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Prostate CancerPhase 2HypoProNCT06772441

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

A Phase 2 study testing Androgen deprivation therapy (ADT) in people with Prostate Cancer, run by German Oncology Center, Cyprus at 1 site in Cyprus.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… 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)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCyprus
Study dates
1 Nov 2024to 31 Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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-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
Show all 10Show fewer
  • MMAI low-/intermediate-risk
  • ECOG Performance score 0 or 1
  • IPSS Score ≤15
  • Prostate biopsy core with the highest ISUP grade available

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 therapy, ADT and conduction of PSMA-PET scans is >2 months
Show all 22Show fewer
  • 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
  • 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
  • Patients expected to have severe set up problems (e.g. mental condition)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Elena Pallari, PhD contact

+357 25028690

elena.pallari@goc.com.cy

Kristis Vevis, PhD contact

+357 25208159

kristis.vevis@goc.com.cy

Cyprus1 site, 1 recruiting

  • German Oncology Center

    Limassol, 4108

    Elena Pallari, PhD, +357 25208690, elena.pallari@goc.com.cy

    Kristis Vevis, PhD, +357 25208159, kristis.vevis@goc.com.cy

    Recruiting

Other trials in Cyprus

About this study

Official title: Prostate-only, Dose-escalated Radiotherapy Plus Concomitant Androgen Deprivation Therapy in Primary Localized, NCCN High Risk and MMAI Classifier Low or Intermediate-risk Prostate Cancer - A Prospective, Single-arm, Phase II Study

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.

Read the detailed description

In Cyprus approximately 800 men are newly diagnosed with PCa every year. Prostate cancer caused 6.1 million disability-adjusted life-years (DALYs) globally in 2016. The socio-economic burden is high since PCa-related life-time costs are approximately 40,000 per patient with early stage disease at initial diagnosis.

This is a prospective, single-center phase II trial. Patient participants will receive treatment for prostate +-seminal vesicles base high-dose-rate brachytherapy (HDR BT) with 15 Gray units (Gy) with minimal dose covering 90% of the prostate (D90) / 1 fraction followed by stereotactic body radiation therapy (SBRT) with 25 Gy in 5 Gy / fraction (daily); of the prostate +- seminal vesicles. Concomittant/adjuvant admission of 12 months ADT.

First: 1 fraction HDR BT including fiducial placement Second: 14 ±2 days gap Third: 5 fractions of SBRT within 5 consecutive weekdays For the HypoPro patients, we expect no significant differences in disease-free survival (DFS) rates compared to the FLAME trial (2) which one arm treated the patients with moderately-hypofractionated RT to the prostate plus dose escalation to the intraprostatic tumor plus 18-24 months of ADT. Secondary endpoints like metastatic free survival, prostate cancer survival and overall survival will depict the oncologic efficacy in this patient cohort. Thus, the results of this study might be used as the basis for a randomized-controlled trial comparing this dose escalated radiotherapy plus shortened ADT duration with the standard of care (no dose escalated RT, ADT for 2-3 years) in this highly selected treatment group: NCCN high-risk, prostate-specific membrane antigen (PSMA) positron emission tomography (PET) cN0/cM0 and MMAI low/intermediate-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)
Keywords
artificial intelligence, ADT, radiation therapy, androgen deprivation therapy
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)Drug

    • Goserelin: AstraZeneca, 10.8mg injection
    • ADT will be applied for 12 months in total
    • ADT must be given concurrently and adjuvant
Study groups in NCT06772441
Study groupRoleWhat they receive
Single experimental armExperimentalProstate +/-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.
Receives: Drug: Androgen deprivation therapy (ADT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Five years

Secondary outcomes (16)

  1. 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, verification via biopsy is warranted

    Measured: Two and five years after RT

  2. Metastatic free survival (MFS) after end of RT

    MFS is defined as survival time in months from beginning of RT until detection of any new lesion confirmed as metastasis by PSMA-PET/CT or mpMR imaging or death.

    Measured: Two and five years after RT

  3. Overall survival (OS)

    OS will be measured from the last day of RT to the date of death whatever the cause of death is. Patients who are alive are censored at the date of the most recent follow-up examination. The cause of death of each patient dying during the study will be recorded and reported.

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

  4. Prostate cancer specific survival (PCSS)

    PCSS is defined from the last day of RT until death as most reasonable consequence of progressive prostate cancer, judged by the investigator.

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

  5. Biochemical failure

    Time to biochemical failure after end of RT (phoenix definition)

    Measured: Two and five years after RT

  6. Quality of Life (QoL)

    Patient-reported outcome measures (PROMs) EPIC-26: the Expanded Prostate Cancer Index-Short form) with score: 0-100

    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)

  7. Quality of Life (QoL)

    Patient-reported outcome measures (PROMs) IIEF-5: The International Index of Erectile Function with score: 0-5

    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)

  8. 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, at 1 and 3 months after RT

  9. 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, at 1 and 3 months after RT

  10. 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: During, at 1 and 3 months after RT

  11. 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: during, 1 and 3 months after RT

  12. 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

  13. 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, at 1 and 3 months after RT

  14. 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: Assessment at 6, 9, 12, 18, and 24 months after RT

  15. GI chronic 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: Assessment at 6, 9, 12, 18, and 24 months after RT

  16. Testosterone recovery

    Testosterone recovery is to be done through a 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2025
  2. Study start1 Nov 2024
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06772441
Sponsor's protocol ID
2024-PRC-062
Other IDs
2024-510707-11-00, U1111-1309-9298
Acronym
HypoPro
Status last verified
Sep 2026
First submitted
3 Jan 2025
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34588146

  • 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.

    PubMed 39413377

  • 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.

    PubMed 38320143

  • 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.

    PubMed 36813827

  • 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.

    PubMed 33471548

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Androgen deprivation therapy (ADT) in people with Prostate Cancer, run by German Oncology Center, Cyprus at 1 site in Cyprus.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elena Pallari, PhD (+357 25028690, elena.pallari@goc.com.cy), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival 5 years after treatment (time frame: Five years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06772441, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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