A Study of Definitive Therapy to Treat Prostate Cancer

NCT02716974 | Completed Phase 2 Results DMC

• 2 other identifiers: J1618IRB00070003
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

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 neoadjuvant androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen deprivation. Androgen blockade will be the same throughout the course of treatment.

Conditions

Prostate Cancer

Keywords

Lupron; Bicalutamide; Docetaxel

Outcome Measures

Primary Outcomes (1)

• Efficacy as Assessed by 2-year PSA Progression-free Survival Rate

  To evaluate efficacy of multimodality therapy in men, defined as the 2 year PSA progression-free (PSA\<0.2 ng/ml) survival among men who have non-castrate testosterone levels 2 years after enrollment. Number of participants (who have non-castrate testosterone levels 2 years after enrollment) with PSA progression-free survival.

  2 years

Secondary Outcomes (2)

• Safety of the Multimodality Therapy as Assessed by Number of Participants With Neutropenia and Surgical or Radiation Toxicities

  3 years

• Time to Prostate-specific Antigen Recurrence

  3 years

Study Arms (1)

chemohormonal and definitive therapy

EXPERIMENTAL

(1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of neoadjuvant androgen deprivation (Leuprolide Acetate) and up to 6 cycles of chemotherapy (Docetaxel), (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen deprivation. Androgen blockade (Bicalutamide) will be the same throughout the course of treatment.

Drug: Leuprolide Acetate; Drug: Bicalutamide; Drug: Docetaxel; Procedure: Prostatectomy; Radiation: Radiation

Interventions

Leuprolide Acetate DRUG

22.5mg by intramuscular (IM) injection every 3 months

Also known as: Lupron Deport

chemohormonal and definitive therapy

Bicalutamide DRUG

bicalutamide (Casodex) 50mg by mouth daily

Also known as: Casodex

chemohormonal and definitive therapy

Docetaxel DRUG

Docetaxel (taxotere) 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles.

Also known as: Texotere

chemohormonal and definitive therapy

Prostatectomy PROCEDURE

Removal of the entire prostate gland, plus some surrounding tissue.

Also known as: Radical prostatectomy

chemohormonal and definitive therapy

Radiation RADIATION

5 high dose radiation treatments to the metastatic (tumor has spread to other parts of the body) sites.

chemohormonal and definitive therapy

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 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 prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. Additionally, must be willing to be treated with a full year 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 scan)
• Able to swallow the study drugs whole as tablets

You may not qualify if:

• Prior local therapy to treat prostate cancer (e.g. radical prostatectomy, 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)
• Cytochrome (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 1 year 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 \>upper limit of normal; aspartate aminotransferase , alanine aminotransferase \> 2.5 x upper limit of normal)
• Creatinine clearance of ≥ 30 mL/min. 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 (3)

Sibley Memorial Hospital

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

Location

Johns Hopkins School of Medicine - Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21205, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Leuprolide; bicalutamide; Docetaxel; Prostatectomy; Radiation

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; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Physical Phenomena

Results Point of Contact

• Title: Kenneth Pienta
• Organization: Johns Hopkins University School of Medicine

kpienta1@jh.edu

410-502-3137

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: March 17, 2016
• First Posted: March 23, 2016
• Study Start: June 1, 2016
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: August 4, 2022
• Results First Posted: August 4, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)