Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorNRG Oncology
About this trial
This phase III trial compares stereotactic body radiation therapy (SBRT), (five treatments over two weeks using a higher dose per treatment) to usual radiation therapy (20 to 45 treatments over 4 to 9 weeks) for the treatment of high-risk prostate cancer. SBRT 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 of time. This trial is evaluating if shorter duration radiation prevents cancer from coming back as well as the usual radiation treatment.
Eligibility criteria
Qualifiers
Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer
cT3a-T3b by digital exam or imaging (American Joint Committee on Cancer [AJCC] 8th edition [Ed.]) Note: cT4 by imaging or on digital rectal exam is not allowed
The patient's prostate specific antigen (PSA) value > 20 ng/mL prior to starting androgen deprivation therapy (ADT) Note: Patients taking a 5-alpha reductase inhibitor (ex finasteride or dutasteride) are eligible The baseline PSA value should be doubled for PSAs taken while on 5-alpha reductase inhibitors
Gleason Score of 8-10
Disqualifiers
None
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Bone Scan
- Computed Tomography
- External Beam Radiation Therapy
- Magnetic Resonance Imaging
- Positron Emission Tomography
- Quality-of-Life Assessment
- Questionnaire Administration
- Stereotactic Body Radiation Therapy
Treatment groups
1,209 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov