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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00241941 | Other Identifier | Johns Hopkins Institutional Review Boards |
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A single-arm, two-stage, open-label, phase 2 study investigating the safety and efficacy of intravesical gemcitabine/docetaxel for bacillus Calmette-Guerin (BCG)-naïve patients with non-muscle invasive bladder cancer (NMIBC).
All participants will receive an induction course of gemcitabine/docetaxel instillations (administered once a week for six consecutive weeks) followed by monthly maintenance instillations if initial efficacy is seen. In addition to providing initial efficacy data, this study will provide safety and long-term efficacy data on the combination regimen studied. A tolerable safety profile and demonstrated efficacy would support a potential, randomized phase 3 trial comparing the experimental combination therapy and standard of care intravesical BCG therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravesical Gemcitabine/Docetaxel | Experimental | Gemcitabine/Docetaxel induction is given intravesically in sequential order once a week for six consecutive weeks. One gram of gemcitabine in 50 ml of sterile water is slowly instilled into the bladder via a Foley catheter and the catheter is clamped for 60 minutes. The bladder is then drained and 40 mg of docetaxel in 50 ml of NSS is then slowly instilled via the Foley catheter into the bladder. The catheter is again clamped for 60 minutes before draining. If initial efficacy seen, patients will have monthly maintenance instillations of Gemcitabine/Docetaxel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | 1g gemcitabine in 50ml sterile water; instilled once weekly for 6 weeks and then once monthly for ≤ 21 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-Month Complete Response Rate | Number of patients with no evidence of recurrent high grade urothelial carcinoma of the bladder of any stage as assessed by cystoscopy with biopsy and urine cytology. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 12-Month Relapse-Free Survival Rate | Proportion of patients alive and with no evidence of recurrent high grade urothelial carcinoma of the bladder of any stage. | 12 months |
| 24-Month Relapse-Free Survival Rate |
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Inclusion Criteria:
Histologically confirmed intermediate or high-risk non-muscle invasive urothelial carcinoma of the bladder (Ta, T1, or Tis stage) on TURBT obtained within 90 days of registration defined according to modified EORTC risk criteria summarized as follows:
Low-risk tumors: Initial or recurrent tumor > 12 months after resection with all of the following:
Intermediate-risk tumors: All tumors not defined in the two adjacent categories (between the category of low- and high-risk)
High-risk tumors: Any of the following:
Note #1: Low-risk tumors as defined above are not eligible
Note #2: Mixed histologies are permitted, provided a component of urothelial carcinoma is present
Note #3: All patients with high-grade T1 (HGT1) should undergo a restaging TURBT
Eastern Cooperative Oncology Group (ECOG) (WHO) performance status 0, 1, or 2
Age ≥ 18 years old at time of consent
Evidence of post-menopausal status or negative urinary or serum pregnancy test or female pre-menopausal patients is required. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
Subjects who give a written informed consent obtained according to local guidelines.
Exclusion Criteria:
Subjects with muscle-invasive (i.e. T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma as assessed on baseline radiographic imaging obtained within 90 days prior to study registration. The required radiographic imaging includes:
Subjects with concurrent upper urinary tract (i.e. ureter, renal pelvis) urothelial carcinoma of any stage.
a. Note: Subjects with history of non-invasive (Ta, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post-treatment disease assessment (i.e. cytology, biopsy, imaging) that demonstrates no evidence of residual disease are eligible.
Subjects with another active second malignancy with an estimated overall survival from the second malignancy of < 12 months. Subjects with another second active malignancy that are deemed to have an estimated overall survival of >12 months are eligible.
Subjects who have received the last administration of an anti-cancer therapy including chemotherapy, immunotherapy, and monoclonal antibodies ≤ 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy.
Subjects who have had radiotherapy ≤ 4 weeks prior to starting study drug, or who have not recovered from radiotherapy toxicities.
Pregnant or breast-feeding women.
Subjects unwilling or unable to comply with the protocol.
