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

NCT02998242 | Completed DMC

• 1 other identifier: ARCAP
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

• biochemical disease free survival

  2 years

Study Arms (2)

RT alone

ACTIVE COMPARATOR

symptomatic bony metastatic site(s) receive SBRT less than 5 fractions

Radiation: SBRT to symptomatic bony metastatic bony site(s)

RT with apatinib

EXPERIMENTAL

selected dose administered PO during and after SBRT

Drug: Apatinib; Radiation: SBRT to symptomatic bony metastatic bony site(s)

Interventions

Apatinib DRUG

RT with apatinib

SBRT to symptomatic bony metastatic bony site(s) RADIATION

RT alone; RT with apatinib

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead
• Chang'An Hospital: collaborator
• Hainan Medical College: collaborator

MeSH Terms

Interventions

apatinib

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cancer Center

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 20, 2016
• Study Start: May 10, 2016
• Primary Completion: January 5, 2017
• Study Completion: December 10, 2017
• Last Updated: May 21, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share