Status:
ACTIVE_NOT_RECRUITING
Hypofractionated, Dose Escalation Radiotherapy for High Risk Adenocarcinoma of the Prostate
Lead Sponsor:
Sir Mortimer B. Davis - Jewish General Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
In North America, around a quarter a million men are diagnosed with prostate cancer every year, and about 31,000 patients will die of their disease each year. Like other western countries, the inciden...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the prostate diagnosed within 6 months prior to randomization
- Patient has been classified as high risk defined clinically as: T3 or T4, Gleason Score \> 8, and/ or PSA \> 20 (ng/mL or μg/L).
- Pelvic and para-aortic lymph nodes must be negative on computerized tomography (CT scan) or magnetic resonance imaging (MRI) of the abdomen and pelvis performed within 12 weeks prior to randomization.
- Investigations, including chest X-ray or chest CT scan and bone scan (with radiographs of suspicious areas) have been performed within 12 weeks prior to randomization and are negative for metastases.
- Patients will have had a PSA test done at the time of diagnosis. This PSA test could be repeated within 28 days prior to randomization.
- The patient may have received prior androgen suppression therapy provided that androgen suppression therapy commenced no more than 28 days prior to randomization.
- The patient must not have received any cytotoxic anticancer therapy for prostate cancer prior to randomization.
- ECOG performance status must be 0 or 1
- Hematology and biochemistry: should be done within 28 days prior to randomization:
- Hemoglobin \> 100 g/L
- Absolute Neutrophils \> 1.5 x 109/L
- Platelets \> 100 x 109/L
- AST and/or ALT \< 1.5 x Upper Limit of Normal (ULN)
- Alkaline phosphatase \< 2.5 x Upper Limit of Normal (ULN)
- Total bilirubin \< ULN
- Serum creatinine \< 1.5 x ULN
- adequate birth control measures should be used by the participant
- Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements.
- Patients must be accessible for treatment and follow-up.
Exclusion
- Patients with a history of other malignancies, except: non-melanoma skin cancer; or other solid tumours curatively treated with no evidence of disease for \> 5 years.
- The presence of small-cell or transitional-cell carcinoma in the biopsy specimen.
- Patients who had previous chemotherapy for carcinoma of the prostate.
- Patients who had prior surgical treatment for carcinoma of the prostate apart from trans-urethral resection, including bilateral orchiectomy.
- Patients with any contraindication to pelvic radiotherapy: including, but not limited to, previous pelvic radiotherapy, inflammatory bowel disease or severe bladder irritability.
- Patients with serious non malignant disease resulting in a life expectancy less than 3 years.
- Other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol
- Known hypersensitivity to any protocol-indicated study medications.
- Presence of bilateral hip replacement prostheses.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
329 Patients enrolled
Trial Details
Trial ID
NCT01444820
Start Date
January 1 2012
End Date
January 1 2026
Last Update
December 4 2024
Active Locations (12)
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1
Horizon Health Network - Saint John Regional Hospital
Saint John, New Brunswick, Canada
2
Complexe hospitalier de la Sagamie
Chicoutimi, Quebec, Canada
3
Hôpital de Gatineau
Gatineau, Quebec, Canada
4
Hôpital Charles-Lemoyne
Greenfield Park, Quebec, Canada