This interventional prospective multicenter international study will include 54 patients with regionally metastatic (i.e. cN1 cM0) prostate cancer according to the NCCN criteria.
Patients will be treated with weekly CT or MR-informed online adaptive SBRT of the prostate and elective pelvic lymph nodes with 5 x 5 Gy. A simultaneous integrated boost (SIB) of involved lymph nodes will be performed. In the case of up to 2 dominant intraprostatic lesion (DIL) a SIB of the DIL can be performed (optional). Importantly, coverage of these DIL volumes must be compromised as needed to respect OAR constraints.
This study is classified as risk category A according to ClinO, Art. 61, as stereotactic radiotherapy (SBRT) for regionally metastatic prostate cancer has been extensively evaluated in prospective interventional trials and is considered an established therapeutic modality.
Weekly CT- or MR-guided online adaptive SBRT to the prostate and elective pelvic lymph nodes with 5 × 5 Gy is, however, not yet routinely implemented for this specific patient population.
A diagnostic high field MRI during radiotherapy, e.g. week 3 is optional.
Follow-up is also according to standard of care (except for patient reported outcome measure using QLQ-C30 and QLQ-PR25 and a diagnostic MRI at 9 months after SBRT (optional), and 12 months in the case of an image non-complete response at 9 months (optional).
Regionally metastatic prostate cancer (cN1, any T, Gleason 6-10, any PSA) according to NCCN guidelines consisting of ≤ 5 regional lymph node metastases
Good to moderate performance status (WHO 0-2)
Written informed consent.
A PSMA PET and multiparametric MRI is mandatory according to staging guidelines.
>5 regional lymph nodes
Patients with cT4 disease (tumor is fixed or invades adjacent structures other than seminal vesicles such as external sphincter, rectum, bladder, levator muscles, and/or pelvic wall)
Previous radiotherapy to the pelvis or prostate
Previous radical prostatectomy
Single group
weekly CT or MR online adaptive definitive SBRT
DevicePatients will be treated with weekly CT or MR-informed online adaptive SBRT of the prostate and elective pelvic lymph nodes with 5 x 5 Gy. A simultaneous integrated boost (SIB) of involved lymph nodes will be performed. In the case of up to 2 dominant intraprostatic lesion (DIL) a SIB of the DIL can be performed (optional). Importantly, coverage of these DIL volumes must be compromised as needed to respect OAR constraints.
Feasibility- a successful delivery of CT or MR-informed SBRT per fraction
Feasibility will be assessed by recording whether each fraction of stereotactic body radiation therapy (SBRT), guided by computed tomography (CT) or magnetic resonance (MR) imaging, is successfully delivered according to the planned treatment parameters. Successful delivery is defined as completion of the planned fraction without protocol deviations or technical interruptions. Data will be summarized as the proportion of fractions successfully delivered per patient and overall. Every treatment fraction having passed the point of entry into the adaptive workflow will be analyzed for this endpoint.
Safety - Adverse events
The presence of genitourinary or gastrointestinal toxicity of grade ≥ 3 within 1 year after completion of radiotherapy (according to CTCAE v5.0). Treatment-related discontinuation. and Subgroup analyses will be performed for patients with and without regional lymph node metastases (i.e., cN0 versus cN1).
Biochemical progression-free survival
This will be determined from the start of therapy until the occurrence of PSA recurrence according to the Phoenix criteria i.e. post- therapeutic PSA nadir + 2 ng/ml
Castration-resistant free survival
Castration-resistant free survival defined as cancer progression despite low (castrate) levels of testosterone (\<50 ng/dL). Cancer progression is defined as: * Biochemical progression: ≥2 consecutive PSA rises (at least 1 week apart) * Radiologic progression: appearance of new lesions on imaging
Patients Quality of Life EQ-5D-5L from the European Organisation for Research and Treatment of Cancer
Quality-of-life will be measured using the EQ-5D-5L questionnaire during and after treatment All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Patients Quality of Life QLQ-C30 from the European Organisation for Research and Treatment of Cancer
Quality of life will be measured using the EORTC QLQ-C30 questionnaire. This instrument includes functional scales, symptom scales, and a global health status/quality-of-life scale. All scores are linearly transformed to a 1-4 scale. For functional scales and global health status, higher scores indicate better functioning or quality of life, whereas for symptom scales/items, higher scores indicate greater symptom burden.
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