Clinical trial · Observational
Hypoxia-driven Prostate Cancer Genomics (HYPROGEN)
Hypoxia-driven Prostate Cancer Genomics (HYPROGEN) - Illuminating the Genomic Landscape of Hypoxia-driven Early Metastatic Prostate Cancer
NCT05702619CI-TRIAL-00063502HYPROGENunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Due to the rapid growth, tumour demand for oxygen is often higher than what can be delivered by the newly forming blood vessels. Tumour adaption to this imbalanced oxygen supply and demand (hypoxia) is associated with poor prognosis and genetic changes (genomic instability) that allow it to become more resistant to chemo- and radiotherapy. Patients with hypoxic tumours therefore die earlier. Limited information is available on hypoxia in newly diagnosed prostate cancer, especially to what degree hypoxia in the prostate tumour is associated with the presence of metastases to bones. The Hyprogen trial is a prospective, non-randomised, exploratory biopsy and imaging biomarker study recruiting 60 patients with prostate cancer to better establish the role of hypoxia in prostate cancer cells evolution and early metastatic spread.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypoxia | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Baseline bloods for CTCs and ct DNA taken at same time as baseline bloods in Arm 1 | Other | — | UNRESOLVED |
| Baseline bloods - for germline testing | Other | — | UNRESOLVED |
| CT-guided Bone Biopsy | Diagnostic Test | — | UNRESOLVED |
| Optional non-IMP pimonidazole | Drug | — | UNRESOLVED |
| Post-pimonidazole bloods for CTCs and ctDNA | Other | — | UNRESOLVED |
| Prostate MRI scans | Diagnostic Test | — | UNRESOLVED |
| Radical Prostatectomy | Procedure | — | UNRESOLVED |
| TRUS-guided Targeted Transperineal Prostate Biopsy | Diagnostic Test |
Design
Arms and outcomes
Arms (2)
- label
- Arm 1
- description
- Arm 1 - De novo, treatment-naïve metastatic prostate cancer
- interventionNames
- Drug: Optional non-IMP pimonidazole
- Diagnostic Test: CT-guided Bone Biopsy
- Diagnostic Test: TRUS-guided Targeted Transperineal Prostate Biopsy
- Diagnostic Test: Whole-body MRI
- Other: Baseline bloods - for germline testing
- Other: Baseline bloods for CTCs and ct DNA taken at same time as baseline bloods in Arm 1
- Other: Post-pimonidazole bloods for CTCs and ctDNA
- label
- Arm 2
- description
- Arm 2 - De novo, treatment- naïve localised prostate cancer planned for radical prostatectomy
- interventionNames
- Drug: Optional non-IMP pimonidazole
- Procedure: Radical Prostatectomy
- Diagnostic Test: Prostate MRI scans
- Other: Baseline bloods - for germline testing
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
ARM 1 Inclusion Criteria: * Male patients aged 18 years and older * Histologically proven adenocarcinoma of the prostate (≥cT2) or Highly suspected metastatic prostate cancer * PSA value of ≥ 20 ng/mL * Multiple lesions (≥ 5) suspicious of metastatic spread on routine imaging procedures with at least one amenable\* to biopsy (cohort A) or oligometastatic bone disease (≥1 to ≤ 4) at routine bone scan with at least one lesion amenable\* to biopsy (cohort B) \*e.g. safely to biopsy and expectably providing sufficient tissue yield World Health Organisation (WHO) performance status 0 to 2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 months * No prior local and/or systemic treatment for localised prostate cancer * Willing to donate cancer tissue samples for research purposes (bone metastasis and primary tumour) Exclusion Criteria: * Involvement in the planning and/or conduct of the study (applies to staff at the study site) * Previous enrolment in the HYPROGEN study * As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. uncompensated respiratory, cardiac, hepatic or renal disease) * Evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study * Any investigational agents or study drugs from a previous clinical study within 30 days of the first tissue collection * Prior treatment of localized prostate cancer including radiotherapy and/or androgen-deprivation therapy * Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements * Contra-indications to MRI (incl. pacemakers etc.) * Bone metastases in difficult to reach areas or areas which might be at risk for pathological fracture post biopsy as judged by biopsying radiologist / chief investigator * Increased risk of bleeding as a result of biopsy * History of bleeding disorders or thrombocytopenia (platelets \<100/nL) * Concomitant treatment with anticoagulant therapy, e.g. warfarin/low molecular weight heparin or Anti-Xa-inhibitors and other NOACs, if temporary cessation medically not justifiable * Current urinary tract infection (UTI) or prostatitis ARM 2 Inclusion Criteria: * Male patients aged 18 years and older cT¬2-T3 / cN0-N1 / cM0 Any Group Grade (GG) 2-5: this includes Gleason scores 3+4, 4+3, 4+4, 4+5, 5+3, 5+4, 5+5. Any PSA * Histologically proven adenocarcinoma of the prostate * Undergoing radical prostatectomy as primary treatment for localised prostate cancer * World Health Organisation (WHO) performance status 0 to 2 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 months * No prior local and/or systemic treatment for localised prostate cancer * Willing to donate cancer tissue samples for research purposes (any metastasis and primary tumour) Exclusion criteria: * Involvement in the planning and/or conduct of the study (applies to staff at the study site) * As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. uncompensated respiratory, cardiac, hepatic or renal disease) * Any investigational agents or study drugs from a previous clinical study within 30 days of the first tissue collection * Prior treatment of localized prostate cancer including radiotherapy and/or androgen-deprivation therapy * Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements * Contra-indications to MRI (incl. pacemakers etc.)
References
Publications (0)
Data not yet available
No reference posted for this study.