Prostate CancerPhase 2HypoElectNCT06582446
Artificial Intelligence to Personalize Prostate Cancer Treatment (the HypoElect Trial)
A Phase 2 study testing Androgen Deprivation Therapy (ADT) - Goserelin, High-Dose-Rate Interstitial Brachytherapy (HDR BRT) and radiotherapy in people with Prostate Cancer, run by German Oncology Center, Cyprus at 1 site in Cyprus.
Trial summary
A prospective, single-arm phase II study is the individualization of RT for patients with high-risk localized PCa based on multimodal artificial intelligence (MMAI). All patients will receive the current standard of care: (i) a dose escalation to the prostate via HDR brachytherapy, (ii) two years of ADT and (iii)… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Androgen Deprivation Therapy (ADT) - Goserelin, High-Dose-Rate Interstitial Brachytherapy (HDR BRT) and radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCyprus
- Study dates
- 16 Sep 2024to 31 Aug 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate (histological confirmation can be based on tissue taken at any time, but a re-biopsy should be considered if the biopsy is more than 12 months old)
- Primary PCa (in PSMA-PET imaging and multiparametric magnetic resonance imaging (mpMRI)
- High- or very high-risk according to NCCNv1.2023 criteria
- Signed written informed consent for this study
- Age >18 years
- Previously conducted PSMA-PET/CT, mpMRI or PSMA-PET/MR
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- MMAI high-risk
- ECOG Performance score 0 or 1
- IPSS Score ≤15
Who cannot join
- Prior radiotherapy to the prostate or pelvis
- Prior radical prostatectomy
- Prior focal therapy approaches to the prostate
- Evidence of pelvic nodal disease (cN+) in mpMRI and/or PSMA-PET/CT
- Evidence of distant metastatic disease (cM+) in mpMRI and/or PSMA-PET/CT
- Time gap between the beginning of any systemic therapyADT and conduction of PSMA-PET scans is >2 months
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- Evidence of cT4 disease in mpMRI and/or PSMA-PET/CT
- PSA >50 ng/ml prior to starting of systemic therapy
- Expected patient survival <5 years
- Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artifacts
- Contraindication to undergo a MRI scan
- Contraindication to undergo HDR brachytherapy (brachytherapy not feasible due to large prostate volume, prostate anatomy, tumor in distant seminal vesicles and/or unfit for anesthesia)
- Prostate surgery (TURP or HOLEP) with a significant tissue cavity or prostate surgery (TURP or HOLEP) within the last 6 months prior to randomization
- Medical conditions likely to make radiotherapy inadvisable e.g. acute inflammatory bowel disease, hemiplegia or paraplegia
- Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin), or if previous malignancy is expected to significantly compromise 5 year survival
- Any other contraindication to external beam radiotherapy (EBRT) to the pelvis
- Participation in any other interventional clinical trial within the last 30 days before the start of this trial
- Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
- Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial
- Known or persistent abuse of medication, drugs or alcohol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cyprus1 site, 1 recruiting
- Recruiting
German Oncology Center
Limassol, 4108
Elena Pallari, PhD, +35725208690, elena.pallari@goc.com.cy
Kristis Vevis, PhD, +35725208159, kristis.vevis@goc.com.cy
About this study
Official title: Whole-pelvis Hypofractionated Radiotherapy Combined With Dose-escalation to the Prostate and Androgen Deprivation Therapy in Primary Localized, NCCN and MMAI High-risk Prostate Cancer - a Prospective, Single-arm, Phase II Study
A prospective, single-arm phase II study is the individualization of RT for patients with high-risk localized PCa based on multimodal artificial intelligence (MMAI). All patients will receive the current standard of care: (i) a dose escalation to the prostate via HDR brachytherapy, (ii) two years of ADT and (iii) whole-pelvis UHF-RT (5 fractions).
Read the detailed description
Prostate cancer (PCa) is the most frequent diagnosed malignancy in male patients in Europe and radiation therapy (RT) is a main treatment option. For primary high-risk localized PCa patients, NCCNv4.2023 guidelines recommend normo- or hypofractionated RT to the prostate ± the elective pelvic lymphatics and systemic treatment in terms of ADT. Although the standard of care, the benefit of this therapy regimen is controversially discussed: the benefit of (i) an RT dose escalation using brachytherapy (2) or focal dose escalated RT(3) or (ii) an elective RT of the pelvic lymph nodes (1) is not finally proven yet. In parallel, first studies proposed a reduction in treatment fractions in terms of ultra-hypofractionated RT (UHF-RT) (4).
The aim of this prospective, single-arm phase II study is the individualization of RT for patients with high-risk localized PCa based on MMAI. All patients will receive the current standard of care: (i) a dose escalation to the prostate via HDR brachytherapy, (ii) two years of ADT and (iii) whole-pelvis UHF-RT (5 fractions).
