Trial · NCT06582446
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | cumulative GU toxicity | two years | Primary endpoint is cumulative GU toxicity according to RTOG grading after minimum FU time of two years. |
| Secondary | Time to local or regional failure | two and five years after RT | Time to local or regional failure; after end of RT. Local or regional recurrences have to be confirmed by PSMA-PET or mpMR imaging. For the diagnosis of local failure a verification via biopsy is warranted. |
| Secondary | MMAI classifier | 5-year and 10-year risk prediction of distant metastasis and 10-year risk of prostate-specific mortality. | Prognostic influence of MMAI classifier for outcome; the ArteraAI Prostate Test score (ranging from 0.0 to 1.0) |
| Secondary | Testosterone | assessment at 6,9,12,18 and 24 months after randomization (± 14 days for each visit) and at 30, 36, 42, 48, 54, 60 months after Ultra-hypofractionated RT - UHF (± 1 month | Testosterone recovery is to be done through blood test |
| Secondary | Metastatic free survival (MFS) | two and five years after RT | MFS after end of RT, (all metastases have to be confirmed by PSMA-PET/CT or mpMR imaging) |
| Secondary | Overall Survival (OS) | 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months after RT | OS after end of RT |
| Secondary | Prostate cancer specific survival (PCSS) | 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months after RT | PCSS after end of RT |
| Secondary | Biochemical failure | two and five years after RT | Time to biochemical failure after end of RT (phoenix definition) |
| Secondary | Quality of Life (QoL) | Assessments at 6, 9,12, 18, and 24 months after randomization (± 14 days for each visit) and at 30, 36, 42, 48, 54, 60 months after Ultra-hypofractionated RT - UHF (± 1 month) | Patient-reported outcome measures (PROMs) EPIC-26: the Expanded Prostate Cancer Index-Short form) with score: 0-100 |
| Secondary | QoL | Assessments at 6, 9,12, 18, and 24 months after randomization (± 14 days for each visit) and at 30, 36, 42, 48, 54, 60 months after Ultra-hypofractionated RT - UHF (± 1 month) | Patient-reported outcome measures (PROMs) IIEF-5: The International Index of Erectile Function with score: 0-5 |
| Secondary | QoL | Assessments at 6, 9,12, 18, and 24 months after randomization (± 14 days for each visit) and at 30, 36, 42, 48, 54, 60 months after Ultra-hypofractionated RT - UHF (± 1 month) | Patient-reported outcome measures (PROMs) IPSS: International prostate symptom score with score 0-5 |
| Secondary | Genitourinary (GU) acute toxicities | during, 1 and 3 months after RT | Cumulative acute GU toxicities using the RTOG grading system (Radiation Therapy Oncology Group; with grade: 0-5, where 0 implies no toxicity and 5 implies a side effect related to death) |
| Secondary | GU acute toxicities | during, 1 and 3 months after RT | Cumulative acute GU toxicities using the CTCAE v5.0 criteria (the Common Terminology Criteria for Adverse Events criteria; with grade: 1-5 where 1 means asymptomatic or mild symptoms and 5 means death related to adverse event) |
| Secondary | GU chronic toxicities | 6, 9, 12, 18 and 24 months after RT | Cumulative chronic GU toxicities using the RTOG grading system (Radiation Therapy Oncology Group; with grade: 0-5, where 0 implies no toxicity and 5 implies a side effect related to death) |
| Secondary | GU chronic toxicities | 6, 9, 12, 18 and 24 months after RT | Cumulative chronic GU toxicities using the CTCAE v5.0 criteria (the Common Terminology Criteria for Adverse Events criteria; with grade: 1-5 where 1 means asymptomatic or mild symptoms and 5 means death related to adverse event) |
| Secondary | Gastrointestinal (GI) acute toxicities | during, 1 and 3 months after RT | Cumulative acute GI toxicities using the RTOG grading system (Radiation Therapy Oncology Group; with grade: 0-5, where 0 implies no toxicity and 5 implies a side effect related to death) |
| Secondary | GI acute toxicities | during, 1 and 3 months after RT | Cumulative acute GU toxicities using the CTCAE v5.0 criteria (the Common Terminology Criteria for Adverse Events criteria; with grade: 1-5 where 1 means asymptomatic or mild symptoms and 5 means death related to adverse event) |
| Secondary | GI chronic toxicities | 6, 9, 12, 18 and 24 months after RT | Cumulative chronic GU toxicities using the RTOG grading system (Radiation Therapy Oncology Group; with grade: 0-5, where 0 implies no toxicity and 5 implies a side effect related to death) |
| Secondary | GI chronic toxicities | 6, 9, 12, 18 and 24 months after RT | Cumulative chronic GU toxicities using the CTCAE v5.0 criteria (the Common Terminology Criteria for Adverse Events criteria; with grade: 1-5 where 1 means asymptomatic or mild symptoms and 5 means death related to adverse event) |
| Secondary | Dose contrainsts | during, 1 and 3 months after RT | Feasibility to dose constraints for pelvic lymph nodes irradiation HDR-BT Prostate CTV=PTV Reference dose DR: 15 Gy (100 %) D90 ≥ 100 % V100 ≥ 95 % V150 ≤ 30 % Rectum (OAR) D2cc ≤ 75Gy EQD2(1.5) D1cc ≤ 70% Urethra (OAR) D0.1cc ≤ 115% D10 ≤ 110% D30 ≤ 105Gy EQD2(1.5) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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