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

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

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56376
Enrollment
228
Registered
2023-07-28
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-09

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

Conditions

prostate cancer

Interventions

Hypofractionated pelvic radiotherapy with boost to primary tumor in the prostate

Sponsors

Haaglanden Medisch Centrum
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: o T3 based on digital rectal examination AND/OR o Grade >= 4 AND/OR o 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) 50 • 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 4 years; pattern of failure (based on PSMA in case of biochemical recurrence)—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)