Clinical Trials

Clinical trials are research studies in which patients may volunteer to take part. MD Anderson uses clinical trials to find better ways to prevent, diagnose and treat cancer. Doctors use treatment trials to learn more about how to fight cancer.

The current breast cancer clinical trials are listed below. Find more information on clinical trials at MD Anderson.

2018-0703         
Post Operative External Beam Radiotherapy For Prostate Cancer: Randomized Trial Comparing Standard Vs. Hypofractionated Radiation Therapy. (PORT-HYFX)   

This phase III trial studies how well hypofractionated radiation therapy works compared to the conventional one in treating patients with prostate cancer. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

2023-0006 
A randomized trial of maintenance Systemic Therapy after Radiation for Oligometastatic Renal Cell Carcinoma (ASTROs)

To learn if adding 1 year of therapy with pembrolizumab can help to continue to control RCC after radiation therapy. To evaluate PFS in patients randomized to definitive RT followed by pembrolizumab versus definitive RT followed by observation. To evaluate overall survival (OS) in patients randomized to definitive RT followed by maintenance pembrolizumab versus definitive RT followed by observation. To evaluate time to next line systemic therapy (defined as systemic therapy given after pembrolizumab) in patients randomized to definitive RT followed by maintenance pembrolizumab versus definitive RT followed by observation. To evaluate local recurrence free survival (LRFS) in patients randomized to definitive RT followed by maintenance pembrolizumab versus definitive RT followed by observation. To evaluate distant recurrence free survival (DRFS) in patients randomized to definitive RT followed by maintenance pembrolizumab versus definitive RT followed by observation. To evaluate estimate PFS2, LRFS2, and DRFS2 in patients who crossed over from one randomization arm to the other arm. To evaluate frequency of adverse events (AEs) in patients randomized to definitive RT followed by maintenance pembrolizumab versus definitive RT followed by observation.

To determine the association of translational biomarkers including peripheral blood markers and tissue markers with patient outcomes. To determine changes in translational biomarkers including peripheral blood markers and tissue markers after receipt of definitive RT.

2024-0070          
EXTENDing efficacy of systemic therapy with local consolidative therapy for OligoProgressive metastatic disease (EXTEND-OP): a randomized phase II basket trial    

To find out if local consolidation therapy (such as radiation therapy with or without other local therapies such as surgery, ablation [the removal or destruction of a body part or tissue or its function], or embolization [a procedure that uses particles, such as tiny gelatin sponges or beads, to block a blood vessel]) to all progressive sites of disease can help to control the disease compared with next-line systemic therapy.

2024-0001          
NRG-GU010: Parallel phase III randomized trials of genomic-risk stratified unfavorable intermediate risk prostate cancer: De-intensification and intensification clinical trial evaluation (guidance).

This phase III trial uses the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient's cancer aggressiveness. The Decipher risk score evaluates a prostate cancer tumor for its potential for spreading. In patients with low risk scores, this trial compares radiation therapy alone to the usual treatment of radiation therapy and hormone therapy (androgen deprivation therapy).

Radiation therapy uses high energy x-rays or particles to kill tumor cells and shrink tumors. Androgen deprivation therapy blocks the production or interferes with the action of male sex hormones such as testosterone, which plays a role in prostate cancer development. Giving radiation treatment alone may be the same as the usual approach in controlling the cancer and preventing it from spreading, while avoiding the side effects associated with hormonal therapy. In patients with higher Decipher gene risk, this trial compares the addition of darolutamide to usual treatment radiation therapy and hormone therapy, to usual treatment. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. The addition of darolutamide to the usual treatment may better control the cancer and prevent it from spreading.

2021-0131 
NRG-GU009: Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk with Radiation (PREDICT-RT*)

This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score.

2023-0893          
PRORAD-5 PROstate RADiation in 5 fractions: Phase Ib Five Fraction Radiotherapy for Patients with Advanced Prostate Cancer          

To look at the safety and effectiveness of stereotactic body radiation therapy (SBRT) in treating advanced or high-risk prostate cancer. To determine the proportion of patients experiencing late grade>= 3 GI toxicity after five fraction pelvic nodal RT as reported by the treating physician at 3 months post-treatment. To estimate the change in health-related quality of life (HRQOL) following the proposed treatment regimen compared to pre-treatment assessment 6 months after completing RT. Patient-reported urinary, bowel, and sexual function and general QoL will be collected using validated EPIC-26, EQ-5D, PROMIS-Fatigue questionnaires prior to RT, at the end of RT 3, and 6, 12, 24 months after completion of RT. To estimate the rate of acute and late GI and GU toxicity of the treatment regimen. To assess adherence to protocol treatment parameters. RT plans will be evaluated for contouring consistency, target coverage and tissue constraint adherence with the use of artificial intelligence (AI) auto-segmentation/contours and scorecards to facilitate this process and improve plan quality and clinical efficiency. To explore the impact of five fraction pelvic nodal RT on lymphopenia. White blood cell counts will be obtained before and after treatment and compared to historical data on lymphopenia with conventionally fractionated pelvic RT. To estimate HRQOL following the proposed treatment regimen compared to pre-treatment assessment at the end of RT 3 months, 12, and 24 months after completing RT and assess the HRQOL change over time. To investigate the effect of pelvic nodal RT on gut microbiome with gut microbiome sample collection pre- and post-RT.

2024-0154          
NRG-GU013: The phase III "High Five Trial" five fraction radiation for high-risk prostate cancer       

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.