Actively Recruiting
Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.
Led by Lund University Hospital · Updated on 2025-09-16
374
Participants Needed
3
Research Sites
468 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Life expectancy greater than 10 years
- Age 18 years or older
- WHO performance status of 0 or 1
- Histological evidence of prostate cancer in prostatectomy specimen
- Pathologically node-negative primary tumor (pT), no distant metastasis (M0)
- Biochemical recurrence after prostatectomy with PSA between 0.15 and less than 0.70 ng/ml
- Ability to comply with the study protocol
- Signed informed consent
- Adequate lab results: hemoglobin above 90 g/L, neutrophils above 1.0 x 10^9/L, platelets above 75 x 10^9/L, bilirubin below 1.5 times upper limit of normal, ALAT below 5 times upper limit of normal, creatinine below 1.5 times upper limit of normal
You will not qualify if you...
- Presence of regional lymph node or distant metastases diagnosed by imaging
- Prior or ongoing hormonal therapy such as antiandrogens or gonadotropin releasing hormone
- Previous radiotherapy to the pelvis
- Prior malignancy other than prostate cancer or basalioma within the past five years
- Clinically significant active cardiovascular disease, including myocardial infarction within 6 months, unstable angina, or NYHA class III-IV heart failure
- Severe pulmonary disease
- Any other serious or uncontrolled illness that would make participation undesirable according to the investigator
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Jönköping County Hospital, Ryhov
Jönköping, Sweden, 551 85
Actively Recruiting
2
Kalmar County Hospital
Kalmar, Sweden, 391 26
Actively Recruiting
3
Lund University Hospital
Lund, Sweden, 221 85
Actively Recruiting
Research Team
A
Adalsteinn Gunnlaugsson, MD, PhD
CONTACT
J
Jan Sundberg, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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