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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00070003 | Other Identifier | JHM IRB |
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To assess the safety of treating men with oligometastatic prostate cancer with the following therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of neoadjuvant androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen deprivation. Androgen blockade will be the same throughout the course of treatment.
Neoadjuvant treatment (month 1 through ~6): All patients will be treated with up to 6 months of androgen deprivation, plus up to 6 cycles of docetaxel chemotherapy. Following docetaxel therapy, patients with a prostate-specific antigen response of at least a 50% decrease from baseline, will proceed to maximum consolidative therapy.
Surgery and Radiation (month 7 though ~11): After completion of neoadjuvant therapy, the men will be treated with definitive local therapy with radical prostatectomy (RP) +/- adjuvant radiation therapy (RT). After definitive local therapy, patients will be treated with consolidative stereotactic body radiation therapy (SBRT) to the metastatic sites.
Follow up: Patients will continue on androgen deprivation for a total of 1 year. They will be followed clinically and monitored with serum testosterone and prostate-specific antigen until 2-years after completion of ADT (Androgen deprivation therapy) treatment. Androgen blockade will be the same throughout the course of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chemohormonal and definitive therapy | Experimental | (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of neoadjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leuprolide Acetate | Drug | 22.5mg by intramuscular (IM) injection every 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as Assessed by 2-year PSA Progression-free Survival Rate | To evaluate efficacy of multimodality therapy in men, defined as the 2 year PSA progression-free (PSA<0.2 ng/ml) survival among men who have non-castrate testosterone levels 2 years after enrollment. Number of participants (who have non-castrate testosterone levels 2 years after enrollment) with PSA progression-free survival. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the Multimodality Therapy as Assessed by Number of Participants With Neutropenia and Surgical or Radiation Toxicities | To assess the safety and therapeutic benefit of multimodality therapy in men presenting with newly diagnosed oligometastatic prostate cancer (<5 sites of metastases). Safety is defined as the incidence of Grades 3 and 4 neutropenia and surgical- or radiation-induced toxicities. Neutropenia is a lower than normal number of neutrophils (a type of white blood cell) in the blood. Although dependent on the specific laboratory, the normal number is of neutrophils is generally about 1500-7800 cells/microliter. Grade 3 and 4 neutropenia refer to neutrophil levels <1,000-500 and <500, respectively. The average risk of docetaxel-induced Grade 3 and 4 neutropenia is about 35%. During the course of the study, if we had seen evidence that the risk of Grade 3 and 4 neutropenia was >50%, the study would have been stopped. |
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Inclusion Criteria:
Exclusion Criteria:
Prior local therapy to treat prostate cancer (e.g. radical prostatectomy, radiation therapy, brachytherapy)
Prior therapy to a metastatic site.
Prior or ongoing systemic therapy for prostate cancer including, but not limited to:
Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.
Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
Abnormal bone marrow function [absolute neutrophil count (ANC)<1500/mm3, platelet count <100,000/mm3, hemoglobin <9 g/dL]
Abnormal liver function (bilirubin >upper limit of normal; aspartate aminotransferase , alanine aminotransferase > 2.5 x upper limit of normal)
Creatinine clearance of ≥ 30 mL/min. Creatinine clearance should be calculated suing the Cockcroft-Gault formula.
Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within previous six months.
Prior history of malignancy in the past 3 years with the exception of basal cell and squamous cell carcinoma of the skin. Other malignancies that are considered to have a low potential to progress may be enrolled at discretion of PI.
