Personalized radiotherapy for prostate cancer recurrence after surgery
Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy: a Randomized Phase III Study.
This study is testing if adding radiation to the lymph nodes can help men with prostate cancer that has come back after surgery feel better compared to just standard radiation treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 374 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Lund University Hospital Academic / other |
| Locations | 3 sites (Jönköping and 2 other locations) |
| Trial ID | NCT04858880 on ClinicalTrials.gov |
What this trial studies
This phase III trial investigates the effects of adding lymph node irradiation to standard salvage radiotherapy in patients experiencing biochemical recurrence of prostate cancer after prostatectomy. Participants will be randomized to receive radiation to the prostate bed with or without lymph node irradiation, specifically targeting those with a PSA level between 0.15 and 0.70 ng/ml. The study aims to determine if this personalized approach improves outcomes for patients with poor PSA response.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with a life expectancy greater than 10 years and a specific PSA level indicating biochemical recurrence after prostatectomy.
Not a fit: Patients with metastatic disease or those who have received prior pelvic radiotherapy or hormonal therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients with recurrent prostate cancer.
How similar studies have performed: Other studies have explored similar approaches in prostate cancer treatment, showing promising results, but this specific combination of therapies is being tested for the first time.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jönköping and 2 other locations
- Jönköping County Hospital, Ryhov — Jönköping, Sweden (Recruiting)
- Kalmar County Hospital — Kalmar, Sweden (Recruiting)
- Lund University Hospital — Lund, Sweden (Recruiting)
Study contacts
- Study coordinator: Adalsteinn Gunnlaugsson, MD, PhD
- Email: adalsteinn.gunnlaugsson@skane.se
- Phone: +46 46 17 75 20
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.