Apatinib in Combination With Stereotactic Body Radiation Therapy (SBRT) Treatment for Symptomatic Metastatic Prostate Cancer (ARCAP)

May 20, 2019 updated by: ming zeng, MD, Sichuan Provincial People's Hospital

Apatinib in Combination With SBRT Treatment for Symptomatic Metastatic

To study safety and efficacy of apatinib in combination of radiotherapy in patients with symptomatic bony disease prostate cancer (SBPC), based on the potential synergistic antitumor activity between Apatinib and Stereotactic Body Radiation Therapy (SBRT).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Histologic diagnosis of adenocarcinoma of the prostate
  • Metastatic and symptomatic prostate cancer (positive bone scan or measurable disease)
  • Patients must stop using any herbal product known to decrease PSA levels (eg., saw palmetto and PC-SPES) or any systemic or topical corticosteroid at least 4 weeks prior to screening. Progressive disease must be documented after discontinuation of these products.
  • Progressive disease after androgen deprivation (or hormone therapy). For patients with measurable disease, progression will be defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. For patients with progression in, or without any measurable disease, a positive bone scan and elevated PSA will be required.
  • Patients receiving bisphosphate therapy must have been on stable doses for at least 4 weeks with stable symptoms prior to enrollment.
  • No prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control prostate cancer).
  • Prior radiation therapy completed at least 4 weeks prior to enrollment. No prior radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.

Exclusion Criteria:

  • History of severe hypersensitivity reactions to drugs formulated with polysorbate 80.
  • Patients with active autoimmune disease or a history of autoimmune disease that required systemic steroids or immunosuppressive medications, except for patients with vitiligo.
  • Prior therapy with any anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) antibody.
  • Active infection requiring therapy.
  • Concurrent medical condition requiring the use of systemic or topical corticosteroids; systemic or topical corticosteroids must be discontinued at least 4 weeks prior to enrollment. The use of inhaled corticosteroids is acceptable.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: RT alone
symptomatic bony metastatic site(s) receive SBRT less than 5 fractions
Radiation: SBRT to symptomatic bony metastatic bony site(s)
EXPERIMENTAL: RT with apatinib
selected dose administered PO during and after SBRT
Drug: Apatinib
Radiation: SBRT to symptomatic bony metastatic bony site(s)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
biochemical disease free survival
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan Provincial People's Hospital

Collaborators

Hainan Medical College
Chang'An Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 10, 2016

Primary Completion (ACTUAL)

January 5, 2017

Study Completion (ACTUAL)

December 10, 2017

Study Registration Dates

First Submitted

December 12, 2016

First Submitted That Met QC Criteria

December 15, 2016

First Posted (ESTIMATE)

December 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 21, 2019

Last Update Submitted That Met QC Criteria

May 20, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARCAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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