Prostate CancerPhase 2TALONNCT04569461
Trimodality Approach of Low Dose iOnizing Radiation With or Without Neoadjuvant Pembrolizumab and Prostatectomy for Men With Intermediate/High Risk Prostate Cancer (TALON)
A Phase 2 study testing pembrolizumab, Low dose prostate radiation and Radical Prostatectomy in people with Prostate Cancer, run by Duke University at 1 site in United States.
Trial summary
This study will enroll prostate cancer patients with an unfavorable intermediate- or high-risk diagnosis. The purpose of this study is to determine whether a regimen of pembrolizumab and low dose prostate radiation or low dose prostate radiation alone prior to a prostatectomy affects cells of the immune system and if… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- pembrolizumab, Low dose prostate radiation and Radical Prostatectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2025to 1 Dec 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and the willingness to sign a written informed consent document.
- Age ≥ 18 years
- Histologic evidence of adenocarcinoma of the prostate who are deemed candidates for radical prostatectomy. Variants such as neuroendocrine components or ductal carcinoma are allowed. Pure small cell carcinoma is not allowed.
- At least one unfavorable intermediate or high risk factors or classified as high risk clinically localized disease as defined by NCCN guidelines:
- High risk: At least one of the following: i. cT3a disease ii. Gleason sum of 8, 9 or 10 iii. PSA ≥ 20 ng/ml
- At least one of the following unfavorable intermediate risk factors:: i. cT2b or cT2c disease ii. Grade group 3 iii. PSA 10-20 ng/ml iv. Grade group 2 and 50% or greater prostate biopsies positive for cancer
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (See Appendix A)
- Adequate normal organ and marrow function as defined below by the following criteria within 10 days prior to first dose of study treatment.:
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count (ANC ≥1.5 x 10^9/L)
- Platelet count ≥100 x 10^9/L
- Serum bilirubin ≤ 1.5 x Institutional Upper Limit of Normal (ULN)
- AST/SGOT and ALT/SGPT ≤ 2.5 x ULN
- Measured creatinine clearance (CL) >50 mL/min
- 8. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Who cannot join
- History of or known bone, brain, visceral, or soft tissue metastasis, including lymph nodes based on standard of care imaging with CT or pelvic MRI showing no LNs greater than 1.5cm and bone scan showing no evidence of bone metastasis.
- Prior pelvic radiation or prostate cryotherapy or high-intensity focused ultrasound (HIFU)
- Any prior treatment with PD-1 or PD-L1 checkpoint inhibitors or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137, PD-L2).
- Has received an investigational agent (or used an investigational device) within 4 weeks prior to study intervention administration.
- Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Prior therapy for prostate cancer
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- Exceptions: Previous alpha-reductase inhibitor use allowed IF patient has not been taking for at least 30 days prior to study treatment initiation, OR if alpha reductase inhibitor was not used as a primary treatment of prostate cancer and the PSA on alpha-reductase inhibitor remains within eligibility when doubled.
- Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid).
- Presence of a condition requiring chronic steroid use (equivalent to >10 mg of prednisone daily) or other immunosuppressive drugs (i.e., for organ transplant). The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
- History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of investigational product (IP) and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease
- History of allogenic stem cell transplant
- History of active primary immunodeficiency
- Known history of human immunodeficiency virus
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
- Has not adequately recovered from major surgery or has ongoing surgical complications.
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Any condition which, in the opinion of the investigator, would preclude participation in this trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
This study will enroll prostate cancer patients with an unfavorable intermediate- or high-risk diagnosis. The purpose of this study is to determine whether a regimen of pembrolizumab and low dose prostate radiation or low dose prostate radiation alone prior to a prostatectomy affects cells of the immune system and if it is a safe option for this stage of prostate cancer. Participants will be randomized 1:1 (like flipping a coin) to receive pembrolizumab, low dose prostate radiation and a prostatectomy or low dose prostate radiation and a prostatectomy. Pembrolizumab is an investigational drug that increases the ability of the immune system to kill tumor cells. Low dose radiation can alter the way tumor cells look to the immune cells. For example, the immune cells may express different proteins that make them more susceptible to immune cell killing or the structure of the tumor may be altered to allow the immune cells to infiltrate the tumor more thoroughly. The prostate tissue collected from the prostatectomy will be analyzed for differences in pathology and local immune cell infiltration, and participants will be followed for 2 years to watch for prostate specific antigen (PSA) recurrence and prostate cancer recurrence.
