This single-arm phase 2 trial investigates whether a single high-dose radiotherapy treatment can safely treat men whose prostate cancer has come back in a small number of lymph nodes in the pelvis or abdomen after curative treatment. Participants receive one fraction of 24 Gy delivered with MR-guided stereotactic body radiotherapy (SBRT), which uses MRI to visualise the tumour and surrounding organs during treatment. The main goal is to assess safety (severe side effects). The trial also evaluates local tumour control, longer-term side effects, time until hormone (androgen deprivation) therapy is needed, survival, and quality of life. The trial aims to enrol 48 patients.
Age ≥ 18 years
Signed informed consent
Histologically proven initial diagnosis of adenocarcinoma of the prostate
ECOG performance status 0-2
Medical contraindications to MRI
Inability to tolerate the physical set-up required for SABR
Overlap between prior radiation fields and the current target area leading to high risk of clinically significant normal-tissue injury
Contraindications to pelvic radiotherapy (chronic pelvic inflammatory bowel disease)
Single group
Single-fraction SBRT
RadiationParticipants will receive 24 Gy in 1 fraction to a lymph node.
Number of Participants with cumulative CTCAE v5.0 grade ≥4 treatment-related adverse events
The NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 measures side-effects. Possible scores range from 0-5, with higher scores indicating a worse outcome.
Number of participants with late adverse events (CTCAE v5.0)
The NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 measures side-effect. Possible scores range from 0-5, with higher scores indicating a worse outcome.
Percentage of participants free from local progression (PSMA-PET/CT-verified), estimated by time-to-event analysis
Defined as freedom from PSMA-verified relapse within the treated area. In the case of significant increase in PSA, a PSMA will be performed as to local guidelines. Local control will be evaluated at a lesion level, lesion by lesion. Within the treated area is defined as within or adjacent to the planning target volume (PTV).
Median clinical progression-free survival
Defined as time from inclusion to any new node or distant metastases recurrence.
Median time to initiation of palliative ADT (ADT-free survival)
ADT-free survival is defined as the time from trial randomization to start of hormonal treatment
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Odense University Hospital
Lead sponsor
Danish Cancer Society
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
