A Study of Definitive Therapy to Treat Prostate Cancer (oligo-mets)
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|ClinicalTrials.gov Identifier: NCT02716974|
Recruitment Status : Completed
First Posted : March 23, 2016
Results First Posted : August 4, 2022
Last Update Posted : August 4, 2022
|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.
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.
|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|
|Actual Primary Completion Date :||April 2022|
|Actual Study Completion Date :||April 2022|
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.
- Efficacy as Assessed by 2-year PSA Progression-free Survival Rate [ Time Frame: 2 years ]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.
- Safety of the Multimodality Therapy as Assessed by Number of Participants With Neutropenia and Surgical or Radiation Toxicities [ 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.
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.
- 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.
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|