New combo therapy aims to halt spread of prostate cancer
NCT ID NCT04748042
First seen Jun 24, 2026 · Last updated Jul 14, 2026 · Updated 4 times
Summary
This phase 2 study tests a combination of radiation, hormone therapy (ADT), and two drugs (abiraterone and olaparib) in 21 men with prostate cancer that has spread to a few spots in the body. The goal is to see if this approach can prevent the cancer from growing or spreading further. Participants receive treatment for about 6 months and are followed for 24 months to check for treatment failure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Abiraterone, Olaparib, Androgen Deprivation Therapy (ADT), and radiation therapy
- What this could lead to
- If successful, this combination could offer a new way to control prostate cancer that has spread to a few areas, potentially delaying further progression.
- What could go wrong
- This is a small, early-phase study with only 21 participants, so results may not apply to everyone. The treatment combines multiple drugs with side effects, and it is not yet known if it works better than standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
21 people
The number who actually took part.
- Started
-
May 2021
- Expected to finish
-
May 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologic or cytologic diagnosis of prostate adenocarcinoma (pure small cell or pure neuroendocrine prostate cancer are not allowed). * Prior radical prostatectomy OR external beam radiation with curative intent (e.g. HiFU or partial gland therapies are not acceptable) delivered to prostate. Patients with prior radical prostatectomy with positive margins must have undergone salvage or adjuvant radiation. * Have newly diagnosed oligometastatic prostate cancer based on molecular imaging (e.g. 68Ga-PSMA PET/CT or Axumin, excludes FDG-PET). Oligometastatic prostate cancer is between 1 and ≤ 5 radiation treatment sites. A site can be up to 5 cm and contain multiple lesions. * Newly diagnosed oligometastatic disease requires that no prior image guided radiation was given to sites outside of the prostate bed or pelvic lymph nodes that are typically treated in the salvage or adjuvant radiation setting. * Patients must have a PSA \>0.2 ng/mL (confirmed ≥4 weeks later with subsequent rise) for those who underwent radical prostatectomy. For those with prior curative radiotherapy, they must meet the Phoenix criteria for progression (nadir of PSA + 2 ng/mL) * Medically fit for radiotherapy * All molecular positive disease is within an anatomic distribution that (in the view of the radiation oncologist) can be treated safely per standard radiation oncology principles * Candidate for androgen deprivation therapy (e.g. leuprolide, goserelin, degarelix) abiraterone therapy (financial and medical) in view of medical oncology using package insert for guidance * Patient must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined per protocol * Androgen deprivation therapy with or without second generation androgen receptor inhibitors or abiraterone (when given to optimize focal therapies like surgery or radiation) in the curative setting are allowed as long as testosterone has recovered to above 150 ng/dL. * Androgen deprivation therapy (with or without second generation androgen receptor inhibitors or abiraterone) for metastatic disease is allowed up to 4 weeks prior to registration. If previous ADT was used in curative setting, testosterone recovery must be documented (testosterone \>150 ng/dL) OR \>1 year elapsed from last administration of curative attempt ADT before recent ADT was resumed. * ECOG ≤1 * Patients must use a condom during treatment and for 6 months after the last dose of olaparib or abiraterone when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of childbearing potential of patients on study should also use a highly effective form of contraception. * Capable of giving signed informed consent Exclusion Criteria: * Prior orchiectomy * Prior exposure to PARP inhibitors, docetaxel or cabazitaxel. * Has a known additional malignancy within the past 3 years that has required treatment excluding superficial squamous skin cancer or carcinoma in situ of bladder or head and neck (those are permissible). * Life expectancy ≤3 years in view of treating provider * Presence of known parenchymal brain metastasis (imaging not required in absence of symptoms) * Symptoms of cord compression requiring immediate radiation. * Patients with myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or with features suggestive of MDS/AML per primary provider * Severe hepatic impairment (Child-Pugh Class C) * Patients with known active hepatitis infection (e.g. hepatitis B, or C) * Concurrent use of strong CYP3A inducers (e.g. phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, nevirapine, St. John's Wort) or moderate inducers (e.g bosentan, efavirenz or modafinil). The required washout period prior to starting olaparib is 5 weeks for phenobarbital or enzlautamide and 3 weeks for other agents. The washout requirement is measured from anticipated start of Olaparib, NOT from start of study. * Concomitant use of known strong CYP3A inhibitors (e.g. intraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boveprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks. The washout requirement is measured from anticipated start of olaparib, NOT from start of study. * Major surgery within 2 weeks of starting study treatment and patient must have recovered from any effects of any major surgery * Clinically significant cardiovascular disease as evidenced by: * myocardial infarction or arterial thrombotic events (e.g. stroke) in the past 6 months * resting EKG indicating uncontrolled, potentially reversible cardiac candiation, as judged by the investigator (e.g. unstable ischemia, uncontrolled symptomatic arrhythmia, QTc Fridericia prolongation \>500 ms) or patients with congenital long QT syndrome * severe or unstable angina, uncontrolled atrial fibrillation (controlled atrial fibrillation is allowed) or other (non-atrial fibrillation) cardiac arrhythmia requiring therapy * Active New York Heart Association Class II-IV heart failure * if any prior history of CHF (regardless of New York Heart Association assignment), a cardiac ejection fraction measurement (by echocardiography or multigated acquisition scan) is required within 6 months and mush not be \<50%. * Planned or scheduled cardiac surgery or percutaneous coronary intervention procedure * Prior revascularization procedure (coronary, carotid or peripheral artery stenosis) within the past 12 months * History of uncontrolled pituitary or adrenal dysfunction * Active infection or other medical condition that would make prednisone use contraindicated * Any chronic medical condition requiring a systemic dose of corticosteroid \>10 mg prednisone daily * Prior allogeneic bone marrow transplant or double umbilical cord blood transplantation * Participation in another clinical study with an investigational product or investigational medical devices within 1 month of registration * Involvement in the planning and/or conduct of the study (applies to both AstraZeneca and Merck staff and/or staff at the University of Michigan). * Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements. * Uncontrolled hypertension (systolic blood pressure ≥160 mmHg) of diastolic blood pressure ≥95 mmHg. Patients with documented white coat syndrome (with home blood pressure machine compared to office for calibration) are allowed if home blood pressure measured daily for a week meet eligibility * Known hypersensitivity to olaparib, abiraterone, planned ADT agent (e.g. leuprolide, goserelin, degarelix), any of the excipients of any of these agents (olaparib, abiraterone, planned ADT agent) or drugs with a similar chemical structure to them or class to agents (olaparib, abiraterone or planned ADT) * Immunocompromised patients * Patients who are considered a poor medical risk due to a serious uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples not discussed elsewhere include, but are not limited to uncontrolled seizure disorder, superior vena cava syndrome or any psychiatric disorder that prohibits informed consent * Persistent toxicities (CTCAE Grade ≥2) caused by previous cancer therapy, excluding alopecia or sensory peripheral neuropathy * Patients who are unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Castrate sensitive prostate cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Radioactive missile aims at prostate cancer that spread
- New PET tracer targets ACP3 to spot prostate cancer
- Can a One-Week radiation course match four weeks for prostate cancer?
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains