Trimodality Approach to Localized Prostate Cancer: Pembrolizumab, ADT, and SBRT Followed by Prostatectomy (TALON)
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|ClinicalTrials.gov Identifier: NCT04569461|
Recruitment Status : Not yet recruiting
First Posted : September 29, 2020
Last Update Posted : September 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: pembrolizumab Radiation: Stereotactic body radiation therapy Drug: Short-term androgen deprivation therapy Procedure: Radical Prostatectomy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Trimodality Approach to Unfavorable Localized Prostate Cancer: a Prospective Trial of Neoadjuvant Pembrolizumab, ADT, and Prostate SBRT Followed by Radical Prostatectomy|
|Estimated Study Start Date :||November 1, 2020|
|Estimated Primary Completion Date :||January 1, 2025|
|Estimated Study Completion Date :||January 1, 2025|
Experimental: Single Arm
Subjects with unfavorable localized prostate cancer will be enrolled.This is a single arm, phase II study of pembrolizumab (Keytruda), SBRT, and Short-term Androgen Deprivation Therapy (STADT), known together as trimodality therapy, followed by radical prostatectomy 8 weeks after SBRT.
200 mg of Pembrolizumab (KEYTRUDA) will be given by IV every 3 weeks for 5 cycles, a total of 15 weeks of treatment.
Other Name: KEYTRUDA
Radiation: Stereotactic body radiation therapy
SBRT will begin on week 7 of the study. The radiation will be given every other day in 5 fractions of 6 Gy for a total of 30 Gy of radiation exposure.
Other Name: SBRT
Drug: Short-term androgen deprivation therapy
Short-term ADT will last for five months. It will consist of treatment with a 1 month dose beginning on Day 0 of the study. Then it will continue with either a single 4 month dose on week 5, or 4 additional 1 month doses, depending on patient and physician preference.
Procedure: Radical Prostatectomy
Radical prostatectomy surgery will be performed between week 17 and week 20 of the study, as scheduling permits.
Other Name: RP
- Percentage of subjects who achieve biochemical progression-free survival (BPFS) at 24 months (2 years) [ Time Frame: 24 months ]BPFS will be defined as at least two PSAs 6+ weeks apart with first PSA > 0.2 ng/ml and second PSA >0.2 ng/ml occurring at least 3 months after surgery
- Pathologic response in prostatectomy tissue [ Time Frame: Through study completion, up to 1 year after last prostatectomy ]Pathologic response will be graded using a published 3-point scale.
- 12 week post-operative PSA [ Time Frame: 12 weeks after prostatectomy ]12 week post-operative PSA after pembrolizumab/SBRT/STADT/ RP,
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): NCT04569461
|Contact: Julia Hurrelbrink, RN, BSNfirstname.lastname@example.org|
|Contact: Bridget Koontz, MD|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Contact: Julia Hurrelbrink, RN, BSN 919-681-1030 email@example.com|
|Principal Investigator: Bridget Koontz, MD|
|Principal Investigator:||Bridget Koontz, MD||Duke University|