RECRUITING

Risk Stratified De-escalated Hormone Therapy with Radiation Therapy for the Treatment Prostate Cancer

Description

This phase II trial tests how well risk based de-escalated hormone therapy (i.e., fewer treatments) with radiation works in treating patients with prostate cancer. Androgen deprivation therapy (ADT), such as gonadotropin-releasing hormone analogs (LHRH) and abiraterone acetate (Zytiga), lower the amount of the male hormone, testosterone, made by the body. This may help kill or stop the growth of tumor cells that need testosterone to grow. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Research has shown that long-term ADT is beneficial for patients with high-risk prostate cancer. However, there are few studies that determine ADT treatment based on risk factors. Giving risk based de-escalated ADT with radiation therapy may be as effective as giving more ADT in treating high-risk prostate cancer.

Conditions

Oligometastatic Prostate CarcinomaProstate Adenocarcinoma
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Related Conditions:

Oligometastatic Prostate CarcinomaProstate Adenocarcinoma

Study Overview

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Study Details

Study overview

This phase II trial tests how well risk based de-escalated hormone therapy (i.e., fewer treatments) with radiation works in treating patients with prostate cancer. Androgen deprivation therapy (ADT), such as gonadotropin-releasing hormone analogs (LHRH) and abiraterone acetate (Zytiga), lower the amount of the male hormone, testosterone, made by the body. This may help kill or stop the growth of tumor cells that need testosterone to grow. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Research has shown that long-term ADT is beneficial for patients with high-risk prostate cancer. However, there are few studies that determine ADT treatment based on risk factors. Giving risk based de-escalated ADT with radiation therapy may be as effective as giving more ADT in treating high-risk prostate cancer.

Risk Stratified De-Escalated De-Intensified Treatment for High Risk Prostate Cancer Patients Based on Pathologic Criteria, Genetic Score, and Biologic Imaging

Risk Stratified De-escalated Hormone Therapy with Radiation Therapy for the Treatment Prostate Cancer

Condition
Oligometastatic Prostate Carcinoma
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Mayo Clinic in Arizona, Scottsdale, Arizona, United States, 85259

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Histologically confirmed high risk prostate adenocarcinoma
  • * Pathologic stages T1c-T4, N0-Nx-N1, M0-1 as staged by the pathology report (AJCC Criteria 8th Edition \[Ed\].)
  • * One or more high risk features including Gleason 8-10, T3-T4, prostate specific antigen (PSA) ≥ 20
  • * Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • * Patients must sign institutional review board (IRB) approved study specific informed consent
  • * Patients must complete all required pre-entry tests
  • * Patients must be at least 18 years old
  • * Oligometastatic prostate cancer defined as disease in up to 5 distant or regional areas
  • * Previous pelvic radiation
  • * Prior androgen suppression therapy for prostate cancer for more than 6 months
  • * Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed)
  • * Prior systemic chemotherapy for prostate cancer
  • * History of proximal urethral stricture requiring dilatation
  • * Current and continuing anticoagulation with warfarin sodium (Coumadin), heparin, low-molecular weight heparin, clopidogrel bisulfate (Plavix), or equivalent (unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or place markers)
  • * Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study)
  • * Evidence of any other cancer within the past 5 years and \< 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed)
  • * History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Carlos E. Vargas, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2027-04-22