- Recruiting
- Treatment
- Interventional
- Randomized
- Drug & Other
- PHASE2
- Mayo Clinic
- 18 Years -
Study Purpose
This phase II trial studies the effects of stereotactic body radiation therapy (SBRT) and the timing of treatment with androgen receptor pathway inhibitor (ARPI) plus androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread from where it first started to other places in the body (metastatic), and that has come back after a period of improvement (recurrent). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Androgen can cause the growth of prostate cells. ADT lowers the amount of androgen made by the body. This may help stop the growth of tumor cells that need androgen to grow. Androgen receptor pathway inhibitors work by blocking the effects of androgen to stop the growth and spread of tumor cells. Giving SBRT alone with watchful waiting may be as effective in treating prostate cancer as giving SBRT together with ARPI and ADT.
Intervention
Procedure : Positron Emission Tomography
Drug : Prednisone
Other : Patient Observation
Drug : Abiraterone
Drug : Apalutamide
Procedure : Biospecimen Collection
Procedure : Bone Scan
Procedure : Computed Tomography
Drug : Darolutamide
Drug : Degarelix
Drug : Enzalutamide
Drug : Goserelin
Drug : Histrelin
Drug : Leuprolide
Procedure : Magnetic Resonance Imaging
Other : Questionnaire Administration
Drug : Relugolix
Radiation : Stereotactic Body Radiation Therapy
Drug : Triptorelin
Eligibility Requirements
Age ≥ 18 years
The following disease characteristics:
* Clinical confirmation of metachronous (metastatic) recurrent hormone-sensitive prostate cancer
* Five (5) or fewer metastases with at least one metastasis beyond the pelvis on advanced molecular and/or conventional imaging
* Serum testosterone \> 100ng/dL
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
Hemoglobin ≥ 8.0 g/dL (obtained ≤ 15 days prior to registration)
Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 15 days prior to registration)
Platelet count ≥ 80,000/mm\^3 (obtained ≤ 15 days prior to registration)
Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x upper limit of normal (ULN) ( ≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)
Calculated creatinine clearance ≥ 30 ml/min using the Cockcroft-Gault formula (obtained ≤ 15 days prior to registration)
Provide written informed consent
Ability to complete questionnaire(s) by themselves or with assistance
Willingness to provide mandatory blood specimens for correlative research
Willingness to provide tissue specimens for correlative research
Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown
* Pregnant persons
* Nursing persons
* Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraceptio
Prior metastasis-directed therapy
Any of the following prior therapies:
* Surgery ≤ 3 weeks prior to registration
* Chemotherapy for prostate cancer at any time
* Androgen receptor pathway inhibitor such as abiraterone, apalutamide, darolutamide, or enzalutamide in the last 2 year
Uncontrolled intercurrent non-cardiac illness including, but not limited to:
* Ongoing or active infection
* Psychiatric illness/social situations
* Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy
* Any other conditions that would limit compliance with study requirement
Receiving any other investigational agent which would be considered as a treatment for prostate cancer.
Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Uncontrolled intercurrent illness including, but not limited to:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Or psychiatric illness/social situations that would limit compliance with study requirement
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Other active malignancy ≤ 3 years prior to registration
* EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix
* NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment such as chemotherapy or antihormonal therapy for their cance
History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Recruiting status
Recruiting
Estimated enrollment
120
Study start date
Jun 03, 2024
Study end date
May 31, 2029
Last updated
Mar 23, 2025
Primary purpose
Treatment
Design
Interventional
Intervention
Drug & Other
Study phase
PHASE2
Allocation
Randomized
Sponsor:
Mayo Clinic
Collaborator:
N/A
Investigator:
Jacob J. Orme, MD, PhD
NCT06378866
Clinic | Location | Investigator | Distance | RECRUITING STATUS | Contact |
---|