Patients with prior systemic gemcitabine or docetaxel use for a non-bladder malignancy may enroll and receive treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Max Kates, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21287 | United States |
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27 subjects signed consent to be screened for eligibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravesical Gemcitabine/Docetaxel | Gemcitabine: 1g gemcitabine in 50ml sterile water; instilled once weekly for 6 weeks and then once monthly for ≤ 21 months. Docetaxel: 37.5mg docetaxel in 50ml normal saline solution (NSS); instilled once weekly for 6 weeks and then once monthly for ≤ 21 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravesical Gemcitabine/Docetaxel | Gemcitabine: 1g gemcitabine in 50ml sterile water; instilled once weekly for 6 weeks and then once monthly for ≤ 21 months. Docetaxel: 37.5mg docetaxel in 50ml normal saline solution (NSS); instilled once weekly for 6 weeks and then once monthly for ≤ 21 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 3-Month Complete Response Rate | Number of patients with no evidence of recurrent high grade urothelial carcinoma of the bladder of any stage as assessed by cystoscopy with biopsy and urine cytology. | 1 patient withdrew consent and data was not collected. | Posted | Count of Participants | Participants | 3 months |
|
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravesical Gemcitabine/Docetaxel | Gemcitabine: 1g gemcitabine in 50ml sterile water; instilled once weekly for 6 weeks and then once monthly for ≤ 21 months. Docetaxel: 37.5mg docetaxel in 50ml normal saline solution (NSS); instilled once weekly for 6 weeks and then once monthly for ≤ 21 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Max Kates, MD | Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | 4105028130 | mkates@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 25, 2023 | Aug 9, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D000093284 | Non-Muscle Invasive Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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|
| Docetaxel | Drug | 37.5mg docetaxel in 50ml normal saline solution (NSS); instilled once weekly for 6 weeks and then once monthly for ≤ 21 months. |
|
|
Proportion of patients alive and with no evidence of recurrent high grade urothelial carcinoma of the bladder of any stage.
| 24 months |
| Safety Profile as Assessed by Proportion of Adverse Events by Type | Proportion of adverse events by type, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). | Up to 24 months |
| Safety Profile as Assessed by Proportion of Adverse Events by Grade | Proportion of adverse events by grade, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). | Up to 24 months |
| Number of Gene Alterations as Measured by RNA-seq | Number of gene alterations as measured by RNA-seq. Compare results to 3-month Complete Response rate using statistical methods. | 3 months |
| Type of Gene Alterations as Measured by RNA-seq | Type of gene alterations as measured by RNA-seq. Compare results to 3-month Complete Response rate using statistical methods. | 3 months |
| Number of Gene Alterations as Measured by RNA-seq | Number of gene alterations as measured by RNA-seq. Compare results to 12-month Relapse-Free Survival rate using statistical methods. | 12 months |
| Type of Gene Alterations as Measured by RNA-seq | Type of gene alterations as measured by RNA-seq. Compare results to 12-month Relapse-Free Survival rate using statistical methods. | 12 months |
| Number of DNA Mutations as Measured by Whole Transcriptome | Number of DNA mutations as measured by whole transcriptome. Compare results to 3-month Complete Response rate. | 3 months |
| Number of DNA Mutations as Measured by Whole Exome | Number of DNA mutations as measured by whole exome. Compare results to 3-month Complete Response rate. | 3 months |
| Number of DNA Mutations as Measured by Panel DNA Sequencing | Number of DNA mutations as measured by panel DNA sequencing. Compare results to 3-month Complete Response rate. | 3 months |
| Type of DNA Mutations as Measured by Whole Transcriptome | Type of DNA mutations as measured by whole transcriptome. Compare results to 3-month Complete Response rate. | 3 months |
| Type of DNA Mutations as Measured by Whole Exome | Type of DNA mutations as measured by whole exome. Compare results to 3-month Complete Response rate. | 3 months |
| Type of DNA Mutations as Measured by Panel DNA Sequencing | Type of DNA mutations as measured by panel DNA sequencing. Compare results to 3-month Complete Response rate. | 3 months |
| Number of DNA Mutations as Measured by Whole Transcriptome | Number of DNA mutations as measured by whole transcriptome. Compare results to 12-month Relapse Free Survival rate using statistical analysis. | 12 months |
| Number of DNA Mutations as Measured by Whole Exome | Number of DNA mutations as measured by whole exome. Compare results to 12-month Relapse Free Survival rate using statistical analysis. | 12 months |
| Number of DNA Mutations as Measured by Panel DNA Sequencing | Number of DNA mutations as measured by panel DNA sequencing. Compare results to 12-month Relapse Free Survival rate using statistical analysis. | 12 months |
| Type of DNA Mutations as Measured by Whole Transcriptome | Type of DNA mutations as measured by whole transcriptome. Compare results to 12-month Relapse Free Survival rate using statistical analysis. | 12 months |
| Type of DNA Mutations as Measured by Whole Exome | Type of DNA mutations as measured by whole exome. Compare results to 12-month Relapse Free Survival rate using statistical analysis. | 12 months |
| Type of DNA Mutations as Measured by Panel DNA Sequencing | Type of DNA mutations as measured by panel DNA sequencing. Compare results to 12-month Relapse Free Survival rate using statistical analysis. | 12 months |
| Numbers of T-cell Subpopulations | Numbers of t-cell subpopulations utilizing immunohistochemical (IHC) staining and flow cytometry. Compare results to 3-month Complete Response rate using statistical analysis. | 3 months |
| Ratio of T-cell Subpopulations | Ratio of t-cell subpopulations utilizing IHC staining and flow cytometry. Compare results to 3-month Complete Response rate using statistical analysis. | 3 months |
| Numbers of T-cell Subpopulations | Numbers of t-cell subpopulations utilizing IHC staining and flow cytometry. Compare results to 12-month Relapse-Free Survival rate using statistical analysis. | 12-months |
| Ratio of T-cell Subpopulations | Ratio of t-cell subpopulations utilizing IHC staining and flow cytometry. Compare results to 12-month Relapse-Free Survival rate using statistical analysis. | 12-months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Pre-trial pathologic stage | High-grade (HG) bladder cancer is described as more likely to grow and spread after treatment.T1 is defined as cancer that has grown into the layer of connective tissue under the lining layer of the bladder, but has not reached the layer of muscle in the bladder wall.vCIS is defined as cancer that is flat.Ta is defined as cancer that has grown toward the hollow center of the bladder but has not grown into the connective tissue or muscle of the bladder wall (non-invasive papillary carcinoma). Pathologic staging order of better to worse prognosis: HGTa, CIS, HGT1 without CIS, and HGT1 with CIS. | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | 12-Month Relapse-Free Survival Rate | Proportion of patients alive and with no evidence of recurrent high grade urothelial carcinoma of the bladder of any stage. | Not Posted | 12 months | Participants |
| Secondary | 24-Month Relapse-Free Survival Rate | Proportion of patients alive and with no evidence of recurrent high grade urothelial carcinoma of the bladder of any stage. | Not Posted | 24 months | Participants |
| Secondary | Safety Profile as Assessed by Proportion of Adverse Events by Type | Proportion of adverse events by type, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). | Not Posted | Up to 24 months | Participants |
| Secondary | Safety Profile as Assessed by Proportion of Adverse Events by Grade | Proportion of adverse events by grade, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). | Not Posted | Up to 24 months | Participants |
| Secondary | Number of Gene Alterations as Measured by RNA-seq | Number of gene alterations as measured by RNA-seq. Compare results to 3-month Complete Response rate using statistical methods. | Not Posted | 3 months | Participants |
| Secondary | Type of Gene Alterations as Measured by RNA-seq | Type of gene alterations as measured by RNA-seq. Compare results to 3-month Complete Response rate using statistical methods. | Not Posted | 3 months | Participants |
| Secondary | Number of Gene Alterations as Measured by RNA-seq | Number of gene alterations as measured by RNA-seq. Compare results to 12-month Relapse-Free Survival rate using statistical methods. | Not Posted | 12 months | Participants |
| Secondary | Type of Gene Alterations as Measured by RNA-seq | Type of gene alterations as measured by RNA-seq. Compare results to 12-month Relapse-Free Survival rate using statistical methods. | Not Posted | 12 months | Participants |
| Secondary | Number of DNA Mutations as Measured by Whole Transcriptome | Number of DNA mutations as measured by whole transcriptome. Compare results to 3-month Complete Response rate. | Not Posted | 3 months | Participants |
| Secondary | Number of DNA Mutations as Measured by Whole Exome | Number of DNA mutations as measured by whole exome. Compare results to 3-month Complete Response rate. | Not Posted | 3 months | Participants |
| Secondary | Number of DNA Mutations as Measured by Panel DNA Sequencing | Number of DNA mutations as measured by panel DNA sequencing. Compare results to 3-month Complete Response rate. | Not Posted | 3 months | Participants |
| Secondary | Type of DNA Mutations as Measured by Whole Transcriptome | Type of DNA mutations as measured by whole transcriptome. Compare results to 3-month Complete Response rate. | Not Posted | 3 months | Participants |
| Secondary | Type of DNA Mutations as Measured by Whole Exome | Type of DNA mutations as measured by whole exome. Compare results to 3-month Complete Response rate. | Not Posted | 3 months | Participants |
| Secondary | Type of DNA Mutations as Measured by Panel DNA Sequencing | Type of DNA mutations as measured by panel DNA sequencing. Compare results to 3-month Complete Response rate. | Not Posted | 3 months | Participants |
| Secondary | Number of DNA Mutations as Measured by Whole Transcriptome | Number of DNA mutations as measured by whole transcriptome. Compare results to 12-month Relapse Free Survival rate using statistical analysis. | Not Posted | 12 months | Participants |
| Secondary | Number of DNA Mutations as Measured by Whole Exome | Number of DNA mutations as measured by whole exome. Compare results to 12-month Relapse Free Survival rate using statistical analysis. | Not Posted | 12 months | Participants |
| Secondary | Number of DNA Mutations as Measured by Panel DNA Sequencing | Number of DNA mutations as measured by panel DNA sequencing. Compare results to 12-month Relapse Free Survival rate using statistical analysis. | Not Posted | 12 months | Participants |
| Secondary | Type of DNA Mutations as Measured by Whole Transcriptome | Type of DNA mutations as measured by whole transcriptome. Compare results to 12-month Relapse Free Survival rate using statistical analysis. | Not Posted | 12 months | Participants |
| Secondary | Type of DNA Mutations as Measured by Whole Exome | Type of DNA mutations as measured by whole exome. Compare results to 12-month Relapse Free Survival rate using statistical analysis. | Not Posted | 12 months | Participants |
| Secondary | Type of DNA Mutations as Measured by Panel DNA Sequencing | Type of DNA mutations as measured by panel DNA sequencing. Compare results to 12-month Relapse Free Survival rate using statistical analysis. | Not Posted | 12 months | Participants |
| Secondary | Numbers of T-cell Subpopulations | Numbers of t-cell subpopulations utilizing immunohistochemical (IHC) staining and flow cytometry. Compare results to 3-month Complete Response rate using statistical analysis. | Not Posted | 3 months | Participants |
| Secondary | Ratio of T-cell Subpopulations | Ratio of t-cell subpopulations utilizing IHC staining and flow cytometry. Compare results to 3-month Complete Response rate using statistical analysis. | Not Posted | 3 months | Participants |
| Secondary | Numbers of T-cell Subpopulations | Numbers of t-cell subpopulations utilizing IHC staining and flow cytometry. Compare results to 12-month Relapse-Free Survival rate using statistical analysis. | Not Posted | 12-months | Participants |
| Secondary | Ratio of T-cell Subpopulations | Ratio of t-cell subpopulations utilizing IHC staining and flow cytometry. Compare results to 12-month Relapse-Free Survival rate using statistical analysis. | Not Posted | 12-months | Participants |
| 0 |
| 26 |
| 2 |
| 26 |
| 23 |
| 26 |
| Infections and infestations - Other, COVID-19 | Infections and infestations | Non-systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Bladder infection | Infections and infestations | Non-systematic Assessment |
|
| Bladder spasm | Renal and urinary disorders | Non-systematic Assessment |
|
| Blurred vision | Eye disorders | Non-systematic Assessment |
|
| Chills | General disorders | Non-systematic Assessment |
|
| Confusion | Psychiatric disorders | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Malaise | General disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Dyspareunia | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Eye disorders - Other, Meibomian gland dysfunction | Eye disorders | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Fever | General disorders | Non-systematic Assessment |
|
| Gait disturbance | General disorders | Non-systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Infections and infestations - Other, COVID-19 | Infections and infestations | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | Non-systematic Assessment |
|
| Metabolism and nutrition disorders - Other, Type II Diabetes | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Nervous system disorders - Other, Parkinson's disease | Nervous system disorders | Non-systematic Assessment |
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| Pain | General disorders | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Platelet count decreased | Investigations | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Renal and urinary disorders - Other, lower urinary tract symptoms | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal and urinary disorders - Other, docetaxel retention | Renal and urinary disorders | Non-systematic Assessment |
|
| Reproductive system and breast disorders - Other, right breast tenderness | Reproductive system and breast disorders | Non-systematic Assessment |
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| Retinopathy | Eye disorders | Non-systematic Assessment |
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| Syncope | Nervous system disorders | Non-systematic Assessment |
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| Tremor | Nervous system disorders | Non-systematic Assessment |
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| Urinary frequency | Renal and urinary disorders | Non-systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
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| Urinary urgency | Renal and urinary disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |