Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer With Rising PSA After Radical Prostatectomy

ConditionsProstate Adenocarcinoma Stage IIIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8 Stage IIIC Prostate Cancer AJCC v8 Stage IV Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexMale

Age18+

SponsorJonsson Comprehensive Cancer Center

About this trial

This phase II trial investigates the effect of extremely hypofractionated intensity modulated stereotactic body radiotherapy in treating patients with prostate cancer that has rising prostate specific antigen (PSA) after radical prostatectomy. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Eligibility criteria

Qualifiers

History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent

Adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, OR presence of tertiary Gleason grade 5 disease)

Documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng/mL

Intermediate- or high-risk Decipher genomic classifier score

Disqualifiers

Patients with any evidence of distant metastases. Note, evidence of lymphadenopathy below the level of the renal arteries can be deemed loco regional per the discretion of the investigator

Patients with neuroendocrine or small cell carcinoma of the prostate

Prior pelvic radiotherapy

History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia

Trial design

Treatments tested in this trial

Hormone Therapy
Stereotactic Body Radiation Therapy

Treatment groups

102 Participants

are divided into 1 treatment group

Sponsors and collaborators

Jonsson Comprehensive Cancer Center

Lead sponsor

Source ClinicalTrials.gov