Stereotactic Hypofractionated Accelerated Radiotherapy Post-Prostatectomy

Launched by FUNDACAO CHAMPALIMAUD · Nov 23, 2016

Keywords

ClinConnect Summary

The present study evaluates the feasibility of postoperative stereotactic hypofractionated external beam radiation therapy delivered in patients who underwent radical prostatectomy with adverse pathological features or early biochemical failure. Regardless the two settings (adjuvant or salvage), external beam radiation therapy for prostate cancer is usually a protracted course, since a total dose of 66 Gy to 70 Gy is needed to be effective. At the typical rate of 1.8 Gy to 2.0 Gy per treatment, it takes approximately 35 treatments over the course of 7 weeks to complete, which is very costly...

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Adenocarcinoma of the prostate treated with radical prostatectomy (any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted; there is no time limit for the date of radical prostatectomy)
• • Pathologic (p)T3 disease, positive margin(s), Gleason score 8-10, or seminal vesicle involvement
• • Undetectable post-radical prostatectomy PSA that becomes detectable and then increases on 2 subsequent measurements (PSA of \> 0.1 - ≤ 2.0 ng/mL)
• • Life expectancy: 10 years
• • ECOG performance status of 0 -1
• • No distant metastases, based on the following workup within 60 days prior to registration
• • Magnetic resonance imaging (MRI) of the pelvis
• • PSMA/Choline Positron Emission Tomography (PET) to exclude systemic disease in patients with biochemical recurrence
• • Patients can be on androgen deprivation therapy
• • Ability to understand and willingness to sign a study-specific informed consent prior to study entry
• Exclusion Criteria:
• • N1 patients are ineligible, as are those with lymph node (LN) enlargement \> 1.5 cm by computed tomography (CT) or MRI of the pelvis, unless the LN is biopsy proven to be negative.
• • Gross residual disease in the prostate fossa based on imaging evidence, unless biopsy proven not to contain cancer.
• • Prior radiation of any kind to the prostate gland or pelvis
• • Prior brachytherapy is not allowed
• • History of inflammatory colitis or other active severe comorbidities
• • Patients who are on immunosuppressant medication