Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.
About this 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.
- Condition
- Prostate Cancer
- Tested
- Radiation to the prostate bed with or without addition of radiation of lymph node irradiation.
- Sponsor
- Lund University Hospital
Who can join
- Age
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
Inclusion 13
- Minimum age: 18 years
- Eligible sex: Male
- Study condition: Prostate Cancer
- 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 7
- 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.
Where
3 sites, 3 recruiting
Jönköping County Hospital, Ryhov
Jönköping, Sweden
Kalmar County Hospital
Kalmar, Sweden
Lund University Hospital
Lund, Sweden
Contact
-
Adalsteinn Gunnlaugsson, MD, PhD
+46 46 17 75 20 adalsteinn.gunnlaugsson@skane.se
-
Jan Sundberg, RN
+46 4617 70 34 jan.sundberg@skane.se
Potential match only. Final eligibility is determined by the study team.