PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy
- Conditions
- Prostate CancerCancer Recurrence
- Interventions
- Radiation: Conventional sEBRTRadiation: Hypofractionated sEBRT
- Registration Number
- NCT04642027
- Lead Sponsor
- University Medical Center Groningen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 538
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional Conventional sEBRT Conventional sEBRT Hypofractionation Hypofractionated sEBRT Hypofractionated sEBRT
- Primary Outcome Measures
Name Time Method 5-year progression-free survival 5 years Defined as biochemical progression, clinical progression, loco-regional or distant progression or start with hormonal therapy, whichever occurs first
- Secondary Outcome Measures
Name Time Method Acute grade ≥ 2 gastrointestinal toxicity 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).
Quality of life after radiation 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).
Metastasis-free survival 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).
Late grade ≥ 2 genitourinary toxicity 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).
Prostate cancer-specific mortality 5 years Prostate cancer-specific mortality.
Acute grade ≥ 2 genitourinary toxicities 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 gastrointestinal toxicity Up to 5 years after completion of the RT As assessed using physician-reported score (CTCAE 5.0 toxicity score).
Overall survival 5 years Overall survival
Trial Locations
- Locations (12)
Radiotherapy Institute Friesland
🇳🇱Leeuwarden, Friesland, Netherlands
Radiotherapiegroep
🇳🇱Deventer, Overijssel, Netherlands
Radboud University Medical Center
🇳🇱Nijmegen, Gelderland, Netherlands
Maastro Clinic
🇳🇱Maastricht, Limburg, Netherlands
Catharina-Hospital
🇳🇱Eindhoven, Noord Brabant, Netherlands
Verbeeten Institute
🇳🇱Tilburg, Noord-Brabant, Netherlands
Amsterdam UMC (Location VUmc)
🇳🇱Amsterdam, Noord-Holland, Netherlands
Haga Hospital
🇳🇱Den Haag, Zuid-Holland, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Zuid-Holland, Netherlands
Erasmus Medical Center
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Scroll for more (2 remaining)Radiotherapy Institute Friesland🇳🇱Leeuwarden, Friesland, NetherlandsM. De Jong, MDContact