Risk Stratified De-escalated Hormone Therapy With Radiation Therapy for the Treatment of Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
This phase II trial tests how well risk based de-escalated hormone therapy (i.e., fewer treatments) with radiation works in treating patients with prostate cancer. Androgen deprivation therapy (ADT), such as gonadotropin-releasing hormone analogs (LHRH) and abiraterone acetate (Zytiga), lower the amount of the male hormone, testosterone, made by the body. This may help kill or stop the growth of tumor cells that need testosterone to grow. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Research has shown that long-term ADT is beneficial for patients with high-risk prostate cancer. However, there are few studies that determine ADT treatment based on risk factors. Giving risk based de-escalated ADT with radiation therapy may be as effective as giving more ADT in treating high-risk prostate cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed high risk prostate adenocarcinoma
Pathologic stages T1c-T4, N0-Nx-N1, M0-1 as staged by the pathology report (AJCC Criteria 8th Edition [Ed].)
One or more high risk features including Gleason 8-10, T3-T4, prostate specific antigen (PSA) ≥ 20
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Disqualifiers
Previous pelvic radiation
Prior androgen suppression therapy for prostate cancer for more than 6 months
Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed)
Prior systemic chemotherapy for prostate cancer
Trial design
Design model
Parallel
Treatments tested in this trial
Abiraterone Acetate
DrugGiven abiraterone acetate
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Computed Tomography
Procedure/SurgeryUndergo CT
Gonadotropin-releasing Hormone Analog
Biological/VaccineGiven SC or IM
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Positron Emission Tomography
Procedure/SurgeryUndergo PET
Questionnaire Administration
Other interventionAncillary studies
Radiation Therapy
RadiationUndergo radiation therapy
Treatment groups
110 Participants
are divided into 3 treatment groupsGroup A: Group I (radiation therapy)Experimental treatment 6 interventions
Group B: Group II (ADT, radiation therapy)Experimental treatment 7 interventions
Group C: Group III (ADT, radiation therapy, abiraterone acetate)Experimental treatment 8 interventions
Trial outcomes
Primary outcomes
1
Hormonal domain scores
Measured by the Expanded Prostate Cancer Index Composite. Comparison will be made using a one-sided, paired-difference t-test, with a Type I error rate of 0.025.
Time frame
At baseline and up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov