Neoadjuvant Pembrolizumab Plus Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03753243|
Recruitment Status : Recruiting
First Posted : November 26, 2018
Last Update Posted : September 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Pembrolizumab Drug: Enzalutamide||Phase 2|
The investigators propose to study the effects of pembrolizumab combined with intensive androgen receptor (AR) targeting prior to prostatectomy with extended pelvic lymph node dissection in subjects with high-risk localized prostate cancer (HRLPC).
Trial Design- single arm, single-stage, open label Phase II of neoadjuvant immune-hormonal therapy in high-risk localized prostate cancer.
Objectives To evaluate efficacy and safety of pembrolizumab combined with intensive AR targeting prior to prostatectomy in subjects with high-risk localized prostate cancer (HRLPC).
Primary Endpoint Pathologic complete response (pCR) defined as absence of detectable malignant cells in the prostatectomy specimen evaluated by standard histologic techniques.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||single arm, single-stage open label Phase II of neoadjuvant immune-hormonal therapy in high-risk Localized prostate cancer.|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Neoadjuvant Pembrolizumab Plus Intensive Androgen Axis Blockade Prior to Prostatectomy for High Risk Localized Prostate Cancer|
|Actual Study Start Date :||December 3, 2018|
|Estimated Primary Completion Date :||April 3, 2021|
|Estimated Study Completion Date :||April 30, 2023|
Treatment will be planned for a total of 14 to 16 weeks. Pembrolizumab will be administered every 3 weeks via IV infusion with a dose of 200 mg per infusion. Enzalutamide will be given orally and dispensed to the patient on the date of their first infusion. The dosage of Enzalutamide will be 160 mg, administered once daily for approx. 16 weeks. GNRH agonist therapy will be administered as a standard of care therapy and will follow a standard dosage to maintain castrate levels.
Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
Other Name: Keytruda
Patients will receive daily oral doses of study drug (enzalutamide 160 mg/day), which will be administered as four capsules/day to be taken at or near the same time each day.
Other Name: Xtandi
- Pathologic Complete Response [ Time Frame: 4 months ]No cancer detected on pathology examination of prostatectomy specimen
- Treatment Related Adverse Events [ Time Frame: 4 months + 30 days ]Grade 3 or higher adverse event (AE) possibly related or related to any of three treatment drugs (pembrolizumab, enzalutamide, Gonadotropin-releasing hormone (GNRH) agonist) per CTCAE v4.03, evaluated up until 30 days after prostatectomy
- Immune -related Adverse Events [ Time Frame: 4 months + 30 days ]Grade 2 or higher immune related AE possibly related or related to any of three treatment drugs (pembrolizumab, enzalutamide, GNRH agonist) per CTCAE v4.03, evaluated up until 30 days after prostatectomy
- Biochemical Complete Response [ Time Frame: 4 months ]Prostate-Specific Antigen (PSA) < 0.1 ng/mL prior to prostatectomy
- Incidence of Surgical Complications [ Time Frame: 4 months ]Clavien-Dindo Classification of Surgical Complications compared to historical department incidence rates.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753243
|Contact: Wesley Stoller, MA||5032208262 ext firstname.lastname@example.org|
|Contact: Mark Garzotto, MD||5032208262 ext email@example.com|
|United States, Oregon|
|VA Portland Healthcare System||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Wesley Stoller, MA 503-220-8262 ext 54931 firstname.lastname@example.org|
|Principal Investigator: Mark Garzotto, MD|
|Principal Investigator:||Mark Garzotto, MD||Portland VA Medical Center|