Status:
RECRUITING
Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.
Lead Sponsor:
Lund University Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2030
Estimated Enrollment :
374 Patients enrolled
Trial Details
Trial ID
NCT04858880
Start Date
April 9 2021
End Date
April 1 2030
Last Update
September 16 2025
Active Locations (3)
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1
Jönköping County Hospital, Ryhov
Jönköping, Sweden, 551 85
2
Kalmar County Hospital
Kalmar, Sweden, 391 26
3
Lund University Hospital
Lund, Sweden, 221 85