A Phase II Study of Definitive Therapy for Newly Diagnosed Men With Oligometastatic Prostate Cancer After Prostatectomy
Overview
- Phase
- Phase 2
- Intervention
- Leuprolide Acetate
- Conditions
- Prostate Cancer
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- Efficacy as Assessed by 3-year Prostate-specific Antigen Progression-free Survival Rate
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Willing and able to provide written informed consent.
- •Age ≥ 18 years
- •Eastern cooperative oncology group (ECOG) performance status ≤2
- •Documented histologically confirmed adenocarcinoma of the prostate
- •Willing to undergo the following therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of neoadjuvant 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. Additionally, must be willing to be treated with a full two years of androgen deprivation.
- •Oligometastatic prostate cancer: Stage T1-4, N0-1 and/or M1a-b (up to 5 metastatic lesions- including bone lesions and non-regional lymph nodes seen on bone scan, contrast enhanced CT scan, or positron emission tomography PET scan)
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:
- •Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix)
- •CYP-17 (cytochrome P450 17α-hydroxy/17,20-lyase) inhibitors (e.g. ketoconazole)
- •Antiandrogens (e.g. bicalutamide, nilutamide)
- •Second generation antiandrogens (e.g. enzalutamide, abiraterone)
- •Immunotherapy (e.g. sipuleucel-T, ipilimumab)
- •Chemotherapy (e.g. docetaxel, cabazitaxel) \*Note: may be enrolled if hormone therapy was recently initiated (\<90 days duration)). In the event that hormone therapy was initiated prior to study enrollment, the clock for 2 years of androgen deprivation would begin at the time of therapy initiation, rather than at study enrollment.
- •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.
Arms & Interventions
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.
Intervention: Leuprolide Acetate
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.
Intervention: Docetaxel
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.
Intervention: Bicalutamide
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.
Intervention: Radiation
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.
Intervention: Abiraterone Acetate
Outcomes
Primary Outcomes
Efficacy as Assessed by 3-year Prostate-specific Antigen Progression-free Survival Rate
Time Frame: 3 years
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.
Secondary Outcomes
- Safety of the 3 Years Multimodality Therapy Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4 Criteria and the Clavien-Dindo Classification(3 years)
- Time to Prostate-specific Antigen Recurrence(3 years)