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Pienta, MD | SKCCC at Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | United States | ||
| Johns Hopkins School of Medicine - Sidney Kimmel Comprehensive Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemohormonal and Definitive Therapy | (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of neoadjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment. Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily Docetaxel: Docetaxel (taxotere) 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Prostatectomy: Removal of the entire prostate gland, plus some surrounding tissue. Radiation: 5 high dose radiation treatments to the metastatic (tumor has spread to other parts of the body) sites. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemohormonal and Definitive Therapy | (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of neoadjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment. Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily Docetaxel: Docetaxel (taxotere) 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Prostatectomy: Removal of the entire prostate gland, plus some surrounding tissue. Radiation: 5 high dose radiation treatments to the metastatic (tumor has spread to other parts of the body) sites. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Efficacy as Assessed by 2-year PSA Progression-free Survival Rate | To evaluate efficacy of multimodality therapy in men, defined as the 2 year PSA progression-free (PSA<0.2 ng/ml) survival among men who have non-castrate testosterone levels 2 years after enrollment. Number of participants (who have non-castrate testosterone levels 2 years after enrollment) with PSA progression-free survival. | Posted | Count of Participants | Participants | 2 years |
|
Up to 2 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 | Chemohormonal and Definitive Therapy | (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of neoadjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment. Leuprolide Acetate: 22.5mg by intramuscular (IM) injection every 3 months Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily Docetaxel: Docetaxel (taxotere) 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Prostatectomy: Removal of the entire prostate gland, plus some surrounding tissue. Radiation: 5 high dose radiation treatments to the metastatic (tumor has spread to other parts of the body) sites. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| back pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| edema | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Pienta | Johns Hopkins University School of Medicine | 410-502-3137 | kpienta1@jh.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 | Feb 7, 2020 | May 6, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016729 | Leuprolide |
| C053541 | bicalutamide |
| D000077143 | Docetaxel |
| D011468 | Prostatectomy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Bicalutamide | Drug | bicalutamide (Casodex) 50mg by mouth daily |
|
|
| Docetaxel | Drug | Docetaxel (taxotere) 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. |
|
|
| Prostatectomy | Procedure | Removal of the entire prostate gland, plus some surrounding tissue. |
|
|
| Radiation | Radiation | 5 high dose radiation treatments to the metastatic (tumor has spread to other parts of the body) sites. |
|
| 3 years |
| Time to Prostate-specific Antigen Recurrence | To investigate the time from an undetectable prostate-specific antigen (≤0.2 ng/mL) until the prostate-specific antigen is >0.2 over two time-points. | 3 years |
| Baltimore |
| Maryland |
| 21205 |
| United States |
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Safety of the Multimodality Therapy as Assessed by Number of Participants With Neutropenia and Surgical or Radiation Toxicities | To assess the safety and therapeutic benefit of multimodality therapy in men presenting with newly diagnosed oligometastatic prostate cancer (<5 sites of metastases). Safety is defined as the incidence of Grades 3 and 4 neutropenia and surgical- or radiation-induced toxicities. Neutropenia is a lower than normal number of neutrophils (a type of white blood cell) in the blood. Although dependent on the specific laboratory, the normal number is of neutrophils is generally about 1500-7800 cells/microliter. Grade 3 and 4 neutropenia refer to neutrophil levels <1,000-500 and <500, respectively. The average risk of docetaxel-induced Grade 3 and 4 neutropenia is about 35%. During the course of the study, if we had seen evidence that the risk of Grade 3 and 4 neutropenia was >50%, the study would have been stopped. | Posted | Count of Participants | Participants | 3 years |
|
|
|
| Secondary | Time to Prostate-specific Antigen Recurrence | To investigate the time from an undetectable prostate-specific antigen (≤0.2 ng/mL) until the prostate-specific antigen is >0.2 over two time-points. | Posted | Median | 95% Confidence Interval | Months | 3 years |
|
|
|
| 0 |
| 26 |
| 2 |
| 26 |
| 26 |
| 26 |
| abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| partial bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| neutropenic fever | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| urinary incontinence | Renal and urinary disorders | Non-systematic Assessment |
|
| bone pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| nerve pain | Nervous system disorders | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| fatigue | General disorders | Non-systematic Assessment |
|
| hot flashes | Vascular disorders | Non-systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| muscle aches | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| hematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| dysgeusia | Nervous system disorders | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| neuropathy | Nervous system disorders | Non-systematic Assessment |
|
| anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| hoarseness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| white blood cell decreased | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| blurred vision | Eye disorders | Non-systematic Assessment |
|
| insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| alkaline phosphatase increased | Investigations | Non-systematic Assessment |
|
| xerostomia | Gastrointestinal disorders | Non-systematic Assessment |
|
| pruritus | Infections and infestations | Non-systematic Assessment |
|
| tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
|
| hiccups | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| weight gain | Investigations | Non-systematic Assessment |
|
| hypertension | Vascular disorders | Non-systematic Assessment |
|
| bilirubin increased | Hepatobiliary disorders | Non-systematic Assessment |
|
| (Serum Glutamic-Oxaloacetic Transaminase)SGOT increased | Investigations | Non-systematic Assessment |
|
| (Serum Glutamic-Pyruvic Transaminase) SGPT increased | Investigations | Non-systematic Assessment |
|
| infusion reaction | General disorders | Non-systematic Assessment |
|
| floater eyes | Eye disorders | Non-systematic Assessment |
|
| decreased libido | Psychiatric disorders | Non-systematic Assessment |
|
| neutrophil count decreased | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| lymphocyte count decreased | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| stress incontinence | Psychiatric disorders | Non-systematic Assessment |
|
| intermittent dizziness | Nervous system disorders | Non-systematic Assessment |
|
| metallic taste | Nervous system disorders | Non-systematic Assessment |
|
| flushed face | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| right arm rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| (GERD)gastroesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D055585 | Physical Phenomena |