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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase 2 Study of High Risk Prostatae Cancer Treated With Dose-escalated Simultaneous Integrated Boost to Prostate and Lymph Node GTV

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 Summary:
Sponsor: Umeå University

Current Primary Outcome: PSA progression free survival [ Time Frame: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome: Quality of Life [ Time Frame: 0,6,12,36,60 months ]

Questionnaires distributed to patients at these time intervals


Original Secondary Outcome: Same as current

Information By: Umeå University

Dates:
Date Received: October 9, 2013
Date Started: March 2015
Date Completion: November 2022
Last Updated: October 26, 2016
Last Verified: October 2016