Artificial Intelligence Driven Personalisation of Radiotherapy and Concomitant Androgen Deprivation Therapy for Prostate Cancer Patients (the HypoPro Trial)

NCT06772441 | Recruiting Phase 2

• 3 other identifiers: 2024-PRC-0622024-510707-11-00U1111-1309-9298
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective, single-arm phase II study is the individualization of both radiotherapy (RT) and androgen deprivation therapy (ADT) duration for patients with high-risk localized prostate cancer (PCa) according to the National Comprehensive Cancer Network (NCCN) based on multimodal artificial intelligence (MMAI) classification. All patients will receive (i) a dose escalation to the prostate via HDR brachytherapy (boost), (ii) twelve months of ADT and (iii) extremely hypofractionated RT to the prostate (5 fractions). This way, patients in the HypoPro trial will receive a prostate-only dose escalation and benefit from shortening of the ADT compared with current guideline recommendations.

Conditions

Prostate Cancer

Keywords

artificial intelligence; ADT; radiation therapy; androgen deprivation therapy

Outcome Measures

Primary Outcomes (1)

• Disease-free survival 5 years after treatment

  Disease recurrence is defined as PSA failure according to Phoenix, new lesions on PSMA PET and/or MRI imaging or the beginning of any salvage therapy.

  Five years

Secondary Outcomes (16)

• Time to local or regional failure, after end of RT

  Two and five years after RT

• Metastatic free survival (MFS) after end of RT

  Two and five years after RT

• Overall survival (OS)

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

• Prostate cancer specific survival (PCSS)

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

• Biochemical failure

  Two and five years after RT

Study Arms (1)

Single experimental arm

EXPERIMENTAL

Prostate +/-seminal vesicles base HDR BT with 15 Gy (D90) / 1 fraction followed by SBRT with 25 Gy in 5 Gy / fraction (daily); of the prostate +- seminal vesicles. Concomittant/adjuvant admission of 12 months ADT.

Drug: Androgen deprivation therapy (ADT)

Interventions

Androgen deprivation therapy (ADT) DRUG

* Goserelin: AstraZeneca, 10.8mg injection * ADT will be applied for 12 months in total * ADT must be given concurrently and adjuvant

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-risk according to NCCNv4.2023 criteria (cT3a or Grade group 4-5 or PSA \> 20 ng/ml)
• Signed written informed consent for this study
• Age \>18 years
• Previously conducted PSMA-PET/CT, mpMRI or PSMA-PET/MR
• MMAI low-/intermediate-risk
• ECOG Performance score 0 or 1
• IPSS Score ≤15
• Prostate biopsy core with the highest ISUP grade available

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 therapy, ADT 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 anaesthesia)
• Contraindication to Goserelin
• 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

Sponsors & Collaborators

• German Oncology Center, Cyprus: lead
• Artera: collaborator

Study Sites (1)

German Oncology Center

Limassol, 4108, Cyprus

RECRUITING

Related Publications (5)

• Gorovets D, Hopkins M, Kollmeier M, Moore A, Goel A, Shasha D, Brennan V, McBride S, Cohen G, Damato AL, Zelefsky MJ. Early outcomes of high-dose-rate brachytherapy combined with ultra-hypofractionated radiation in higher-risk prostate cancer. Brachytherapy. 2021 Nov-Dec;20(6):1099-1106. doi: 10.1016/j.brachy.2021.08.006. Epub 2021 Sep 26.

  PMID: 34588146 BACKGROUND

• van As N, Griffin C, Tree A, Patel J, Ostler P, van der Voet H, Loblaw A, Chu W, Ford D, Tolan S, Jain S, Camilleri P, Kancherla K, Frew J, Chan A, Naismith O, Armstrong J, Staffurth J, Martin A, Dayes I, Wells P, Price D, Williamson E, Pugh J, Manning G, Brown S, Burnett S, Hall E. Phase 3 Trial of Stereotactic Body Radiotherapy in Localized Prostate Cancer. N Engl J Med. 2024 Oct 17;391(15):1413-1425. doi: 10.1056/NEJMoa2403365.

  PMID: 39413377 BACKGROUND

• Spratt DE, Tang S, Sun Y, Huang HC, Chen E, Mohamad O, Armstrong AJ, Tward JD, Nguyen PL, Lang JM, Zhang J, Mitani A, Simko JP, DeVries S, van der Wal D, Pinckaers H, Monson JM, Campbell HA, Wallace J, Ferguson MJ, Bahary JP, Schaeffer EM, Sandler HM, Tran PT, Rodgers JP, Esteva A, Yamashita R, Feng FY. Artificial Intelligence Predictive Model for Hormone Therapy Use in Prostate Cancer. NEJM Evid. 2023 Aug;2(8):EVIDoa2300023. doi: 10.1056/EVIDoa2300023. Epub 2023 Jun 29.

  PMID: 38320143 BACKGROUND

• Esteva A, Feng J, van der Wal D, Huang SC, Simko JP, DeVries S, Chen E, Schaeffer EM, Morgan TM, Sun Y, Ghorbani A, Naik N, Nathawani D, Socher R, Michalski JM, Roach M 3rd, Pisansky TM, Monson JM, Naz F, Wallace J, Ferguson MJ, Bahary JP, Zou J, Lungren M, Yeung S, Ross AE; NRG Prostate Cancer AI Consortium; Sandler HM, Tran PT, Spratt DE, Pugh S, Feng FY, Mohamad O. Author Correction: Prostate cancer therapy personalization via multi-modal deep learning on randomized phase III clinical trials. NPJ Digit Med. 2023 Feb 22;6(1):27. doi: 10.1038/s41746-023-00769-z. No abstract available.

  PMID: 36813827 BACKGROUND

• Kerkmeijer LGW, Groen VH, Pos FJ, Haustermans K, Monninkhof EM, Smeenk RJ, Kunze-Busch M, de Boer JCJ, van der Voort van Zijp J, van Vulpen M, Draulans C, van den Bergh L, Isebaert S, van der Heide UA. Focal Boost to the Intraprostatic Tumor in External Beam Radiotherapy for Patients With Localized Prostate Cancer: Results From the FLAME Randomized Phase III Trial. J Clin Oncol. 2021 Mar 1;39(7):787-796. doi: 10.1200/JCO.20.02873. Epub 2021 Jan 20.

  PMID: 33471548 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists

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

Central Study Contacts

Elena Pallari, PhD

CONTACT

+357 25028690; elena.pallari@goc.com.cy

Kristis Vevis, PhD

CONTACT

+357 25208159; 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: January 3, 2025
• First Posted: January 13, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: January 13, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)