A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy

NCT ID: NCT03043807

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-22
• Study Completion Date: 2022-10-17

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Leuprolide Acetate

Intervention Type: DRUG

22.5mg by intramuscular (IM) injection every 3 months

Docetaxel

Intervention Type: DRUG

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.

Bicalutamide

Intervention Type: DRUG

bicalutamide (Casodex) 50mg by mouth daily

Radiation

Intervention Type: 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.

Abiraterone Acetate

Intervention Type: DRUG

Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.

Interventions

Leuprolide Acetate

22.5mg by intramuscular (IM) injection every 3 months

Intervention Type: 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.

Intervention Type: DRUG

Bicalutamide

bicalutamide (Casodex) 50mg by mouth daily

Intervention Type: DRUG

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.

Intervention Type: RADIATION

Abiraterone Acetate

Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.

Intervention Type: DRUG

Other Intervention Names

Lupron Deport; Texotere; Casodex; Zytiga

Eligibility Criteria

Inclusion Criteria

1. Willing and able to provide written informed consent.

2. Age ≥ 18 years

3. Eastern cooperative oncology group (ECOG) performance status ≤2

4. Documented histologically confirmed adenocarcinoma of the prostate

5. 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.

6. 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

1. Prior local non-surgical therapy to treat prostate cancer (e.g. radiation therapy, brachytherapy)

2. Prior therapy to a metastatic site.

3. Prior or ongoing systemic therapy for prostate cancer including, but not limited to:

1. Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix)

2. CYP-17 (cytochrome P450 17α-hydroxy/17,20-lyase) inhibitors (e.g. ketoconazole)

3. Antiandrogens (e.g. bicalutamide, nilutamide)

4. Second generation antiandrogens (e.g. enzalutamide, abiraterone)

5. Immunotherapy (e.g. sipuleucel-T, ipilimumab)

6. 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.

4. 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.

5. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.

6. Abnormal bone marrow function [absolute neutrophil count (ANC)<1500/mm3, platelet count <100,000/mm3, hemoglobin <9 g/dL]

7. Abnormal liver function (bilirubin >ULN ( upper limit of normal); AST (aspartate aminotransferase), ALT (alanine transaminase) > 2.5 x upper limit of normal)

8. Creatinine clearance of ≥ 30 mL/min. CrCl (Creatinine clearance) should be calculated suing the Cockcroft-Gault formula.

9. Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within previous six months.

10. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth Pienta, MD

Role: PRINCIPAL_INVESTIGATOR

SKCCC at Johns Hopkins University

Locations

Johns Hopkins Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00120414

Identifier Type: OTHER

Identifier Source: secondary_id

J16151

Identifier Type: -

Identifier Source: org_study_id