NCT01962324 - Dose Escalation With SIB to Intraprostatic/Lymphatic GTV in High Risk Prostate Cancer | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Enrollment

85

Conditions

Prostatic Neoplasms Lymphatic Metastasis

Interventions

SIB Dose-Escalation RadiotherapyRADIATION

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Umeå University, Cancercenter

Umeå, Sweden

Outcomes

Primary Outcomes

PSA progression free survival

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)

Time frame: 36 months

Secondary Outcomes

Genitourinary Quality of Life

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

Time frame: 0 6 12 36 60 months

Gastrointestinal Quality of Life

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

Time frame: 0 6 12 36 60 months

Overall Quality of Life

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

Time frame: 0 6 12 36 60 months

Sexual Quality of Life

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

Time frame: 0 6 12 36 60 months