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

Quality of Life Clinical Trial

— ARCAP  

Official title:

Apatinib in Combination With SBRT Treatment for Symptomatic Metastatic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02998242
• Other study ID #: ARCAP
• Status: Completed
• Phase: N/A
• Start date: May 10, 2016
• Est. completion date: December 10, 2017

Study information

• Verified date: May 2019
• Source: Sichuan Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 10, 2017
• Est. primary completion date: January 5, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Quality of Life

Intervention

Drug:
• Apatinib

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Sichuan Provincial People's Hospital	Chang'An Hospital, Hainan Medical College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biochemical disease free survival		2 years