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Hormone-Resistant Prostate CancerPROMOTENCT01953640

Gene Expression in Patients With Metastatic Prostate Cancer Receiving CYP-17 Inhibition Therapy

An observational study of Hormone-Resistant Prostate Cancer and Metastatic Prostate Carcinoma, run by Mayo Clinic at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research trial studies gene expression in patients with prostate cancer that has spread to other places in the body receiving cytochrome P450 17 alpha hydroxylase/17,20 lyase (CYP-17) inhibition therapy. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Laboratory Biomarker Analysis and Quality-of-Life Assessment
How many people
92 participants
Where
3 sitesUnited States
Study dates
30 May 2013to 3 Apr 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Males age > 18 years with adenocarcinoma of the prostate

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: PROstate Cancer Medically Optimized Genome Enhanced ThErapy (PROMOTE)

This research trial studies gene expression in patients with prostate cancer that has spread to other places in the body receiving cytochrome P450 17 alpha hydroxylase/17,20 lyase (CYP-17) inhibition therapy. Studying samples of tissue, blood, and urine in the laboratory from patients receiving CYP-17 inhibition therapy may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer. It may also help doctors understand how well patients respond to treatment.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine whether somatic tumor genome alterations identified in tumor tissue before or after the initiation of CYP-17 inhibition with abiraterone acetate therapy are associated with a 12-week composite progression free survival (PFS) endpoint.

II. To use tumor tissue obtained prior to the initiation of therapy and from the 12 week biopsy to develop tumor xenografts for mechanistic and functional studies which will determine whether mutations identified in the tumor genome are associated with response to drugs that target the observed mutated genes and/or associated pathways.

SECONDARY OBJECTIVES:

  1. To determine whether somatic tumor genome alterations identified before or after initiating CYP-17 inhibition with abiraterone acetate therapy are associated with overall survival.

II. To determine whether somatic tumor genome alterations identified in tumor tissue before or after the initiation of CYP-17 inhibition with abiraterone acetate therapy are associated with progression free survival (PFS).

III. To evaluate circulatory markers in blood and urine specimens for response and/or resistance to treatment. (Exploratory and correlative objectives)

OUTLINE:

Tissue, blood, and urine samples are collected at baseline and after 12-14 weeks of treatment and assessed for circulating tumor cells, genome-wide single-nucleotide polymorphism (SNP), and exome sequencing.

Being tested
Laboratory Biomarker Analysis, Quality-of-Life Assessment
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

Study groups in NCT01953640
Study groupRoleWhat they receive
Ancillary-correlative (gene expression with CYP-17 inhibition)Laboratory Biomarker Analysis: Tissue, blood, and urine samples are collected at baseline and after 12-14 weeks of treatment and assessed for circulating tumor cells, genome-wide SNP, and exome sequencing. Subjects will also receive a Quality-of-Life Assessment.
Receives: Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of PFS as defined by Prostate Cancer Working Group 2 criteria

    Measured: Up to 14 weeks

Secondary outcomes (2)

  1. Overall survival after receiving abiraterone acetate

    Kaplan-Meier curve and Cox proportional hazard regression model will be used to summarize overall survival until 5 years after abiraterone therapy in this trial.

    Measured: Up to 5 years

  2. PFS after receiving abiraterone acetate

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2013 (estimated)
  2. Study start30 May 2013
  3. Primary completion3 Dec 2015
  4. Study completion3 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01953640
Sponsor's protocol ID
MC1351
Other IDs
R01CA130908, R01CA212097, R01CA203849, W81XWH-15-1-0634, NCI-2013-01628, 13-001296, MC1351
Acronym
PROMOTE
Status last verified
Aug 2026
First submitted
26 Sep 2013
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Qin S, Liu D, Kohli M, Wang L, Vedell PT, Hillman DW, Niu N, Yu J, Weinshilboum RM, Wang L. TSPYL Family Regulates CYP17A1 and CYP3A4 Expression: Potential Mechanism Contributing to Abiraterone Response in Metastatic Castration-Resistant Prostate Cancer. Clin Pharmacol Ther. 2018 Jul;104(1):201-210. doi: 10.1002/cpt.907. Epub 2017 Nov 22.

    PubMed 29027195

  • Hart SN, Ellingson MS, Schahl K, Vedell PT, Carlson RE, Sinnwell JP, Barman P, Sicotte H, Eckel-Passow JE, Wang L, Kalari KR, Qin R, Kruisselbrink TM, Jimenez RE, Bryce AH, Tan W, Weinshilboum R, Wang L, Kohli M. Determining the frequency of pathogenic germline variants from exome sequencing in patients with castrate-resistant prostate cancer. BMJ Open. 2016 Apr 15;6(4):e010332. doi: 10.1136/bmjopen-2015-010332.

    PubMed 27084275

Questions about this trial

What is this clinical trial studying?

An observational study of Hormone-Resistant Prostate Cancer and Metastatic Prostate Carcinoma, run by Mayo Clinic at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of PFS as defined by Prostate Cancer Working Group 2 criteria (time frame: Up to 14 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01953640, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.

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