Active — Not RecruitingPhase 1

Stereotactic Ablative Radiotherapy (SABR) of Pelvis and Prostate Targets For High Risk Prostate Cancer

United States60 participantsStarted 2015-10

Plain-language summary

Since high risk prostate cancer requires higher radiation, this study is being done to determine the maximum tolerated dose of radiation to the prostate and pelvic regions. Also to determine the feasibility and safety of each treatment fraction by using cone-beam Computed Tomography(CT) information and high speed Graphics Processing Unit based computation treatment planning systems. We also plan to determine the safety of treatment to the prostate. Health-related quality of life will be measured as part of current clinical practice. * Determine the maximum tolerated dose (MTD) or to safely escalate dose to the pelvic nodal using 90 day acute toxicity endpoint * Determine feasibility and safety of adaptive real time re-planning of the pelvic nodal region at each treatment fraction by using cone-beam CT (CBCT) information and high speed GPU based computation treatment planning systems * Determine the safety and tolerability of 9.5 Gy per fraction in five fractions (47.5 Gy total dose) to the prostate * Determine the feasibility and safety of temporal enhanced ultrasound for prostate lesion tracking during radiation therapy * To follow tumor related outcomes (i.e. PSA control, progression-free survival (PFS), distant metastasis (DM) free survival, and overall survival (OS) * Health-related quality of life (HRQOL) will be measured as part of current clinical practice Patients in each dose cohort will all be treated as a single group for dose escalation. There will be two levels of dose escalation-to prostate lesions and to pelvic lymph node region. Prostate/SV PTV will be treated at a fixed dose of 9.5 Gy per fraction for 5 fractions (47.5 Gy) based on our previous phase I/II study experiences. The starting dose for the dose escalation to the pelvic region PTV will be 4.5 Gy per fraction for 5 fractions (total dose= 22.5 Gy). Subsequent cohorts of patients will receive an additional 0.5 Gy per treatment (total 2.5 Gy per escalation). The starting dose for MRI-visible prostatic lesions will be 10 Gy and subsequent cohorts will receive an additional 0.5Gy per treatment (total of 2.5Gy per escalation).

Who can participate

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Signed study specific informed consent form. * Patients must have at least one of the following criteria: * The serum PSA should be greater than or equal to 20 ng/ml OR * Study entry PSA must not be obtained during the following time frames following prostate biopsy: (2) following initiation of ADT. * The Gleason score should be greater than or equal to 8 OR * Eligible patients must have appropriate staging studies identifying them as AJCC stage T3+ adenocarcinoma of the prostate gland. (MR stage T3a without other high risk factors permitted at investigator discretion * Male Patient past their 18th birthday at time of registration. * The patient's Zubrod performance status must be 0-2 * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, and during radiation treatment. * All patients must be willing and capable to provide informed consent to participate in the protocol * Imaging studies can include, but is not limited to the following: ultrasound, CT of pelvis/prostate (abdomen recommended) and MRI of pelvis/prostate and (abdomen recommended) * The ultrasound, MRI or CT based volume estimation of the patient's prostate gland should not be greater than 80 grams (Repeat measurement after hormone downsizing allowed) * Clinically negative lymph nodes, within 90 days of study enrollment, established by imaging (pelvic/prostate (abdominal recommended)…

What they're measuring

maximum tolerated dose (MTD)

Timeframe: 90 days

Trial details

NCT IDNCT02353819

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-01