- Conditions
- Prostate Cancer
- Being tested
- pembrolizumab, Low dose prostate radiation, Radical Prostatectomy
- Keywords
- prostate cancer, KEYTRUDA, pembrolizumab, prostatectomy, localized prostate cancer, prostate radiation, low dose prostate radiation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pembrolizumabDrug
Also called KEYTRUDA
400 mg of pembrolizumab (KEYTRUDA) will be given by IV every 6 weeks for 9 cycles, for approximately one year of study drug administration.
Low dose prostate radiationRadiation
A single dose of 2 Gy of radiation will be given to the prostate and seminal vesicles on approximately Week 7 for Arm A and approximately 2 weeks prior to the prostatectomy for Arm B.
Radical ProstatectomyProcedure or surgery
Also called Robotic assisted laparoscopic prostatectomy (RALP)
Robotic assisted laparoscopic prostatectomy (RALP) surgery will be performed at approximately Week 9 for Arm A and approximately 2 weeks after the low dose prostate radiation for Arm B. This surgery is part of the participants routine medical care.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: pembrolizumab, low dose prostate radiation and prostatectomy | Experimental | Participants in Arm A will receive:
* Pembrolizumab 400 mg intravenously every 6 weeks for 9 cycles.
* Low dose prostate radiation of one dose of 2 Gy to the prostate and seminal vesicles
* Prostatectomy as part of the routine care for their cancer Receives: Drug: pembrolizumab; Radiation: Low dose prostate radiation; Procedure: Radical Prostatectomy |
| Arm B: Low dose prostate radiation and prostatectomy | Experimental | Participants in Arm B will receive:
* Low dose prostate radiation of one dose of 2 Gy to the prostate and seminal vesicles
* Prostatectomy as part of the routine care for their cancer Receives: Radiation: Low dose prostate radiation; Procedure: Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of CD8+ T-cells in prostatectomy samples
Total number of CD8+ T-cell profiles in prostate tumor samples removed by RALP in men treated with preoperative low dose prostate radiation (LDPR) alone or with preoperative pembrolizumab.
Measured: Prostatectomy (Week 7 for Arm A, Week 3 for Arm B)
Location of CD8+ T-cells in prostatectomy samples
Description of location of CD8+ T-cell profiles of prostate tumor samples removed by RALP in men treated with preoperative low dose prostate radiation (LDPR) alone or with preoperative pembrolizumab.
Measured: Prostatectomy (Week 7 for Arm A, Week 3 for Arm B)
Characteristics of CD8+ T-cells in prostatectomy samples
Description of Characteristics of CD8+ T-cell profiles of prostate tumor samples removed by RALP in men treated with preoperative low dose prostate radiation (LDPR) alone or with preoperative pembrolizumab.
Measured: Prostatectomy (Week 7 for Arm A, Week 3 for Arm B)
Secondary outcomes (2)
Acute safety profile
Description of the acute (30 day) safety profile of participants receiving low dose prostate radiation pre-operatively with or without pembrolizumab
Measured: 30 days after prostatectomy
Long term safety profile
Description of the long term (2 year) safety profile of participants receiving low dose prostate radiation pre-operatively with or without pembrolizumab
Measured: 2 years after prostatectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study startJun 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Why it stopped: Discontinuation of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Daniel George, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569461
- Sponsor's protocol ID
- Pro00103396
- Acronym
- TALON
- Status last verified
- Jul 2025
- First submitted
- 23 Sep 2020
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trimodality Approach of Low Dose iOnizing Radiation With or Without Neoadjuvant Pembrolizumab and Prostatectomy for Men With Intermediate/High Risk Prostate Cancer (TALON)
- ClinicalTrials.gov ID
- NCT04569461
- Acronym / sponsor ID
- TALON / Pro00103396
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, KEYTRUDA, pembrolizumab, prostatectomy, localized prostate cancer, prostate radiation, low dose prostate radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Discontinuation of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jun 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will enroll prostate cancer patients with an unfavorable intermediate- or high-risk diagnosis. The purpose of this study is to determine whether a regimen of pembrolizumab and low dose prostate radiation or low dose prostate radiation alone prior to a prostatectomy affects cells of the immune system and if it is a safe option for this stage of prostate cancer. Participants will be randomized 1:1 (like flipping a coin) to receive pembrolizumab, low dose prostate radiation and a prostatectomy or low dose prostate radiation and a prostatectomy. Pembrolizumab is an investigational drug that increases the ability of the immune system to kill tumor cells. Low dose radiation can alter the way tumor cells look to the immune cells. For example, the immune cells may express different proteins that make them more susceptible to immune cell killing or the structure of the tumor may be altered to allow the immune cells to infiltrate the tumor more thoroughly. The prostate tissue collected from the prostatectomy will be analyzed for differences in pathology and local immune cell infiltration, and participants will be followed for 2 years to watch for prostate specific antigen (PSA) recurrence and prostate cancer recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: pembrolizumab, low dose prostate radiation and prostatectomy | Experimental | Drug: pembrolizumab, Radiation: Low dose prostate radiation, Procedure: Radical ProstatectomyParticipants in Arm A will receive: * Pembrolizumab 400 mg intravenously every 6 weeks for 9 cycles. * Low dose prostate radiation of one dose of 2 Gy to the prostate and seminal vesicles * Prostatectomy as part of the routine care for their cancer |
| Arm B: Low dose prostate radiation and prostatectomy | Experimental | Radiation: Low dose prostate radiation, Procedure: Radical ProstatectomyParticipants in Arm B will receive: * Low dose prostate radiation of one dose of 2 Gy to the prostate and seminal vesicles * Prostatectomy as part of the routine care for their cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Ability to understand and the willingness to sign a written informed consent document.
