Tests lymph node radiation for prostate cancer returning after surgery
Tests adding lymph node radiation in adults with prostate cancer returning after surgery.
Plain-language title generated from the registry record
Registry title: Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.
Key facts
- Where
- Jönköping, Kalmar, and Lund, SwedenSee the 3 sites
Where in Sweden
- Jönköping County Hospital, RyhovJönköping, SwedenTaking people
- Kalmar County HospitalKalmar, SwedenTaking people
- Lund University HospitalLund, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Lund University Hospital
- Trial code
- NCT04858880
- Record updated
- 16 September 2025
- Original description
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.Read full original descriptionShow less
Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy: a Randomized Phase III Study.
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.
Inclusion: Life expectancy > 10 years; Age ≥18 years; World Health Organization (WHO) performance status 0-1; Estimated life expectancy >10 years; Histological evidence of prostate cancer in the prostatectomy specimen; Primary tumor, regional nodes, metastasis (TNM): any primary tumor (pT), pathologically node-negative (pN0), M0; Biochemical Recurrence (BCR) after prostatectomy, with 0.15 ≤ PSA <0.70 ng/ml; Patients must be able to comply with the protocol; Signed informed consent; Adequate laboratory findings (Haemoglobin (Hb) >90g/L, absolute neutrophil count >1.0x109/L, platelets >75x109/l, bilirubin <1.5x upper limit of normal (ULN), alanine aminotransferase (ALAT) <5x ULN and creatinine <1.5 ULN).
Exclusion: Prior or ongoing hormonal therapy (antiandrogens or gonadotropin releasing hormone); Prior radiotherapy to the pelvis; Prior malignancy other than prostate cancer and basalioma in the past five years; Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (≤6 months), unstable angina, New York Heart Association (NYHA) class III-IV congestive heart failure; Severe pulmonary disease; Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial; Metastases (regional lymph nodes or distant)* diagnosed with imaging.