Clinical trial · Interventional
Point in Time of Radiotherapy for Patients With Biochemical Recurrent Prostate Carcinoma
Postoperative Prostate Carcinoma Recurrence: Instant Radiotherapy Versus Radiotherapy With Additional Imaging With PSA Value >= 1
- 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)
PSA-recurrence prostate carcinoma is associated with two general problems. 1. Localisation of PSA-recurrence is unconfident. In many cases it's not clear if a local, locoregional oder systemic relapse is available. 2. There is no standard therapy proved by randomised clinical trials. Recommended radiotherapy starting with PSA-value \< 0.5 ng/ml according to german S3 guidelines is based on retrospective data. These difficulties may lead to a therapy potentially not adapted to patients situation of disease.This study aims to randomised examine if an instant radiotherapy of prostate PSA-recurrence (PSA-value between 0.2 - 0.99 ng/ml) or a delayed radiotherapy with additional imaging (PSA value \>= 1 ng/ml) including PET/CT and bone scintigraphy for reliable information about tumor location and expansion is beneficial regarding therapy efficiency, quality of life and social economic aspects.
Conditions
Conditions (2)
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 |
| Recurrence | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Instant Radiotherapy according to guidelines | Radiation | — | UNRESOLVED |
| PET/CT | Device | — | UNRESOLVED |
| Radiotherapy after achievement of PSA marginal value | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- delayed radiotherapy
- description
- PET/CT and Radiotherapy after achievement of PSA marginal value Additive imaging
- interventionNames
- Device: PET/CT
- Radiation: Radiotherapy after achievement of PSA marginal value
- type
- ACTIVE_COMPARATOR
- label
- instant radiotherapy
- description
- Instant Radiotherapy according to guidelines
- interventionNames
- Radiation: Instant Radiotherapy according to guidelines
Primary outcomes (1)
- measure
- Disease-free survival according to PSA-value
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * postoperative, biochemical recurrent prostate carcinoma with PSA value between 0.2 to 0.99 ng/ml * prior irradiation * comprehension of study protocol content and signed informed consent form * minimum age 18 years Exclusion Criteria: * primary therapy of prostate carcinoma * PSA value \>= 1 ng/ml * diagnosed distant metastases before randomisation (osseous or systemic) * performed PET/CT before randomisation * malignant slave tumor * potent men that are not willing or are unable to apply consequent contraception * ongoing drug- and/or alcohol abuse * patients that are not willing or able to cooperate according to protocol * patients in care * patients that are not able to understand German language
References
Publications (0)
Data not yet available