Status:
RECRUITING
Phase II Study of Single-Dose Image-Guided Radiotherapy (SDRT) for Prostate Cancer
Lead Sponsor:
Fundacao Champalimaud
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The present study evaluates clinical outcomes and treatment-related toxicity following definitive ultra-high single dose external beam radiotherapy delivered to patients with low- or intermediate-risk...
Detailed Description
The present phase II study evaluates the clinical outcomes and potential treatment-related toxicity following definitive ultra-high dose single fraction external beam radiation therapy (SDRT) in patie...
Eligibility Criteria
Inclusion
- Signed study specific informed consent form;
- Histologic confirmation of adenocarcinoma of the prostate by biopsy;
- Up to 6 months of previous hormonal therapy is allowed (but not required)
- PSA ≤ 20 prior to hormone therapy (if given);
- Biopsy Gleason score ≤ 7
- No direct evidence of regional or distant metastases after appropriate staging studies
- Age ≥ 18
- Performance Status 0-2
- American Urological Association (AUA) score must be ≤ 20 (alpha blockers allowed)
- Computerized Tomography (CT) or Ultrasound-based volume estimation of prostate gland ≤ 100 grams
Exclusion
- Positive lymph nodes or metastatic disease from prostate cancer on imaging studies
- Prior invasive malignancy unless disease free for a minimum of 3 years
- MRI evidence of radiographic T3, T4 or N1 disease
- Tumour Clinical stage T3 or T4 on MRI
- PSA \> 20 ng/mL
- Gleason score \> 7
- Previous pelvic radiotherapy
- Previous surgery for prostate cancer
- Recent transurethral resection of the prostate (TURP) (less than 3 months)
- Previous hormonal therapy given for more than 6 months prior to therapy
- Previous significant urinary obstructive symptoms;
- Significant psychiatric illness
- Ultrasound or CT estimate of prostate volume \> 100 grams
- Severe, active co-morbidity.
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04035642
Start Date
June 1 2019
End Date
June 1 2026
Last Update
July 29 2019
Active Locations (1)
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1
Champalimaud Foundation
Lisbon, Portugal, 1400-038