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

Withdrawn

• Conditions: prostate cancer; 10038597

• Registration Number: NL-OMON56376
• Lead Sponsor: Haaglanden Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 228

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

• 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 to MRI
• no visible lesion on MRI in prostate for boost
• no PSMA-PET scan
• inflammatory bowel disease
• metastatic disease (M1)
• PSA >50
• unsuitable for SBRT or WPRT
• medical history of cancer other than basal cell carcinoma of the skin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Biochemical recurrence free survival and late toxicity </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Overall survival; Metastasis Free survival at 4 years; pattern of failure<br /><br>(based on PSMA in case of biochemical recurrence)</p><br>