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
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Condition or disease | Intervention/treatment | Phase |
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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 |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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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.
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Drug: Leuprolide Acetate
22.5mg by intramuscular (IM) injection every 3 months
Other Name: Lupron Deport Drug: Docetaxel 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 Drug: Bicalutamide bicalutamide (Casodex) 50mg by mouth daily
Other Name: Casodex Radiation: Radiation 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.

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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 PET scan)
Exclusion Criteria:
- Prior local non-surgical therapy to treat prostate cancer (e.g. radiation therapy, brachytherapy)
- Prior therapy to a metastatic site.
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Prior or ongoing systemic therapy for prostate cancer including, but not limited to:
- Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix)
- CYP-17 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.
- Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
- Abnormal bone marrow function [absolute neutrophil count (ANC)<1500/mm3, platelet count <100,000/mm3, hemoglobin <9 g/dL]
- Abnormal liver function (bilirubin >ULN; AST, ALT > 2.5 x upper limit of normal)
- Creatinine clearance of ≥ 30 mL/min. CrCl should be calculated suing the Cockcroft-Gault formula.
- Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within previous six months.
- Prior history of malignancy in the past 3 years with the exception of basal cell and squamous cell carcinoma of the skin. Other malignancies that are considered to have a low potential to progress may be enrolled at discretion of PI.

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 |
Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
ClinicalTrials.gov Identifier: | NCT03043807 |
Other Study ID Numbers: |
J16151 IRB00120414 ( Other Identifier: JHU IRB ) |
First Posted: | February 6, 2017 Key Record Dates |
Last Update Posted: | March 31, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
prostatectomy androgen deprivation chemotherapy radiation |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Docetaxel Leuprolide Abiraterone Acetate Bicalutamide Antineoplastic Agents Tubulin Modulators Antimitotic Agents |
Mitosis Modulators Molecular Mechanisms of Pharmacological Action Fertility Agents, Female Fertility Agents Reproductive Control Agents Physiological Effects of Drugs Antineoplastic Agents, Hormonal Steroid Synthesis Inhibitors Enzyme Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Cytochrome P-450 Enzyme Inhibitors Androgen Antagonists |