Conformal Radiotherapy (CRT) Alone Versus CRT Combined With HDR BT or Stereotactic Body Radiotherapy for Prostate Cancer
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer,, high-dose-rate brachytherapy boost,, stereotactic body radiotherapy boost,, conformal radiotherapy,, randomized trial
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
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Sites / Locations
- Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
CF-CRT combined with BT or SBRT boost
CF-CRT alone
Conventionally fractionated CRT (IMRT or Rapid Arc) to the TD of 50 Gy, 2.0 Gy d fx, 5 days a week over the period of 5 weeks AND two 10 Gy fractions of real- time HDR brachytherapy OR CRT combined with two stereotactic body radiotherapy boosts of 10 Gy per fraction delivered with dynamic SBRT technique (IMRT or Rapid Arc). The choice between two ways of delivering radiation dose to the boost volume will be based solely on clinical criteria, decision made by interdisciplinary team, according to the institutional protocol (in non-randomized fashion). Hormonal treatment: three months of neoadjuvant androgen deprivation (MAB -maximal androgen blockade) in all patients. Long-term (3 years) of adjuvant hormonotherapy (LHRH agonists only) in high risk patients.
Conventionally fractionated external beam conformal radiotherapy (IMRT or Rapid Arc) to the prostate and seminal vesicles (intermediate risk group) or to the prostate, SV and pelvic lymph nodes (high risk group) to the total dose of 50 Gy in 2.0 Gy per fraction, 5 days a week over the period of 5 weeks, followed by a boost to the prostate (26 or 28 Gy in 2.0 Gy per fraction 5 days a week over the period of 2.5 weeks) to the total dose of 76 or 78 Gy (intermediate or high risk group of patients, respectively). Hormonal treatment: three months of neoadjuvant androgen deprivation (MAB -maximal androgen blockade) in all patients. Long-term (3 years) of adjuvant hormonotherapy (LHRH agonists only) in high risk patients.