Intermediate Risk Prostate CancerPhase 2ARPEGGIONCT07393867
Androgen-responsive POSLUMA-guided Intra-prostatic Boost
A Phase 2 study testing PSMA PET/CT, Androgen Deprivation Therapy (ADT) +/- bicalutamide and Stereotactic Body Radiation Therapy (SBRT) +/- focal microboost in people with Intermediate Risk Prostate Cancer and High Risk Prostate Cancer, run by Martin T. King, MD, PhD at 4 sites in United States.
Trial summary
This research study is for men with intermediate- or high-risk prostate cancer who are planning to receive hormone therapy and radiation treatment. The purpose of the study is to see whether a special type of diagnostic imaging done during hormone therapy can help doctors more accurately target remaining cancer with… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Intermediate Risk Prostate Cancer, High Risk Prostate Cancer, Prostate Cancer
- What is being tested?
- PSMA PET/CT, Androgen Deprivation Therapy (ADT) +/- bicalutamide and Stereotactic Body Radiation Therapy (SBRT) +/- focal microboost
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Apr 2026to 15 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- 18 years of age and older.
- Eastern Oncology Group Status 0 to 1.
- Histologic diagnosis of prostate cancer.
- Prior screening MRI with at least one PI-RADS4 or PI-RADS 5 lesion, obtained within 180 days of screening.
- NCCN intermediate-risk or high-risk prostate cancer (Appendix B). All patients will be staged by MRI.
- Prior PSMA PET scan with at least one focal avid lesion greater than background prostate that is concordant with a lesion on MRI, obtained within 180 days of screening.
- Intention for SBRT (36.25 Gy/5 fraction) with focal boost (up to 50 Gy) to one MRI/PET-concordant lesion34.
Who cannot join
- Prior imaging (CT, bone scan, MRI, PSMA-PET/CT) showing nodal or distant disease.
- Intention to receive treatment intensification with secondary androgen receptor signaling inhibitors or chemotherapy.
- Clinical T4 disease.
- Prior ADT.
- Prior pelvic RT.
- Prior prostate surgery, including TURP.
Show all 12Show fewer
- International prostate symptom score > 20.
- Prior urethral stricture.
- Prostate volume > 80 cc on MRI.
- Hip implants that cause artifacts over the prostate gland.
- Inability to discontinue anti-coagulation for fiducial marker placement.
- Active Crohn's disease or scleroderma.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Not yet recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
- Not yet recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
- Recruiting
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
Milford, Massachusetts, 01757
Luke Peng, MD, 508-488-3800, lcpeng@bwh.harvard.edu
- Recruiting
Dana-Farber/Brigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital
Weymouth, Massachusetts, 02190
Luke Peng, 508-488-3800, lcpeng@bwh.harvard.edu
About this study
Official title: Androgen-responsive POSLUMA-guided Intra-prostatic Boost (ARPEGGIO)
This research study is for men with intermediate- or high-risk prostate cancer who are planning to receive hormone therapy and radiation treatment. The purpose of the study is to see whether a special type of diagnostic imaging done during hormone therapy can help doctors more accurately target remaining cancer with radiation, while avoiding areas that may no longer need extra treatment. All participants will receive standard hormone therapy and radiation therapy, along with three imaging scans, over a six-month period. The information gained from this study may help make prostate cancer radiation treatment more precise and reduce side effects for future patients.
Read the detailed description
Prostate cancer is commonly treated with a combination of hormone therapy and radiation therapy. Hormone therapy, or androgen deprivation therapy (ADT), lowers testosterone levels and often shrinks or weakens prostate cancer before radiation begins. However, after hormone therapy starts, it can become harder for doctors to tell exactly where active cancer remains inside the prostate using standard imaging (typically an MRI). This study is being conducted to determine whether a newer imaging test can better identify which parts of the cancer are still active and may benefit from more focused radiation treatment.
