Artificial Intelligence to Personalize Prostate Cancer Treatment (the HypoElect Trial)

NCT06582446 | Recruiting Phase 2

• 2 other identifiers: 2024-PRC-015U1111-1310-7485
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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) whole-pelvis UHF-RT (5 fractions).

Conditions

Prostate Cancer

Keywords

prostate cancer; multimodal AI; radiotherapy; phase II

Outcome Measures

Primary Outcomes (1)

• cumulative GU toxicity

  Primary endpoint is cumulative GU toxicity according to RTOG grading after minimum FU time of two years.

  two years

Secondary Outcomes (22)

• Time to local or regional failure

  two and five years after RT

• MMAI classifier

  5-year and 10-year risk prediction of distant metastasis and 10-year risk of prostate-specific mortality.

• 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

• Metastatic free survival (MFS)

  two and five years after RT

• Overall Survival (OS)

  1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months after RT

Study Arms (1)

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

Drug: Androgen Deprivation Therapy (ADT) - Goserelin; Radiation: High-Dose-Rate Interstitial Brachytherapy (HDR BRT); Radiation: radiotherapy

Interventions

Androgen Deprivation Therapy (ADT) - Goserelin DRUG

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

Single experimental arm

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.)

Single experimental arm

radiotherapy RADIATION

EBRT prostate + elective pelvis (Ultra-hypofractionated): 25 Gy in 5 Gy per fraction

Single experimental arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males with prostate cancer. Eligibility is based on histologically confirmed adenocarcinoma of the prostate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• MMAI high-risk
• ECOG Performance score 0 or 1
• IPSS Score ≤15

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• German Oncology Center, Cyprus: lead

Study Sites (1)

German Oncology Center

Limassol, 4108, Cyprus

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists; Goserelin; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Therapeutics

Study Officials

• Iosif Strouthos, MD

  German Medical Institute

  PRINCIPAL INVESTIGATOR

• Constantinos Zamboglou, MD

  German Medical Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Pallari, PhD

CONTACT

0035725028690; elena.pallari@goc.com.cy

Kristis Vevis, PhD

CONTACT

0035725208159; kristis.vevis@goc.com.cy

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: September 3, 2024
• Study Start: September 16, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)