Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.

Launched by LUND UNIVERSITY HOSPITAL · Apr 23, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treat prostate cancer that has come back after surgery, known as biochemical recurrence. Specifically, the trial is looking at whether adding radiation to the lymph nodes can improve treatment outcomes for men who have a specific level of prostate-specific antigen (PSA) in their blood, which indicates the presence of cancer. Participants in this study will be randomly assigned to either receive this additional radiation or standard treatment, and researchers want to see how this affects their recovery.

To be eligible for the trial, participants need to be men aged 18 or older with a life expectancy of more than 10 years. They should have had surgery for prostate cancer and currently have a PSA level between 0.15 and 0.70 ng/ml. Individuals with certain health conditions, such as active heart disease or previous cancer treatments, may not qualify. If chosen for the trial, participants can expect regular check-ups and tests to monitor their health and the effectiveness of the treatment. This trial is currently recruiting participants, which means they are looking for men who meet the criteria and are interested in taking part.

Gender

MALE

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.