Artificial Intelligence to Personalize Prostate Cancer Treatment (the HypoElect Trial)
NCT Number: NCT06582446
Acronym: HypoElect
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Prostate Cancer
Interventions: DRUG: Androgen Deprivation Therapy (ADT) - Goserelin|RADIATION: High-Dose-Rate Interstitial Brachytherapy (HDR BRT)
Sponsor: German Oncology Center, Cyprus
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-08-31
Locations: German Oncology Center, Limassol, 4108, Cyprus

Summary:
A prospective, phase II study applying Artificial Intelligence aiming at individualization of Radiotherapy and Androgen Deprivation Therapy duration for patients with Prostate Cancer. All patients will be treated using (i) an increased dose to the prostate (HDR brachytherapy), (ii) twelve months of ADT and (iii) extremely hypofractionated RT to the prostate (5 fractions). This way, patients will receive a prostate-only dose escalation and benefit from shortening of the ADT compared with current guideline recommendations.

Primary Outcome Measures: cumulative GU toxicity, Primary endpoint is cumulative GU toxicity according to RTOG grading after minimum FU time of two years., two years
Secondary Outcome Measures: Time to local or regional failure, 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., two and five years after RT|MMAI classifier, Prognostic influence of MMAI classifier for outcome; the ArteraAI Prostate Test score (ranging from 0.0 to 1.0), 5-year and 10-year risk prediction of distant metastasis and 10-year risk of prostate-specific mortality.|Testosterone, Testosterone recovery is to be done through blood test, 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|Metastatic free survival (MFS), MFS after end of RT, (all metastases have to be confirmed by PSMA-PET/CT or mpMR imaging), two and five years after RT|Overall Survival (OS), OS after end of RT, 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months after RT|Prostate cancer specific survival (PCSS), PCSS after end of RT, 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months after RT|Biochemical failure, Time to biochemical failure after end of RT (phoenix definition), two and five years after RT|Quality of Life (QoL), Patient-reported outcome measures (PROMs) EPIC-26: the Expanded Prostate Cancer Index-Short form) with score: 0-100, 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)|QoL, Patient-reported outcome measures (PROMs) IIEF-5: The International Index of Erectile Function with score: 0-5, 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)|QoL, Patient-reported outcome measures (PROMs) IPSS: International prostate symptom score with score 0-5, 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)|Genitourinary (GU) acute toxicities, 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), during, 1 and 3 months after RT|GU acute toxicities, 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), during, 1 and 3 months after RT|GU chronic toxicities, 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), 6, 9, 12, 18 and 24 months after RT|GU chronic toxicities, 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), 6, 9, 12, 18 and 24 months after RT|Gastrointestinal (GI) acute toxicities, 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), during, 1 and 3 months after RT|GI acute toxicities, 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), during, 1 and 3 months after RT|GI chronic toxicities, 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), 6, 9, 12, 18 and 24 months after RT|GI chronic toxicities, 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), 6, 9, 12, 18 and 24 months after RT|Dose contrainsts, 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), during, 1 and 3 months after RT|Dose contrainsts, Feasibility to dose constraints for pelvic lymph nodes irradiation

Pelvic EBRT PTV, Constraint, Vol cc or % PTV P/SV, V95 ≥, 95 PTV LV, V95 ≥, 95 Dmax LV, max \< 107 Dmax SIB, max \< 107

OAR: Rectum Constraint, Vol cc or % V18Gy \< (%), 50 V20Gy \< (%), 30 D1cc ≤ (Gy), 26

OAR: Sigmoid Constraint, Vol cc or % V18Gy \< (%), 50 V20Gy \< (%), 30 D1cc ≤ (Gy), 26

OAR: Bladder Constraint, Vol cc or % V18Gy \< (%), 50 V20Gy \< (%), 30 D1cc ≤ (Gy), 26

OAR: Femoral Head L Constraint, Vol cc or % D10cc ≤ (Gy), 25

OAR: Femoral Head R Constraint, Vol cc or % D10cc ≤ (Gy), 25

OAR: Bowel Cavity (including sigmoid) Constraint, Vol cc or % V25Gy \< (cc), 40 D1cc ≤ (Gy), 26

OAR: Penile bulb Constraint, Vol cc or % Mean \< (Gy), 20, during, 1 and 3 months after RT|Dose contrainsts, Adherence to dose constraints for pelvic lymph nodes irradiation Interruptions of RT in days along with reasons, during, 1 and 3 months after RT|Dose contrainsts, Adherence to dose constraints for pelvic lymph nodes irradiation Treatment not finished due to set-up problems (YES/NO) and reason, during, 1 and 3 months after RT