Prostate Cancer
Conditions
Keywords
HYPOFRACTIONED
Brief summary
Radiotherapy is a standard definitive treatment for men with localized prostate cancer. Recent improvements in technology allow high doses of radiation to be delivered to the prostate in less days with lower doses to surrounding healthy tissues, trying to reduce side effects. This study is being proposed to evaluate the use of moderate hypofractionated volumetric radiotherapy in localized prostate cancer patients and assessing treatment -related later adverse events using the CTCAE 4.0
Detailed description
Recent evidence suggests that the same or better outcomes might be achieved in prostate cancer by ussing a higher dose of radiation per fraction ( 3Gy) with the consequent decrease in total days Quality of life outcomes as well as gastrointestinal and genitourinary late toxicities will be analyzed. It is thought that this regimen will produce comparable findings and would result in substantial health care cost savings, as well as, be more convenient for patients.
Interventions
RADIATIONHypofractionated volumetric radiotherapy in 20 fractions
Hypofractionated radiotherapy at 3 Gy per fraction for localized prostate cancer.
Sponsors
Consorci Sanitari de Terrassa
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologic confirmation of adenocarcinoma of the prostate by biopsy * Performance Status 0-2 * Signed informed consent form
Exclusion criteria
* Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies * Anticoagulant treatment, individual assessment of antiplatelet therapy * Previous pelvic radiotherapy * Previous surgery for prostate cancer * Previous transurethral resection of the prostate * History of Crohn's Disease or Ulcerative Colitis * Antecedents of rectal fistulas in the last 10 years * Previous significant urinary obstructive symptoms * Previous chemotherapeutic treatments * Non-compliance with constraints established in this protocol (see special section
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-related adverse events assessed by CTCAE v4.0 | Participants should be followed continuously, for the duration of 10 years | Number of patients with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical relapse free survival | Participants should be followed continuously, for the duration of 10 years | By Phoenix definition ( Nadir + 2 ng/ml) Participants should be followed at baseline and follow-up, for the duration of 10 years |
Countries
Spain
Outcome results
None listed