Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SIB Dose-Escalation radiotherapy | Experimental | Simultaneous integrated boost to intraprostatatic tumor and lymph nodes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIB Dose-Escalation Radiotherapy | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0 6 12 36 60 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
• Non MR-safe implants or other contraindication to MRI
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Camilla Thellenberg Karlsson, MD | Umea University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Umeå University, Cancercenter | Umeå | 90185 | Sweden |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D008207 | Lymphatic Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | 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 | 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 | 0 6 12 36 60 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |