Clinical trial for Recurrent Castration-Sensitive Prostate Carcinoma
Official title Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial
ClinicalTrials.gov ID: NCT06378866
What this study is testing
What is Abiraterone?
Abiraterone is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for recurrent castration-sensitive prostate carcinoma.
Also referred to as Abiraterone acetate, CB-7598.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether adding hormone pills to radiation works better than radiation alone. It also checks if extra radiation to the pelvis stops the cancer from spreading.
- Who it's for
- You may be able to join if you have prostate cancer that has spread to other parts of your body.
- What's involved
- You would get focused radiation to your body. You might also take hormone pills to lower male hormones. Some people get extra radiation to the pelvis.
- Time commitment
- The study lasts for a set time with regular visits to check on your health.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Age ≥ 18 years
- 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 or clinically deemed non-castrate
- Prostate-specific antigen (PSA) between 0.15 and 1.5 ng/mL with PSA ≥ 0.15 ng/mL on at least two measurements at least 5 days apart
You likely can't join if
- Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the...
- Pregnant persons
- Nursing persons
- Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception
- Prior metastasis-directed therapy
- Surgery ≤ 3 weeks prior to registration
See the full eligibility criteria
- Age ≥ 18 years
- 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 or clinically deemed non-castrate
- Prostate-specific antigen (PSA) between 0.15 and 1.5 ng/mL with PSA ≥ 0.15 ng/mL on at least two measurements at least 5 days apart
- No local or metastatic recurrence apparent on advanced molecular imaging
- Serum testosterone \> 100 ng/dL or clinically deemed non-castrate
- 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) or 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 allow access 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 contraception
- Prior metastasis-directed therapy
- Surgery ≤ 3 weeks prior to registration
- Chemotherapy for prostate cancer at any time
- Androgen receptor pathway inhibitors such as abiraterone, apalutamide, darolutamide, or enzalutamide in the last 2 years
- 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 requirements
- 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...
- 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...
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Or psychiatric illness/social situations that would limit compliance with study requirements
- 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: Curatively treated non-melanotic skin cancer or papillary thyroid cancer
- 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 cancer
- History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Jacksonville, Florida, United States
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Jacksonville, Florida, United States; Rochester, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.