This clinical trial compares the effect of image guided tumor focused radiation therapy to standard whole prostate radiation therapy in treating patients with intermediate and high-risk prostate cancer. Definitive radiation therapy for prostate cancer with dose intensification and/or focal boosting has excellent outcomes. However, many patients experience long-term toxicity. Common acute side effects of radiation therapy to the pelvis include fatigue, lower urinary tract symptoms, bowel symptoms, and sexual dysfunction. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Image guided radiation therapy is procedure that uses a computer to create a picture of a tumor to help guide the radiation beam during radiation therapy. The pictures are made using computed tomography, ultrasound, x-ray, or other imaging techniques. Researchers think that if they are able to see the tumor well, they can target the tumor with high doses of radiation, while the rest of the prostate and nearby organs will receive lower doses. Lower doses of radiation to the rectum and the bladder may result in fewer and less severe gastrointestinal and urinary side effects and better quality of life, both within a few months of the therapy and longer term in patients with intermediate and high-risk prostate cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06990542.
Locations matching your search criteria
United States
California
La Jolla
UC San Diego Moores Cancer CenterStatus: Active
Contact: Tyler M Seibert
Phone: 858-246-5988
PRIMARY OBJECTIVE:
I. To demonstrate superiority of image-guided, tumor-focused radiotherapy versus standard dose radiotherapy for acute genitourinary or gastrointestinal toxicity in the setting of definitive radiotherapy for intermediate- and high-risk prostate cancer.
SECONDARY OBJECTIVES:
I. To compare acute and late toxicity between tumor-focused radiotherapy and standard dose radiotherapy.
II. To compare patient-reported urinary and bowel quality of life between tumor-focused radiotherapy and standard dose radiotherapy.
III. To compare biochemical recurrence free survival between tumor-focused radiotherapy and standard dose radiotherapy.
IV. To compare rates of local failure between tumor-focused radiotherapy and standard dose radiotherapy.
V. To compare distant metastasis free survival between tumor-focused radiotherapy and standard dose radiotherapy.
VI. To compare overall survival between tumor-focused radiotherapy and standard dose radiotherapy.
TERTIARY/EXPLORATORY OBJECTIVE:
I. To investigate prognostic biomarkers predictive of predisposition to toxicity.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard radiation therapy in 5 to 40 fractions for 1 to 15 weeks. Patients also undergo blood sample collection and magnetic resonance imaging (MRI) and optional prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) throughout the trial.
ARM II: Patients undergo image-guided tumor-focused radiation therapy with high doses of radiation to the tumor and lower doses outside of the tumor area in 5 to 40 fractions for 1 to 15 weeks. Patients also undergo blood sample collection and MRI and optional PSMA PET/CT throughout the trial.
After completion of study treatment, patients are followed up at 3, 6, 12, 18 and 24 months and then every 6 months for 3 years.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUC San Diego Moores Cancer Center
Principal InvestigatorTyler M Seibert
