Lymphatic Metastasis, Prostatic Neoplasms
Conditions
Keywords
Quality of Life, Radiotherapy, Radiotherapy, dose-escalation
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.
Interventions
RADIATIONSIB Dose-Escalation Radiotherapy
Sponsors
Umeå University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
Sweden
Outcome results
None listed