Scientists hunt for genetic clues in advanced prostate cancer

NCT ID NCT01953640

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study looks at genes in men with advanced prostate cancer that has spread and is no longer responding to hormone therapy. Researchers will analyze tissue, blood, and urine samples from 92 patients receiving a drug called abiraterone. The goal is to find genetic changes that may help predict how well patients respond to treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help identify genetic markers that predict how well prostate cancer patients respond to CYP-17 inhibition therapy.
What could go wrong
This is an observational study focused on lab analysis, not a treatment trial. It may not lead to direct patient benefits.

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.

Participants

92 people

The number who actually took part.

Started

May 2013

Finished

Apr 2023

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.

Who is studied

Males age \> 18 years with adenocarcinoma of the prostate

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histological diagnosis of adenocarcinoma of the prostate or documented history in medical records of having received treatment for prostate cancer diagnosis * Metastatic disease on chest, abdominal, or pelvic computed tomography (CT) and/or bone scan amenable to biopsy * Hemoglobin (HgB) \> 9.0 gm * Absolute neutrophil count (ANC) \>= 1500 cells/L * Platelets \>= 100,000 u/L * Creatinine =\< 1.5 x upper limit of normal (ULN) * Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase (AST)) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase (ALT)) =\< 1.5 x ULN * Castrate serum testosterone level (\< 50 ng/dL -or- \< 1.7 nmol/L) * Progression while on or after androgen deprivation therapy defined as: * Progressive measurable disease: at least a 20% increase in the sum of the longest diameters of measurable lesions over the smallest sum observed or the appearance of one or more new lesions as assessed by imaging during hormone ablation treatment; measurable lesions are nodal or visceral soft-tissue lesions with nodal lesions \>= 20 mm in diameter or visceral/soft-tissue lesions \>= 10 mm in diameter OR * Bone scan progression: appearance of 2 or more new lesions on bone scan during hormone ablation treatment OR * Increasing serum prostate-specific antigen (PSA) level: two consecutive increases in PSA levels documented over a previous reference value obtained at least one week apart are required; if the third PSA value is less than the second, an additional fourth test to confirm a rising PSA is acceptable; a minimum starting value of 2.0 ng/mL is required for study enrollment * Note: androgen deprivation therapy may have included either medical or surgical castration * \>= 14 days has passed since completing radiotherapy (exception for radiotherapy: \>= 7 days since completing a single fraction of =\< 800 centigray (cGy) to a restricted field or limited-field radiotherapy to non-marrow bearing area such as an extremity or orbit) at the time of registration * Patients who may have received systemic chemotherapy or any novel therapeutic CYP-17 inhibitor and/or novel androgen receptor (AR) inhibitor agents previously for prostate cancer should have received the last dose of the previously administered systemic therapy \>= 12 months from the date of registration * Provide informed written consent * Has recovered from any other therapy-related toxicity to =\< grade 2, (except alopecia, anemia and any signs or symptoms of androgen deprivation therapy) * Willing to provide tissue and blood samples for correlative research purposes * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 * Patient is considered a candidate for initiating CYP-17 inhibitors abiraterone acetate and prednisone after failure of hormonal therapy and has no contra-indication to starting this combination as standard of care * Patients have stopped any antiandrogen therapy (including bicalutamide) \>= 4 weeks prior to first dose of study drug; in addition any other therapies for prostate cancer, other than gonadotropin-releasing hormone (GnRH) analogue therapy, such as progesterone, medroxyprogesterone, progestins (megestrol), or 5-alpha reductase inhibitors (e.g., finasteride or dutasteride), must be discontinued \>= 2 weeks before the first dose of study drug Exclusion Criteria: * Use of any of these therapies =\< 12 months prior to registration: * Use of any of the standard therapies for castrate resistant prostate cancer (CRPC) stage =\< 12 months prior to registration; Note: see below for further exclusion details of specific standard therapies * Initiation of full dose chemotherapy with docetaxel for CRPC stage =\< 12 months prior to registration is an exclusion criterion * Note: docetaxel for hormone sensitive prostate cancer is not an exclusion criterion * Use of radium-223 for CRPC stage is an exclusion criteria * Use of Provenge vaccine for CRPC =\< 12 months prior to registration is an exclusion criterion * Note: less than 3 doses of Provenge vaccine =\< 12 months prior to registration for CRPC is not an exclusion criterion * Initiation of full dose chemotherapy with mitoxantrone for CRPC stage with-in the previous 12 months is an exclusion criterion * Use of cabazitaxel chemotherapy =\< 12 months prior to registration is an exclusion criterion * Note: initiation of full dose chemotherapy with cabazitaxel for CRPC stage with-in the previous 12 months is an exclusion criterion * Use of ketoconazole with steroids =\< 12 months prior to registration for CRPC stage * Note: ketoconazole therapy taken for a time period of =\< 12 weeks in the 12 month period prior to registration is not an exclusion criterion * Use of enzalutamide for CRPC stage =\< 12 months prior to registration is an exclusion criteria use of any experimental or standard of care CYP-17 inhibitors =\< 12 months prior to registration is an exclusion criteria * Note: standard of care CRPC therapy with a CYP-17 inhibitor =\< 7 days prior to registration is not an exclusion criterion; if taken for 8 days or more it will be counted as an exclusion criterion * Receiving any intermittent hormonal treatment GnRH analogues and has not yet achieved sub-castrate levels of testosterone (\< 50 ng/dl or \< 1.7 mmol/L) * History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated; Note: brain imaging for asymptomatic patients is not required * Current symptomatic cord compression requiring surgery or radiation therapy * Note: once successfully treated and there has been no progression, patients are eligible for the study * Active second malignancy (except non-melanomatous skin or superficial bladder cancer) defined as requiring anticancer therapy or at high risk of recurrence during the study * Uncontrolled medical conditions such as heart failure, myocardial infarction, uncontrolled hypertension, disseminated on-going coagulopathy, stroke or treatment of a major active infection =\< 3 months of registration, as well as any significant concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy * Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device * Note: concomitant participation in observational studies is acceptable * Patients with a global or severe deterioration of health status such that it requires discontinuation of standard of care treatments for CRPC stage without evidence of disease progression =\< 12 weeks prior to registration

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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

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980, United States

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