Dose Escalation With SIB to Intraprostatic/Lymphatic GTV in High Risk Prostate Cancer

Not Applicable

Completed

• Conditions: Lymphatic Metastasis; Prostatic Neoplasms
• Interventions: Radiation: SIB Dose-Escalation Radiotherapy

• Registration Number: NCT01962324
• Lead Sponsor: Umeå University

Brief Summary

A single arm phase 2 study to study the outcome of dose-escalation with simultaneous integrated boost to intraprostatic lesion and positive lymph nodes. Prostate cancer patients with high risk of lymph node metastasis or oligo positive nodes in true pelvic area can be included. The boost volumes will be outlined by usin PET-CT and MRI data. Our hypothesis is that we will have fewer relapses in this very high risk patient group compared to matched historical controls with acceptable side effects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2013-10-11
• Study First Posted: 2013-10-14
• Study Start: 2015-03
• Primary Completion: 2023-05-09
• Study Completion: 2023-05-09
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 85

Inclusion Criteria

• Histologically confirmed high risk prostate cancer with a risk of lymphatic spread >15% according to the MSKCC nomogram (1) http://nomograms.mskcc.org/Prostate/PreTreatment.aspx
• Written informed consent
• > 18 years
• Fiducial gold markers implanted in the prostate (min 3)

Exclusion Criteria

• • Non MR-safe implants or other contraindication to MRI

  • WHO PS>1
  • Previous pelvic irradiation
  • TURP within 6 months
  • IPSS >19
  • Metastatic disease in skeleton, parenchymal organs or lymph nodes outside the pelvis
  • Creatinin clearance < 30ml/min according to http://www.fass.se/LIF/produktfakta/kreatinin.jsp

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SIB Dose-Escalation radiotherapy	SIB Dose-Escalation Radiotherapy	Simultaneous integrated boost to intraprostatatic tumor and lymph nodes

Primary Outcome Measures

Name	Time	Method
PSA progression free survival	36 months	PSA progression defined according to American Society for Therapeutic Radiology and Oncology (ASTRO) Phoenix definition: nadir PSA + 2 ng/mL (on three consecutive measurements with at least one month between each)

Secondary Outcome Measures

Name	Time	Method
Genitourinary Quality of Life	0 6 12 36 60 months	Questionnaires distributed to patients at these time intervals regarding side-effects in genitourinary and gastrointestinal domains The questionnaire used is PCSS, Prostate Cancer Symptom Scale The scale goes from 0 to 10 where 0-2 is considered no problems, 3-4 minor problems, 5-7 moderate and 8-10 severe
Gastrointestinal Quality of Life	0 6 12 36 60 months	Questionnaires distributed to patients at these time intervals regarding side-effects in genitourinary and gastrointestinal domains The questionnaire used is PCSS, Prostate Cancer Symptom Scale The scale goes from 0 to 10 where 0-2 is considered no problems, 3-4 minor problems, 5-7 moderate and 8-10 severe
Sexual Quality of Life	0 6 12 36 60 months	Questionnaires distributed to patients at these time intervals regarding side-effects in genitourinary and gastrointestinal domains The questionnaire used is PCSS, Prostate Cancer Symptom Scale The scale goes from 0 to 10 where 0-2 is considered no problems, 3-4 minor problems, 5-7 moderate and 8-10 severe
Overall Quality of Life	0 6 12 36 60 months	Questionnaires distributed to patients at these time intervals regarding side-effects in genitourinary and gastrointestinal domains The questionnaire used is PCSS, Prostate Cancer Symptom Scale The scale goes from 0 to 10 where 0-2 is considered no problems, 3-4 minor problems, 5-7 moderate and 8-10 severe

Trial Locations

Locations (1)

Umeå University, Cancercenter; 🇸🇪 Umeå, Sweden