of Life Questionnaire - Prostate Cancer Module (PR 25).
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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 (< 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:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04642027
Contact: F. Staal, MD | 0031655257985 | f.h.e.staal@umcg.nl | |
Contact: P. Veldhuijzen van Zanten | 0031503614659 | peryton@rt.umcg.nl |
Netherlands | |
Radiotherapy Institute Friesland | Recruiting |
Leeuwarden, Friesland, Netherlands | |
Contact: M. De Jong, MD | |
Radiotherapiegroep | Recruiting |
Arnhem, Gelderland, Netherlands | |
Contact: D. Haverkort, MD | |
Radboud University Medical Center | Recruiting |
Nijmegen, Gelderland, Netherlands | |
Contact: R.J. Smeenk, MD, PhD | |
Maastro Clinic | Recruiting |
Maastricht, Limburg, Netherlands | |
Contact: B. Vanneste, MD | |
Catharina-Hospital | Recruiting |
Eindhoven, Noord Brabant, Netherlands | |
Contact: T.C.G. Budiharto, MD, PhD | |
Verbeeten Institute | Recruiting |
Tilburg, Noord-Brabant, Netherlands | |
Contact: M.A.E. van de Sande, MD | |
Amsterdam UMC (Location VUmc) | Not yet recruiting |
Amsterdam, Noord-Holland, Netherlands | |
Contact: J. van Moorselaar, Professor | |
Radiotherapiegroep | Recruiting |
Deventer, Overijssel, Netherlands | |
Contact: D. Haverkort, MD | |
Haga Hospital | Not yet recruiting |
Den Haag, Zuid-Holland, Netherlands | |
Contact: B. Hollman, MD | |
Leiden University Medical Center | Not yet recruiting |
Leiden, Zuid-Holland, Netherlands | |
Contact: S. Rademakers, MD, PhD | |
Erasmus Medical Center | Not yet recruiting |
Rotterdam, Zuid-Holland, Netherlands | |
Contact: L. Incocci, Professor | |
UMCG | Recruiting |
Groningen, Netherlands, 9713GZ | |
Contact: F.H.E. Staal, MD. PERYTON@rt.umcg.nl | |
Zuidwest Radiotherapeutisch Instituut (ZRTI) | Recruiting |
Vlissingen, Netherlands | |
Contact: Inge Jacobs i.jacobs@zrti.nl |
Principal Investigator: | S. Aluwini, Dr. | UMCG |
Responsible Party: | University Medical Center Groningen |
ClinicalTrials.gov Identifier: | NCT04642027 |
Other Study ID Numbers: |
RT2020-01 |
First Posted: | November 24, 2020 Key Record Dates |
Last Update Posted: | February 28, 2024 |
Last Verified: | February 2024 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
PSMA-PET/CT Salvage Hypofractionation Radiotherapy Prostatectomy |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Recurrence |
Genital Diseases, Male Genital Diseases Urogenital Diseases Male Urogenital Diseases Disease Attributes Pathologic Processes |