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A first step towards ultra-hypofractionation for unfavourable intermediate and high-risk prostate cancer: a prospective safety and feasibility study in patients with metastatic prostate cancer

A first step towards ultra-hypofractionation for unfavourable intermediate and high-risk prostate cancer: a prospective safety and feasibility study in patients with metastatic prostate cancer - UPRATE

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51909
Enrollment
61
Registered
2022-01-19
Start date
2022-06-15
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

prostate cancer

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Histologically proven prostate cancer • Radiologically proven limited metastatic disease • Referred to the Erasmus MC, after multidisciplinary consensus, for local radiotherapy treatment, similar to the STAMPEDE trial • Willing to and capable of personally filling out online questionnaire • Signed written informed consent

Exclusion criteria

Exclusion criteria: • Previous pelvic radiotherapy or surgery for prostate cancer (excluding surgery to improve urinary function in benign prostate hyperplasia, i.e. trans-urethral resection of the prostate or prostatectomy according to Millin or Hryntschak). • According to current clinical protocols, at discretion of the treating physician, patients can be excluded in case of, for example, an IPSS score of >20 or a prostate volume of >90ml, expecting an unacceptable rise in toxicity • Bilateral hip-replacement surgery, which compromises the visibility of the target area on the in-room CT-scan

Design outcomes

Primary

MeasureTime frame
Main endpoint: Percentage of patients for which in 0 or 1 out 6 fractions the SV were underdosed. Underdosage being defined as 95% of the volume of SV receiving =90% of patients received successful treatments.

Secondary

MeasureTime frame
Secondary endpoints: Quantify and assess toxicity using questionnaires. Quantify and assess target coverage and OAR dose when only the prostate is targeted.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)