Androgen Suppression Combined With Elective Nodal Irradiation and Dose Escalated Prostate Treatment: A Non-Inferiority, Phase III Randomized Controlled Trial of Stereotactic Body Radiation Therapy Versus Brachytherapy Boost in Patients With Unfavourable Risk Localized Prostate Cancer
Summary
This study is being done to answer the following question: Is the strategy to give higher doses of radiotherapy treatment over a shorter period of time using special equipment and fewer treatments (also known as Stereotactic Body Radiation Therapy or SBRT) as effective as usual external radiation therapy given with a brachytherapy boost (which involves radiation sources inserted directly into the prostate)?
Detailed description
The usual approach for patients with unfavourable prostate cancer who are not in a study is treatment with external beam radiation therapy (EBRT) to the pelvis and prostate in combination with hormone therapy (androgen deprivation therapy - ADT). To improve control of prostate cancer at risk of returning, additional treatment with a brachytherapy boost (insertion of radiation sources directly into the prostate) is recommended. For patients who get the usual approach for this cancer, about 89 out of 100 are free of cancer after 5 years.
Arms & interventions
- RadiationRadiation
46Gy / 23 fractions of EBRT to pelvis and prostate + LDR or HDR boost to prostate OR 25Gy / 5 fractions of EBRT to pelvis and prostate (ultrahypofractionation EBRT (SBRT)) + LDR or HDR boost to prostate. \+ Adjuvant ADT: Unfavourable Intermediate Risk: 6 months or High / Very High Risk: 24 months
- RadiationRadiation SBRT only
25Gy / 5 fractions to pelvis + 40 Gy / 5 fractions to prostate (SBRT) (ultrahypofractionation EBRT (SBRT))
- DrugADT
Assigned at enrollment
Outcome measures
Primary
To compare the progression-free survival (PFS) of SBRT versus conventional EBRT plus brachytherapy boost defined as time to biochemical failure, initiation of salvage therapy, local-regional recurrence, distant progression, or death
Time frame: 8.6 years
Secondary
Safety and tolerability assessed by CTCAE v5.0
Time frame: 8.6 years
PSA response at 4 years compared using a Cochran-Mantel-Haenszel (CMH) test
Time frame: 8.6 years
Metastasis-free Survival compared using the Gray's test
Time frame: 8.6 years
Cause-specific Survival compared using the Gray's test
Time frame: 8.6 years
Overall Survival analysed using a Cox proportional hazards model and graphically described using the Kaplan-Meier method
Time frame: 8.6 years
Participant-reported outcomes using EPIC-26 questionnaire
Time frame: 8.6 years
Participant-reported tolerability using PRO-CTCAE questionnaire
Time frame: 8.6 years
Economic Outcomes using EQ-5D-5L
Time frame: 8.6 years
Economic Outcomes using FACIT-COST
Time frame: 8.6 years
Eligibility criteria
Study locations (46)
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531
Kaiser Permanente Dublin
Dublin, California, 94568
Kaiser Permanente-Fremont
Fremont, California, 94538
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, 93720
Kaiser Permanente-Fresno
Fresno, California, 93720
Kaiser Permanente-Modesto
Modesto, California, 95356
Kaiser Permanente Oakland-Broadway
Oakland, California, 94611
Kaiser Permanente-Oakland
Oakland, California, 94611
Kaiser Permanente- Marshall Medical Offices
Redwood City, California, 94063
Kaiser Permanente-Richmond
Richmond, California, 94801
Rohnert Park Cancer Center
Rohnert Park, California, 94928
Kaiser Permanente-Roseville
Roseville, California, 95661
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678
Kaiser Permanente Downtown Commons
Sacramento, California, 95814
Kaiser Permanente-South Sacramento
Sacramento, California, 95823
Kaiser Permanente-San Francisco
San Francisco, California, 94115
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119
Kaiser Permanente San Leandro
San Leandro, California, 94577
Kaiser San Rafael-Gallinas
San Rafael, California, 94903
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080
Kaiser Permanente-Stockton
Stockton, California, 95210
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, 95688
Kaiser Permanente-Vallejo
Vallejo, California, 94589
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596
Memorial Hospital East
Shiloh, Illinois, 62269
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Washington University School of Medicine
St Louis, Missouri, 63110
Siteman Cancer Center-South County
St Louis, Missouri, 63129
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
Billings Clinic Cancer Center
Billings, Montana, 59101
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
Manhattan Eye Ear and Throat Hospital
New York, New York, 10065
Lenox Hill Hospital
New York, New York, 10075
Saint Vincent Hospital
Erie, Pennsylvania, 16544
Jefferson Hospital
Jefferson Hills, Pennsylvania, 15025
Forbes Hospital
Monroeville, Pennsylvania, 15146
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, 15090
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, 23230
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298