- Age ≥ 18 years
- Histologic evidence of adenocarcinoma of the prostate who are deemed candidates for radical prostatectomy. Variants such as neuroendocrine components or ductal carcinoma are allowed. Pure small cell carcinoma is not allowed.
- At least one unfavorable intermediate or high risk factors or classified as high risk clinically localized disease as defined by NCCN guidelines:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (See Appendix A)
Key exclusion criteria (26 listed)
- History of or known bone, brain, visceral, or soft tissue metastasis, including lymph nodes based on standard of care imaging with CT or pelvic MRI showing no LNs greater than 1.5cm and bone scan showing no evidence of bone metastasis.
- Prior pelvic radiation or prostate cryotherapy or high-intensity focused ultrasound (HIFU)
- Any prior treatment with PD-1 or PD-L1 checkpoint inhibitors or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137, PD-L2).
- Has received an investigational agent (or used an investigational device) within 4 weeks prior to study intervention administration.
- Prior therapy for prostate cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pembrolizumabAlso: KEYTRUDA400 mg of pembrolizumab (KEYTRUDA) will be given by IV every 6 weeks for 9 cycles, for approximately one year of study drug administration. | Drug | Arm A: pembrolizumab, low dose prostate radiation and prostatectomy |
| Low dose prostate radiationA single dose of 2 Gy of radiation will be given to the prostate and seminal vesicles on approximately Week 7 for Arm A and approximately 2 weeks prior to the prostatectomy for Arm B. | Radiation | Arm A: pembrolizumab, low dose prostate radiation and prostatectomy, Arm B: Low dose prostate radiation and prostatectomy |
| Radical ProstatectomyAlso: Robotic assisted laparoscopic prostatectomy (RALP)Robotic assisted laparoscopic prostatectomy (RALP) surgery will be performed at approximately Week 9 for Arm A and approximately 2 weeks after the low dose prostate radiation for Arm B. This surgery is part of the participants routine medical care. | Procedure or surgery | Arm A: pembrolizumab, low dose prostate radiation and prostatectomy, Arm B: Low dose prostate radiation and prostatectomy |
Primary outcome
Total number of CD8+ T-cells in prostatectomy samples
Time frame: Prostatectomy (Week 7 for Arm A, Week 3 for Arm B)
Total number of CD8+ T-cell profiles in prostate tumor samples removed by RALP in men treated with preoperative low dose prostate radiation (LDPR) alone or with preoperative pembrolizumab.
Location of CD8+ T-cells in prostatectomy samples
Time frame: Prostatectomy (Week 7 for Arm A, Week 3 for Arm B)
Description of location of CD8+ T-cell profiles of prostate tumor samples removed by RALP in men treated with preoperative low dose prostate radiation (LDPR) alone or with preoperative pembrolizumab.
Characteristics of CD8+ T-cells in prostatectomy samples
Time frame: Prostatectomy (Week 7 for Arm A, Week 3 for Arm B)
Description of Characteristics of CD8+ T-cell profiles of prostate tumor samples removed by RALP in men treated with preoperative low dose prostate radiation (LDPR) alone or with preoperative pembrolizumab.
2 secondary outcomes
Acute safety profile
Time frame: 30 days after prostatectomy
Long term safety profile
Time frame: 2 years after prostatectomy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel George, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pembrolizumab, Low dose prostate radiation and Radical Prostatectomy in people with Prostate Cancer, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of CD8+ T-cells in prostatectomy samples (time frame: Prostatectomy (Week 7 for Arm A, Week 3 for Arm B)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.