De-escalated hormone therapy with radiation for prostate cancer treatment
Risk Stratified De-Escalated De-Intensified Treatment for High Risk Prostate Cancer Patients Based on Pathologic Criteria, Genetic Score, and Biologic Imaging
This study is testing whether a less intense hormone therapy combined with radiation can effectively treat high-risk prostate cancer while helping patients recover their hormonal function.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Scottsdale, Arizona) |
| Trial ID | NCT06369610 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effectiveness of risk-based de-escalated hormone therapy combined with radiation therapy in treating patients with prostate cancer. The study categorizes patients into three risk groups based on their cancer characteristics and administers varying durations of androgen deprivation therapy (ADT) alongside radiation. The primary goal is to assess the recovery of hormonal function over two years, while exploratory objectives include evaluating treatment-related toxicities, quality of life, and survival outcomes over five years. This approach aims to determine if less intensive hormone therapy can be as effective as standard treatment for high-risk prostate cancer patients.
Who should consider this trial
Good fit: Ideal candidates include men aged 18 and older with histologically confirmed high-risk prostate adenocarcinoma and specific disease characteristics.
Not a fit: Patients with previous pelvic radiation or prior long-term androgen suppression therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and less intensive treatment options for patients with high-risk prostate cancer.
How similar studies have performed: Other studies have shown promising results with risk-based treatment approaches in prostate cancer, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 (group 3 only) Exclusion Criteria: * 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
Where this trial is running
Scottsdale, Arizona
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Carlos E. Vargas, M.D. — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.