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HypoPRIME

Towards optimal treatment for high risk prostate cancer; stereotactic pelvic radiotherapy with focal boost to the primary tumor - HypoPRIME

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57329
Enrollment
207
Registered
2023-10-17
Start date
2024-01-02
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

Men with high risk prostate cancer with an indication for elective lymph node irradiation. Hypofractionated pelvic radiotherapy with boost to primary tumor in the prostate

Sponsors

Haaglanden Medisch Centrum (HMC)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Men (aged >18 years of age) diagnosed within 6 months before inclusion with high risk prostate cancer. T3 based on digital rectal examination AND/OR Grade >= 4 AND/OR PSA >=20 ug/L Indication for elective lymph node irradiation (based on current clinical guidelines) OR N1 on imaging (with a maximum of 4 suspect lymph nodes)

Exclusion criteria

Exclusion criteria: Prior pelvic radiotherapy  TransUrethral Resection of the Prostate (TURP) < 3 months ago  Prostatectomy or other primary treatment for prostate cancer (e.g. HIFU, cryotherapy, etc) Contraindications undergoing an MRI No visible lesion on MRI in prostate for boost No PSMA-PET scan Inflammatory bowel disease Metastatic disease (M1 ) Unsuitable for SBRT or WPRT Medical history of cancer other than basal cell carcinoma of the skin

Design outcomes

Primary

MeasureTime frame
Biochemical recurrence free survival and late toxicity

Secondary

MeasureTime frame
Overall survival; Metastasis Free survival at 5 years; pattern of failure (based on PSMA in case of biochemical recurrence)

Countries

Netherlands

Contacts

Public ContactM.E. Mast

Haaglanden Medisch Centrum (HMC)

m.mast@haaglandenmc.nl088-9792482

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)