The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over Post-Prostatectomy Biochemical Recurrence for a research study. The purpose of this study is to compare the usual treatment alone to the usual treatment plus additional treatment based on results of PET imaging that looks for cancer that has spread outside of the pelvis. If the PET scan finds areas of tumor outside of the pelvis (e.g., metastases, or metastatic lesions), we want to see if treating these areas with targeted, metastasis-directed radiation can improve cancer control. We also want to see whether adding apalutamide +/- targeted radiation works better than the usual approach to help treat prostate cancer that has returned after surgery. Apalutamide is approved by the FDA for treatment of metastatic castration-sensitive prostate cancer and non-metastatic castration-resistant prostate cancer.
The study involves receiving the PET imaging and study interventions, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as having your blood drawn, and talking to the study doctor. This study has 4 study groups. You will be randomly assigned to a treatment group depending on whether imaging shows that the cancer has spread beyond (outside of) the pelvis.
• Group 1 (Negative for Extra Pelvic-Metastases)
If you are in this group, it means your PET scan did not show evidence that your cancer has spread to areas outside of the pelvis. You will get the usual appropriate care that is used to treat this type of cancer, the planned standard of care treatment with radiation therapy (SOC RT) and short-term androgen deprivation therapy (STAD) for 6 months.
• Group 2 (Negative for Extra Pelvic-Metastases)
If you are in this group, it means your PET scan did not show evidence that your cancer has spread to areas outside of the pelvis. You will get the study treatment (apalutamide), planned SOC RT + STAD + apalutamide for 6 months.
• Group 3 (Positive for Extra Pelvic-Metastases)
If you are in this group, it means that your PET scan shows that your cancer appears to have spread to areas outside of your pelvis. You will get planned SOC RT + STAD + apalutamide for 6 months.
• Group 4 (Positive for Extra Pelvic-Metastases)
If you are in this group, your PET scan shows that your cancer appears to have spread to areas outside of your pelvis. You will get planned SOC RT + STAD + apalutamide for 6 months + radiation therapy directed to where the cancer has spread.
The apalutamide will be provided by the study at no cost to you. All additional procedures required by the study beyond your standard care, including laboratory tests, are provided to you at no charge.
Additional information can be found here: https://clinicaltrials.gov/study/NCT04423211
No Compensation