Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.

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 Criteria:

• 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 Criteria:

• Metastases (regional lymph nodes or distant)* diagnosed with imaging.
• 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.