A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy
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|ClinicalTrials.gov Identifier: NCT03043807|
Recruitment Status : Active, not recruiting
First Posted : February 6, 2017
Last Update Posted : December 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Leuprolide Acetate Drug: Docetaxel Drug: Bicalutamide Radiation: Radiation Drug: Abiraterone Acetate||Phase 2|
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 PSA response of at least a 50% decrease from baseline, will proceed to maximum consolidative therapy.
Local consolidation (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).
Systemic consolidation: Patients will continue on androgen deprivation for a total of 2 years. They will be followed clinically and monitored with serum testosterone and PSA 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 After Prostatectomy|
|Actual Study Start Date :||February 22, 2017|
|Estimated Primary Completion Date :||February 2022|
|Estimated Study Completion Date :||February 2022|
Experimental: 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.
Drug: Leuprolide Acetate
22.5mg by intramuscular (IM) injection every 3 months
Other Name: Lupron Deport
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.
Other Name: Texotere
bicalutamide (Casodex) 50mg by mouth daily
Other Name: Casodex
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.
Drug: Abiraterone Acetate
Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.
Other Name: Zytiga
- Safety of the multimodality therapy assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4 criteria and the Clavien-Dindo Classification [ Time Frame: 3 years ]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
- Two-year Undetectable PSA [ Time Frame: 2 years ]To investigate the total number and the percentage of men with an undetectable PSA at 2 years after study enrollment.
- Time to PSA recurrence [ Time Frame: 3 years ]To investigate the time from an undetectable PSA (≤0.2 ng/mL) until the PSA 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
- 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 PET 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 PET scan).
- Overall survival [ Time Frame: 5 years ]To measure the period from study enrollment until death from any cause.
- Quality of life [ Time Frame: 3 years ]To measure quality of life through the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire, supplemented with the FACT-Taxane questionnaire
- 5 years overall survival [ Time Frame: 5 years ]Improved 5-yr overall survival (OS) as compared to 5-yr OS in men with metastatic prostate cancer included in the Surveillance, Epidemiology, and End Results (SEER) 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): NCT03043807
|United States, District of Columbia|
|Johns Hopkins Sibley Memorial Hospital|
|Washington, District of Columbia, United States, 20016|
|United States, Maryland|
|The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||Kenneth Pienta, MD||SKCCC at Johns Hopkins University|