Can taking drug holidays make prostate cancer treatment last longer?
NCT ID NCT02415621
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times
Summary
This study tested whether taking the drug abiraterone on an on-and-off schedule could help it work longer for men with advanced prostate cancer that no longer responds to hormone therapy. Nineteen men whose cancer had already responded to standard daily abiraterone were enrolled. The goal was to see if this adaptive approach could delay resistance and maintain quality of life.
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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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19 people
The number who actually took part.
- Started
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Apr 2015
- Finished
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Feb 2024
- 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.
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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 (the availability archival prostate tumor sample is preferred not required) * Asymptomatic or minimally symptomatic (not requiring opioids for cancer related pain) metastatic castration resistant prostate cancer (CRPC) patients on abiraterone as standard of care and achieved at least 50% decline of their pre-treatment prostatic specific antigen (PSA) * Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 * Adequate organ function * Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections or major surgery within 28 days prior to study enrollment * Prior surgical castration or concurrent use of gonadotropin-releasing hormone (GnRH) analogue (i.e. medical castration) with testosterone at screening \<50 ng/dL. * Ability to give written informed consent Exclusion Criteria: * Except GnRH analogue therapy, any other therapies for prostate cancer (excluding bisphosphonate and denosumab) must be discontinued 3 weeks before the first dose of study drugs. * Prior treatments with Cyp 17 inhibitors like TAK-700/Orteronel, ketoconazole, radium 223 or docetaxel (up to 6 cycles of docetaxel given in the non CRPC setting is allowed). Prior treatment with Sipuleucel-T is allowed. * Documented central nervous system (CNS) metastases or liver metastasis * 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. Potential participants 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: May be rescreened after adjustments of antihypertensive medications * Unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade \> 2 \[National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03\], New York Heart Association (NYHA) 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
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Other studies related to the condition(s) this trial covers.
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