Personalized radiotherapy for prostate cancer recurrence after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.