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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00120414 | Other Identifier | JHU 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 adjuvant androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years of androgen deprivation. Androgen blockade will be the same throughout the course of treatment.
Adjuvant 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.
Radiation (month 7 though ~11): After completion of adjuvant chemotherapy, the men will be treated with definitive local therapy with adjuvant radiation therapy (RT). After definitive local therapy, patients will be treated with consolidative stereotactic body radiation therapy (SBRT) to the metastatic sites (if present).
Follow up: Patients will continue on androgen deprivation for a total of 2 years. 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 after prostatectomy | Experimental | (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of adjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years 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 3-year Prostate-specific Antigen Progression-free Survival Rate | To evaluate efficacy of multimodality therapy in men, defined as the 3 year Prostate-specific antigen progression-free (Prostate-specific antigen<0.2 ng/ml) survival rate among men who have non-castrate testosterone levels 2 years after enrollment. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the 3 Years Multimodality Therapy Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4 Criteria and the Clavien-Dindo Classification | To assess the safety of multimodality therapy in men presenting with newly diagnosed oligometastatic prostate cancer after prostatectomy. Toxicities related to neoadjuvant therapy, radiation therapy, or stereotactic body radiation therapy (SBRT) will be assessed using CTCAE version 4 criteria. Surgical toxicities will be assessed using the Clavien-Dindo Classification |
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Inclusion Criteria:
Exclusion Criteria:
Prior local non-surgical therapy to treat prostate cancer (e.g. 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 >ULN ( upper limit of normal); AST (aspartate aminotransferase), ALT (alanine transaminase) > 2.5 x upper limit of normal)
Creatinine clearance of ≥ 30 mL/min. CrCl (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 |
|---|---|---|---|---|---|---|
| Johns Hopkins Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemohormonal and Definitive Therapy After Prostatectomy | (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of adjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years 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 Docetaxel: 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2. Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily Radiation: Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions. Abiraterone Acetate: Abiraterone acetate 1000 mg / day may be given at the investigator's discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemohormonal and Definitive Therapy After Prostatectomy | (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of adjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years 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 Docetaxel: 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2. Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily Radiation: Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions. Abiraterone Acetate: Abiraterone acetate 1000 mg / day may be given at the investigator's discretion. |
| 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 | Efficacy as Assessed by 3-year Prostate-specific Antigen Progression-free Survival Rate | To evaluate efficacy of multimodality therapy in men, defined as the 3 year Prostate-specific antigen progression-free (Prostate-specific antigen<0.2 ng/ml) survival rate among men who have non-castrate testosterone levels 2 years after enrollment. | Assessed 25/26 patients (1 patient withdrew from study prior completing TED) | Posted | Count of Participants | Participants | 3 years |
|
Up to 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 | Chemohormonal and Definitive Therapy After Prostatectomy | (1st) Systemic chemo-hormonal therapy with up to 6-months (~24 weeks) of adjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 2 years 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 Docetaxel: 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2. Bicalutamide: bicalutamide (Casodex) 50mg by mouth daily Radiation: Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions. Abiraterone Acetate: Abiraterone acetate 1000 mg / day may be given at the investigator's discretion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fatigue | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Pienta | Johns Hopkins University | 4105023137 | 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 | Sep 21, 2020 | Dec 20, 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 |
| D000077143 | Docetaxel |
| C053541 | bicalutamide |
| D011827 | Radiation |
| D000069501 | Abiraterone Acetate |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Docetaxel | Drug | 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2. |
|
|
| Bicalutamide | Drug | bicalutamide (Casodex) 50mg by mouth daily |
|
|
| Radiation | Radiation | Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions. |
|
| Abiraterone Acetate | Drug | Abiraterone acetate 1000 mg / day may be given at the investigator's discretion. |
|
|
| 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 |
| The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Baltimore |
| Maryland |
| 21231 |
| United States |
| Participants |
|
| Age, Continuous | Median | Full Range | 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 3 Years Multimodality Therapy Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4 Criteria and the Clavien-Dindo Classification | To assess the safety of multimodality therapy in men presenting with newly diagnosed oligometastatic prostate cancer after prostatectomy. Toxicities related to neoadjuvant therapy, radiation therapy, or stereotactic body radiation therapy (SBRT) will be assessed using CTCAE version 4 criteria. Surgical toxicities will be assessed using the Clavien-Dindo Classification | Assessed all patients, from time of enrollment until study exit/3 years from enrollment. | 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. | Assessed 25/26 patients (1 patient withdrew from study prior completing TED) | Posted | Median | 95% Confidence Interval | Month | 3 years |
|
|
|
| 0 |
| 26 |
| 2 |
| 26 |
| 26 |
| 26 |
| neutropenic fever | General disorders | Non-systematic Assessment |
|
| hot flashes | Vascular disorders | Non-systematic Assessment |
|
| neuropathy | Nervous system disorders | Non-systematic Assessment |
|
| alopecia; | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| dysgeusia | Nervous system disorders | Non-systematic Assessment |
|
| hiccups | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| skin alterations | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| xerosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| edema (lower extremity) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| gastritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| gastrointestinal reflux | Gastrointestinal disorders | Non-systematic Assessment |
|
| pain (bilateral legs) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| mucositis | Gastrointestinal disorders | Non-systematic Assessment |
|
| pain (joint); | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| nail ridging | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| weight gain | Investigations | Non-systematic Assessment |
|
| hematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| urinary tract obstruction | Renal and urinary disorders | Non-systematic Assessment |
|
| oral candidiasis | Gastrointestinal disorders | Non-systematic Assessment |
|
| insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| depression | Psychiatric disorders | Non-systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| pain (pelvis) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| memory impairment | Nervous system disorders | Non-systematic Assessment |
|
| heartburn | Gastrointestinal disorders | Non-systematic Assessment |
|
| elevated ALT | Investigations | Non-systematic Assessment |
|
| elevated AST | Investigations | Non-systematic Assessment |
|
| hematochezia | Gastrointestinal disorders | Non-systematic Assessment |
|
| xerostomia | Gastrointestinal disorders | Non-systematic Assessment |
|
| anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| general body aches | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| pruritis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| epistaxis | Investigations | Non-systematic Assessment |
|
| infusion related reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| nail discoloration | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| fever | General disorders | Non-systematic Assessment |
|
| diarrhea | 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 |
| D055585 | Physical Phenomena |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |