Clinical trial · Interventional
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.
NCT04858880CI-TRIAL-00095256PROPER2recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation to the prostate bed with or without addition of radiation of lymph node irradiation. | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Continued salvage radiotherapy + lymph node irradiation (non responders)
- description
- Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present) + the addition of lymph node irradiation (46 Gy/23 fractions) given in sequence. Total number of fractions: 35 + 8 = 43 with 15 of the lymph node irradiation fractions delivered concomitant with the prostate bed/local recurrence irradiation. These patients are classified as non responders according to weekly PSA measurements during the first 4 weeks of radiotherapy.
- interventionNames
- Radiation: Radiation to the prostate bed with or without addition of radiation of lymph node irradiation.
- type
- ACTIVE_COMPARATOR
- label
- Continued salvage radiotherapy (non responders)
- description
- Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present). These patients are classified as non responders according to weekly PSA measurements during the first 4 weeks of radiotherapy.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.