NCT04858880Recruiting
Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy.
Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy: a Randomized Phase III Study.
Source: ClinicalTrials.gov · Last updated 16 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 374 (estimated)
- First submitted
- 12 Apr 2021
- Start date
- 9 Apr 2021
- Primary completion date
- 30 Apr 2030
- Lead sponsor
- Lund University Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT04858880
What you commit to
- Study type: Interventional
- Planned participants: 374
- From 9 Apr 2021 to the primary completion date, 30 Apr 2030
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or ongoing hormonal therapy (antiandrogens or gonadotropin releasing hormone).
- Prior radiotherapy to the pelvis.
Other illness
- 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.
Other
- Metastases (regional lymph nodes or distant)\* diagnosed with imaging.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jönköping County Hospital, Ryhov Coordinator of this site? Confirm its status | Jönköping | Sweden | Recruiting |
| Kalmar County Hospital Coordinator of this site? Confirm its status | Kalmar | Sweden | Recruiting |
| Lund University Hospital Coordinator of this site? Confirm its status | Lund | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.