A randomized phase III trial to study the effect of adding lymph node irradiation in patients with poor prostate-specific antigen (PSA) response during salvage radiotherapy for biochemical recurrence (0.15 ≤ PSA \<0.70 ng/ml) after prostatectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
374
Radiation to the prostate bed with or without addition of radiation of lymph node irradiation (non responders). Patients with PSA response continues radiotherapy as initially planned, and are not followed according to the study protocol, only according to clinical practice.
Jönköping County Hospital, Ryhov
Jönköping, Sweden
RECRUITINGKalmar County Hospital
Kalmar, Sweden
RECRUITINGLund University Hospital
Lund, Sweden
RECRUITINGFailure-free survival (FFS).
Failure-free survival after salvage radiotherapy (SRT), with failure defined as either biochemical, defined as verified PSA level of ≥ 0.2 ng/ml above the post-radiotherapy PSA nadir value or clinical Recurrence, imaging or biopsy confirmed.
Time frame: FFS after SRT, with failure defined as either biochemical or clinical recurrence (imaging or biopsy confirmed). FFS is calculated from the randomization date (arms A and B) until end of follow up (month 60 after
Systemic treatment-free survival.
Arms A and B will be compared regarding systemic treatment-free survival.
Time frame: Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).
Distant metastasis-free survival.
Arms A and B will be compared regarding distant metastasis-free survival. survival.
Time frame: Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).
Prostate cancer specific survival.
Arms A and B will be compared regarding prostate cancer specific survival survival.
Time frame: Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).
Overall survival.
Arms A and B will be compared regarding overall survival.
Time frame: Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).
Numbers of patients with acute toxicity (≤ 3 months after end of salvage radiotherapy).
Toxicity that will be evaluated is presence of cystitis, bladder spasm, incontinence, urinary urgency, urinary retention, nausea, diarrhea, colitis, ileus, bloating, bowel obstruction, bowel perforation, gastrointestinal hemorrhage, rectal mucositis, erectile dysfunction, fatigue, lymphedema, pain, blood toxicity.
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Time frame: Up to 3 months after end of salvage radiotherapy.
Numbers of patients with late toxicity (> 3 months to 5 years after end of salvage radiotherapy).
Toxicity that will be evaluated is presence of cystitis, bladder spasm, incontinence, urinary urgency, urinary retention, nausea, diarrhea, colitis, ileus, bloating, bowel obstruction, bowel perforation, gastrointestinal hemorrhage, rectal mucositis, erectile dysfunction, fatigue, lymphedema, pain, blood toxicity.
Time frame: After 3 months after end of salvage therapy until end of follow up at month 60 after end of salvage therapy.
Patients self-esteem of quality of life.
Arms A and B will be compared regarding quality of life.
Time frame: Quality of life evaluated using questionnaire by the European Organisation for Research and Treatment of Cancer (EORTC), questionnaire is QLQ-C30. Is done at baseline, at end of radiotherapy (43 days in Arm A, 35 days in Arm B), month 12, 24, and 60.
Patients self-esteem of quality of life.
Arms A and B will be compared regarding quality of life.
Time frame: Quality of life evaluated using questionnaire by the European Organisation for Research and Treatment of Cancer (EORTC), questionnaire is QLQ - PR25. Is done at baseline, at end of radiotherapy (43 days in Arm A, 35 days in Arm, month 12, 24, and 60.