Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.

Summary

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.

Eligibility

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.

Conditions2

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