A Study of Definitive Therapy to Treat Prostate Cancer (oligo-mets)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02716974|
Recruitment Status : Active, not recruiting
First Posted : March 23, 2016
Last Update Posted : December 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Leuprolide Acetate Drug: Bicalutamide Drug: Docetaxel Procedure: Prostatectomy Radiation: Radiation||Phase 2|
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.
Local consolidation (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.
Systemic consolidation: 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 systemic consolidation. Androgen blockade will be the same throughout the course of treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Definitive Therapy for Newly Diagnosed Men With Oligometastatic Prostate Cancer|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2024|
Experimental: 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.
Drug: Leuprolide Acetate
22.5mg by intramuscular (IM) injection every 3 months
Other Name: Lupron Deport
bicalutamide (Casodex) 50mg by mouth daily
Other Name: Casodex
Docetaxel (taxotere) 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles.
Other Name: Texotere
Removal of the entire prostate gland, plus some surrounding tissue.
Other Name: Radical prostatectomy
5 high dose radiation treatments to the metastatic (tumor has spread to other parts of the body) sites.
- Safety of the multimodality therapy [ Time Frame: 3 years ]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.
- Two-year Undetectable prostate-specific antigen [ Time Frame: 2 years ]To investigate the total number and the percentage of men with an undetectable Prostate-Specific Antigen at 2 years after study enrollment.
- Time to prostate-specific antigen recurrence [ Time Frame: 3 years ]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.
- Time to castrate resistant prostate cancer [ Time Frame: 3 years ]To investigate the interval between study enrollment and the date of documented clinical or serological progression with testosterone less than 50 ng/dL.
- Overall survival [ Time Frame: 5 years ]To measure the period from study enrollment until death from any cause.
- Quality of life-Functional Assessment of Cancer Therapy-Prostate (FACT-P) [ Time Frame: 3 years ]The FACT-P measures quality of life related to prostate cancer.
- Quality of life-Functional Assessment of Cancer Therapy-Taxane (FACT-T) [ Time Frame: 3 years ]The FACT-taxane measures quality of life related to chemotherapy treatment.
- The time interval from completion of treatment on study until the first chemotherapy. [ Time Frame: 3 years ]To investigate the time from end of androgen deprivation (or last treatment on study) until the time-point when chemotherapy is given off-study.
- The time interval from completion of treatment on study until the first androgen deprivation therapy. [ Time Frame: 3 years ]To investigate the time from end of androgen deprivation until the time-point when androgen deprivation is given off-study.
- The time interval from completion of treatment on study until any new metastases. [ Time Frame: 3 years ]To investigate the time from end of androgen deprivation until the time-point when a new metastasis is demonstrated on imaging (CT scan, bone scan, or positron emission tomography scan).
- The location of first distant metastatic progression [ Time Frame: 3 years ]To investigate the time from end of androgen deprivation until the time-point when a new metastasis, outside of the pelvis, is demonstrated on imaging (CT scan, bone scan, or positron emission tomography scan).
- 5 years overall survival [ Time Frame: 5 years ]Improved 5-yr overall survival as compared to 5-yr overall survival in men with metastatic prostate. cancer included in the Surveillance Epidemiology End Results Program database
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716974
|United States, District of Columbia|
|Sibley Memorial Hospital|
|Washington, District of Columbia, United States, 20016|
|United States, Maryland|
|Johns Hopkins School of Medicine - Sidney Kimmel Comprehensive Cancer Center|
|Baltimore, Maryland, United States, 21205|
|Johns Hopkins Bayview Medical Center|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Kenneth Pienta, MD||SKCCC at Johns Hopkins University|