New adaptive therapy aims to outsmart prostate cancer
NCT ID NCT03511196
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests an adaptive approach to hormone therapy for men with stage IV prostate cancer that still responds to hormone treatment. Instead of a fixed schedule, the treatment is adjusted based on PSA levels. The study includes 17 participants and combines standard drugs (abiraterone and prednisone) with a GnRH agonist. The main goal is to see if men can stay on the study for at least a year without their cancer worsening.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Androgen deprivation therapy (ADT) with leuprolide, goserelin, or triptorelin, plus abiraterone and prednisone
- What this could lead to
- If successful, this could point toward a personalized treatment schedule that delays cancer progression while reducing side effects for men with advanced prostate cancer.
- What could go wrong
- This is a very early phase 1b trial with only 17 participants, so results may not apply to all patients. The adaptive approach may not improve outcomes or could lead to faster progression in some cases.
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
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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17 people
The number who actually took part.
- Started
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Sep 2018
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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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: * Histologically or cytologically confirmed adenocarcinoma of the prostate. * \>75% prostate specific antigen (PSA) decline after 12 to 16 weeks of run in period with Gonadotropin-releasing Hormone (GnRH) analog abiraterone plus prednisone. * Performance status Eastern Cooperative Oncology Group (ECOG) 0-1 * Adequate organ function Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) must be \< 2.5 x upper limit of normal (ULN), total bilirubin less than 1.5 X ULN, estimated creatinine clearance must be \>40 mL/min, absolute neutrophil count (ANC) \> 1500/l, hemoglobin above 9 g/dl, platelet count \> 100,000/l * Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections or major surgery within 28 days prior to study enrollment * Ability to give written informed consent Exclusion Criteria: * Prior GnRH analog with GnRH analogue for non-metastatic prostate cancer within 12 months prior to study enrollment or \>3 months of GnRH analog in the metastatic setting * Prior treatments with TAK-700/Orteronel, ketoconazole, apalutamide or enzalutamide. * Documented central nervous system metastases or liver metastasis * Prior surgical castration * Requiring opioids for cancer related pain. * Treatment with any investigational compound within 30 days prior to the first dose of study drugs * Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of study drugs, or previously diagnosed with another malignancy \& have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection. * Uncontrolled hypertension despite appropriate medical therapy (blood pressure of greater than 160 mmHg systolic and 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the Screening period). Note: Patients may be rescreened after adjustments of antihypertensive medications * Unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade \> 2 (NCI CTCAE, version 5), New York Association Class III or IV heart failure * Known human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C not contained with anti-viral therapy, life threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in investigator's opinion, potentially interfere with participation in this study. * Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of study drugs, including difficulty swallowing tables. * Delayed healing of wounds, ulcers, and/or bone fractures * Inability to comply with protocol requirements
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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
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H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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