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 : March 31, 2022
|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.
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 PSA 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 After Prostatectomy|
|Actual Study Start Date :||February 22, 2017|
|Estimated Primary Completion Date :||February 2023|
|Estimated Study Completion Date :||February 2024|
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
- Efficacy as assessed by 3-year PSA progression-free survival rate [ Time Frame: 3 years ]To evaluate efficacy of multimodality therapy in men, defined as the 3 year PSA progression-free (PSA<0.2 ng/ml) survival rate among men who have non-castrate testosterone levels 2 years after enrollment.
- Safety of the 3 years multimodality therapy assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4 criteria and the Clavien-Dindo Classification [ Time Frame: 2 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
- 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.
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|