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

Recruiting

Conditions: prostate cancer
10038364

Registration Number: NL-OMON51909

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 61

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

• 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main endpoint: Percentage of patients for which in 0 or 1 out 6 fractions the<br /><br>SV were underdosed. Underdosage being defined as 95% of the volume of SV<br /><br>receiving < 95% of prescribed dose. In the case of unavoidable underdosage of<br /><br>the target on the reference plan, coverage below the achieved coverage in the<br /><br>reference plan will be seen as an underdosed fraction. The margin reduction of<br /><br>the SV is considered feasible when >=90% of patients received successful<br /><br>treatments. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints: Quantify and assess toxicity using questionnaires.<br /><br>Quantify and assess target coverage and OAR dose when only the prostate is<br /><br>targeted.</p><br>