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.
About This Trial
- This study is testing whether adding radiation to nearby lymph nodes improves treatment when prostate cancer shows signs of returning after surgery.
- It is open to adults who have slightly rising PSA blood test levels after having their prostate removed, but whose cancer has not spread to other parts of the body.
- If your PSA levels do not drop as expected during initial radiation, you may be selected to receive additional radiation targeted to your lymph nodes.
- Before joining, you should know that you must be in generally good overall health and cannot have had previous pelvic radiation or hormone therapy.
More Information
- 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.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This study is testing whether adding radiation to nearby lymph nodes improves treatment when prostate cancer shows signs of returning after surgery.
Study Details
- Start Date: April 9, 2021
- Lead Sponsor: Lund University Hospital
Full 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 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.
Treatments
- Radiation: Radiation to the prostate bed with or without addition of radiation of lymph node irradiation.