A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy

NCT03043807 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: J16151IRB00120414
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

prostatectomy; androgen deprivation; chemotherapy; radiation

Outcome Measures

Primary Outcomes (1)

• Efficacy as Assessed by 3-year Prostate-specific Antigen Progression-free Survival Rate

  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.

  3 years

Secondary Outcomes (2)

• 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

Study Arms (1)

chemohormonal and definitive therapy after prostatectomy

EXPERIMENTAL

(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; Drug: Docetaxel; Drug: Bicalutamide; Radiation: Radiation; Drug: Abiraterone Acetate

Interventions

Leuprolide Acetate DRUG

22.5mg by intramuscular (IM) injection every 3 months

Also known as: Lupron Deport

chemohormonal and definitive therapy after prostatectomy

Docetaxel 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.

Also known as: Texotere

chemohormonal and definitive therapy after prostatectomy

Bicalutamide DRUG

bicalutamide (Casodex) 50mg by mouth daily

Also known as: Casodex

chemohormonal and definitive therapy after prostatectomy

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.

chemohormonal and definitive therapy after prostatectomy

Abiraterone Acetate DRUG

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

Also known as: Zytiga

chemohormonal and definitive therapy after prostatectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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 ( upper limit of normal); AST (aspartate aminotransferase), ALT (alanine transaminase) \> 2.5 x upper limit of normal)
• Creatinine clearance of ≥ 30 mL/min. CrCl (Creatinine clearance) 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (2)

Johns Hopkins Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Leuprolide; Docetaxel; bicalutamide; Radiation; Abiraterone Acetate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Physical Phenomena; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Kenneth Pienta
• Organization: Johns Hopkins University

kpienta1@jh.edu

4105023137

Study Officials

• Kenneth Pienta, MD

  SKCCC at Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 6, 2017
• Study Start: February 22, 2017
• Primary Completion: October 17, 2022
• Study Completion: October 17, 2022
• Last Updated: February 16, 2023
• Results First Posted: February 16, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)