For the HypoElect patients we expect no significant differences in toxicity rates compared to the randomized controlled POP-RT trial (1) which treated the patients with moderately-hypofractionated RT to the prostate and the elective pelvic lymph nodes in parallel to 24 months of ADT. Secondary endpoints like relapse free survival, metastatic free survival, prostate cancer survival and overall survival will depict the oncologic efficacy in this patient cohort. Thus, the safety and oncologic outcome results of this study might be the first in this highly selected treatment group: NCCN high-risk, PSMA PET cN0/cM0 and MMAI high-risk. Considering the epidemiological importance of the PCa these results could have a significant socio-economic impact. In parallel a translational research program will address the identification of novel biomarkers to predict the treatment outcome.
- Conditions
- Prostate Cancer
- Being tested
- Androgen Deprivation Therapy (ADT) - Goserelin, High-Dose-Rate Interstitial Brachytherapy (HDR BRT), radiotherapy
- Keywords
- prostate cancer, multimodal AI, radiotherapy, phase II
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Androgen Deprivation Therapy (ADT) - GoserelinDrug
The patients under ADT and the patients who will receive the ADT during the study will be included in the trial.
- ADT will be applied for 24 months in total
- ADT must be given concurrently and adjuvant
High-Dose-Rate Interstitial Brachytherapy (HDR BRT)Radiation
HDR BRT Procedure will be performed using transperineal catheter implantation under transrectal US-guidance performed under anesthesia, spinal or general with patient in high lithotomy position.)
radiotherapyRadiation
EBRT prostate + elective pelvis (Ultra-hypofractionated): 25 Gy in 5 Gy per fraction
| Study group | Role | What they receive |
|---|---|---|
| Single experimental arm | Experimental | RT prostate (HDR brachytherapy): 15 Gy (D90) in 1 fraction HDR RT prostate
EBRT elective pelvis (Ultra-hypofractionated RT - UHF): 25 Gy in 5 Gy per fraction
Technique: IMRT/IGRT/HDR brachytherapy
Duration: 6 fractions, 3 weeks
Androgen deprivation therapy (ADT) - Goserelin: all patients receive ADT; luteinising-hormone-releasing hormone agonists or antagonists for 24 months
Follow-up (FU) per patient: minimum FU time is 5 years (60 months), the study ends when the last enrolled patients reaches 60 months of FU time
Further FU: by the end of this clinical trial it will be decided whether further FU is necessary, amendment to this clinical trial protocol will be done in appropriate time Receives: Drug: Androgen Deprivation Therapy (ADT) - Goserelin; Radiation: High-Dose-Rate Interstitial Brachytherapy (HDR BRT); Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative GU toxicity
Primary endpoint is cumulative GU toxicity according to RTOG grading after minimum FU time of two years.
Measured: two years
Secondary outcomes (22)
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.
Measured: 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)
Measured: 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
Measured: 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)
Measured: two and five years after RT
Overall Survival (OS)
OS after end of RT
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: during, 1 and 3 months after RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start16 Sep 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Oncology Center, Cyprus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iosif Strouthos, MD, Principal investigator, German Medical InstituteConstantinos Zamboglou, MD, Principal investigator, German Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582446
- Sponsor's protocol ID
- 2024-PRC-015
- Other IDs
- U1111-1310-7485
- Acronym
- HypoElect
- Status last verified
- Sep 2026
- First submitted
- 31 Jul 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zamboglou C, Doncker W, Christoforou AT, Arcangeli S, Berlin A, Blanchard P, Bauman G, Campi R, Castro E, Choudhury A, Pra AD, Draulans C, Desai N, Ferentinos K, Francolini G, Gillessen S, Grosu AL, Rivas JG, Hoelscher T, Hruby G, Jereczek-Fossa BA, Kamran S, Kasivisvanathan V, Kishan AU, Kounnis V, Loblaw A, Martin J, Mastroleo F, Merseburger AS, Miszczyk M, Mohamad O, Ost P, Papatsoris A, Peeken JC, Sanguedolce F, Sargos P, Schmidt-Hegemann N, Seibert TM, Shelan M, Siva S, Soeterik TFW, Spratt DE, Stenzl A, Strouthos I, Sutera P, Supiot S, Tilki D, Tran PT, Tree AC, Tward J, Urun Y, Vapiwala N, Waddle MR, Wegener E, Zilli T, Murthy V, Thieme AH, Spohn S. oDigital pathology biomarkers for guiding radiotherapy-based treatment concepts in prostate cancer - a systematic review and expert consensus. Radiother Oncol. 2025 Sep;210:111039. doi: 10.1016/j.radonc.2025.111039. Epub 2025 Jul 9.
PubMed 40645505