Status:
UNKNOWN
Conformal Radiotherapy (CRT) Alone Versus CRT Combined With HDR BT or Stereotactic Body Radiotherapy for Prostate Cancer
Lead Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the outcomes of conventionally fractionated conformal radiotherapy with CF-CRT combined with either high-dose-rate brachytherapy or stereotactic body radiothera...
Detailed Description
Prostate cancer is considered as a disease with relatively slow natural course and good clinical prognosis. Such description, however, does not well refer to intermediate and high-risk cases where lon...
Eligibility Criteria
Inclusion
- Pathologically proven adenocarcinoma of the prostate
- Clinical stage T1-T3a (Intermediate or high risk features according to NCCN criteria)
- No evidence of nodal or distant spread as determined by chest X-ray, bone scan and abdominal ultrasound or CT-scan or other investigations such as Positron Emission Tomography \[PET\] scan if required
- No evidence of bulky spread beyond the capsule of the prostate, no seminal vesicle involvement assessed by TRUS or MRI of pelvis.
- Good performance status (ZUBROD \<2, Karnofsky index \>=80%).
- No contradictions for spinal anesthesia.
- No contradictions for hormonal treatment (androgen deprivation).
- Adequate bone marrow, renal and liver function.
- Life expectancy in excess of 5 years.
- No prior malignancy, except basal or squamous cell skin cancer.
- Informed consent for participation in the study (confirmed by the signature together with the standard medical consent form for radiotherapy within the pelvis)
Exclusion
- Different histology than adenocarcinoma.
- Previous or concurrent malignancy, with the exception of basal cell carcinoma of the skin.
- Locally advanced disease: bulky T3a and/or T3b.
- Presence of metastatic disease (nodal and/or distant).
- PSA \>100ng/ml
- Any previous therapy other than hormonal treatment.
- Concurrent uncontrolled medical conditions.
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
- Withdrawal of informed consent.
- \-
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT01839994
Start Date
June 1 2013
End Date
December 1 2018
Last Update
April 25 2013
Active Locations (1)
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1
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch
Gliwice, Silesian Voivodeship, Poland, 44-100