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HDR Brachytherapy, EBRT and STAD for the Treatment of Prostate Cancer
Phase 1, PHASE2 trial testing HDR Brachytherapy + EBRT + STAD in Prostate Cancer - Recurrent in 3 participants. Terminated before completion.
| Lead sponsor | Loyola University |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 3 |
| Start date | 20 December 2017 |
| Primary completion | 26 July 2024 |
| Estimated completion | 26 July 2024 |
| Sites | 1 location across United States |
Loyola University
Adults 18 to 99, male only, with Prostate Cancer - Recurrent. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The primary outcome in this study is the number of participants with an acute grade ≥3 radiation-related genitourinary toxicity as described by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
| Group | Value | 95% CI |
|---|---|---|
| HDR Brachytherapy + EBRT + STAD | 0 |
A secondary outcome in this study is the number of participants with an acute grade ≥3 radiation-related gastrointestinal toxicity as described by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
| Group | Value | 95% CI |
|---|---|---|
| HDR Brachytherapy + EBRT + STAD | 1 |
The purpose of this study is to evaluate the safety and effectiveness of combining high-dose-rate (HDR) brachytherapy with external beam radiotherapy (EBRT) to the pelvis and 6 months of hormonal therapy, otherwise known as short term androgen deprivation therapy (STAD), as treatment for prostate cancer that has come back in the prostate and pelvic lymph nodes after prior radiotherapy. The study will examine the side effects of the treatment as well as the ability of the treatment to get rid of the cancer. This involves the placement of a radioactive material in the affected area of the prostate temporarily, and then is subsequently removed using a minimally invasive technique. Participants will also receive external radiation for 5 weeks targeting the pelvis and giving a higher dose each day to the suspicious lymph nodes on PET scan. Radiation therapy will start approximately 2 months after the start of the Androgen Deprivation Therapy (hormone therapy). The hormone therapy consists of two medications, an oral medication taken daily 2 months before starting radiation therapy until the last of the radiation therapy and an injection of a medication which is given 2 months prior to the start of radiation. Patient are then followed at specific time intervals to evaluate the treatment side effects and cancer control
No peer-reviewed publications indexed yet for this trial.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing