Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy. (PROPER2)
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, Prostate-Specific Antigen PSA, PSA, Radiation, Lymph node radiation, Prostate cancer recurrence, Randomized trial, Prostatic Neoplasms
Eligibility Criteria
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.
Sites / Locations
- Jönköping County Hospital, RyhovRecruiting
- Kalmar County HospitalRecruiting
- Lund University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
No Intervention
Continued salvage radiotherapy + lymph node irradiation (non responders)
Continued salvage radiotherapy (non responders)
Continued salvage radiotherapy (responders)
Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present) + the addition of lymph node irradiation (46 Gy/23 fractions) given in sequence. Total number of fractions: 35 + 8 = 43 with 15 of the lymph node irradiation fractions delivered concomitant with the prostate bed/local recurrence irradiation. These patients are classified as non responders according to weekly PSA measurements during the first 4 weeks of radiotherapy.
Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present). These patients are classified as non responders according to weekly PSA measurements during the first 4 weeks of radiotherapy.
Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present). These patients are classified as responders according to weekly PSA measurements during the first 4 weeks of radiotherapy, and are not followed according to the study protocol, follow up according to clinical practice.