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Clinical Trial

Trial of eRapa in Prostate Cancer Patients

The Phase Ib trial is a dose-escalation study with consecutive enrollment and advancement of cohorts in an overlapping fashion every 6 weeks. Patients will be treated for a total of 3 months with the various dosing regimens as dictated per cohort of the trial. Formal safety assessments, to include safety labs, will be performed in two safety windows: at 4 weeks of treatment of all patients in each dosing cohort prior to enrollment of the next cohort, and again after completion of treatment for each dosing cohort. Additional safety assessments will be performed as needed based on the toxicity profile seen. If any dose limiting toxicity (DLT) is encountered in the first 3 patients/cohort, an additional 3 patients will be enrolled. If no further patients experience a DLT, then dose escalation will continue. If a second patient experiences a DLT, dose escalation will be halted and the previous dose declared to be the maximum tolerated dose (MTD).

Clinical Trial

Hormonal Therapy plus Radiation Therapy as Treatment for Prostate Cancer

The purpose of this study is determine which type of anti-hormonal therapy and radiation therapy will result in an improvement in survival in patients with “unfavorable” intermediate risk or “favorable” high risk prostate cancer.  The risk is the possibility or chances of the prostate cancer coming back after being treated. The primary objective is to see which treatment improves the duration of survival. The study will enroll 2,580 participants from many cancer centers in the US. In addition to other conditions for enrollment, men who were diagnosed with prostate cancer within the past 180 days and have no evidence of lymph node involvement by CT scan or MRI within the past 90 days may be enrolled. Men are not eligible for this study if the prostate or testes have been surgically removed. Men who have already been treated with brachytherapy or radiation to the pelvis or hormonal therapy are not enrolled. Patients with a history of other cancers may not be eligible.

Clinical Trial

Radiation Therapy With or Without Apalutamide in Treating Patients With Stage III-IV Prostate Cancer

This phase II trial studies how well radiation therapy with or without apalutamide works in treating patients with stage III-IV prostate cancer. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgen can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may lessen the amount of androgen made by the body. Giving radiation therapy and apalutamide may work better at treating prostate cancer than radiation alone.

Clinical Trial

A Randomized Controlled Trial of ProstAtak as Adjuvant to Up-Front Radiation Therapy for Localized Prostate Cancer (CTMS# 19-0098)

The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in combination with radiation therapy for patients with intermediate-high risk localized prostate cancer. ProstAtak kills tumor cells and stimulates a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. ProstAtak has shown synergy with radiation without added toxicity and lower than expected recurrence rates in previous clinical trials. The hypothesis is that ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak or control arm at a 2:1 ratio. Both arms receive standard external beam radiation therapy. Short-term androgen deprivation therapy may be given but is not required.