All participants in this study will receive six months of ADT, which is part of standard care for intermediate- and high-risk prostate cancer. In addition, participants will undergo PSMA PET/CT scans, a type of imaging that highlights prostate cancer cells, as well as MRI scans. These scans will be performed at three time-points: before hormone therapy begins, approximately eight weeks after starting hormone therapy (before radiation planning), and again at 24 weeks (at the end of all treatment) to see how the cancer has responded to treatment.
Radiation therapy will begin shortly after the eight-week imaging scan. Participants will receive high-precision radiation (stereotactic body radiation therapy/SBRT) to the prostate over about two weeks. Based on the imaging results, doctors may give an extra "boost" of radiation to small areas that still show signs of active cancer. If the scans show that the cancer has responded well to hormone therapy, some patients may not need this extra boost. This approach is designed to deliver the strongest treatment where it is needed while limiting radiation to healthy tissue in order to minimize side effects.
The main goal of the study is to understand whether doctors can confidently use the mid-treatment PSMA PET/CT scan to guide radiation planning. Researchers will also monitor changes in PSA blood levels, imaging findings, treatment side effects, and patient-reported quality of life, including urinary, bowel, and sexual symptoms. Additionally, doctors participating in the study will provide feedback on how easy or difficult it is to define radiation target areas using the different scans.
Participation in this study lasts about 6 months, and all treatments provided are commonly used in prostate cancer care, with the incorporation of PSMA PET scans being the experimental component. While participants may or may not directly benefit, the results obtained from this study may help improve how radiation therapy is planned and delivered for future patients with prostate cancer, with the goal of maintaining treatment effectiveness while reducing side effects.
- Being tested
- PSMA PET/CT, Androgen Deprivation Therapy (ADT) +/- bicalutamide, Stereotactic Body Radiation Therapy (SBRT) +/- focal microboost
- Keywords
- POSLUMA, prostate-specific membrane antigen positron-emission tomography, PSMA-PET/CT, 18F-flotufolastat-PSMA-PET/CT scan, ADT and 18F-flotufolastat-guided focal SBRT microboost, androgen deprivation therapy and 18F-flotufolastat-guided focal SBRT microboost, neoadjuvant ADT, neoadjuvant androgen deprivation therapy, neoadjuvant ADT prior to SBRT, 18F-flotufolastat-PET/CT scans for intermediate and high risk prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA PET/CTDiagnostic test
PSMA PET/CT is an imaging test that uses a radioactive tracer to highlight prostate cancer cells. Imaging will be performed at baseline, approximately eight weeks after starting ADT, and approximately 24 weeks after starting ADT (end of treatment). These scans are used to guide radiation treatment planning and assess treatment response.
Androgen Deprivation Therapy (ADT) +/- bicalutamideDrug
ADT is used to lower testosterone levels, which can slow or shrink prostate tumors. All participants will receive approximately six months of ADT starting before radiation therapy, using injectable or oral medications. Depending on the type of ADT, participants may also receive daily bicalutamide. Bicalutamide is categorized as an antiandrogen, which means it will block the effects of testosterone and work together with ADT to slow down or shrink prostate cancer.
Stereotactic Body Radiation Therapy (SBRT) +/- focal microboostRadiation
SBRT is a form of radiation therapy that delivers precise, high-dose radiation to the prostate over a short period of time. SBRT will be initiated 10 weeks after initiation of ADT and will be delivered in five sessions over two weeks. Based on PSMA PET/CT and MRI findings after initiation of ADT, some participants may receive an optional focal radiation microboost to areas of residual cancer. The microboost, if delivered, will be given during the same SBRT treatment sessions and will be limited by standard safety constraints.
| Study group | Role | What they receive |
|---|---|---|
| ADT + SBRT + PSMA PET/CT Imaging | Experimental | * ADT as prescribed
* PSMA PET/CT imaging will be completed at baseline, 8 weeks after ADT start, and at end of treatment
* SBRT is administered starting 10 weeks after ADT start Receives: Diagnostic Test: PSMA PET/CT; Drug: Androgen Deprivation Therapy (ADT) +/- bicalutamide; Radiation: Stereotactic Body Radiation Therapy (SBRT) +/- focal microboost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with GTV treatment contours that are highly concordant with GTV-combined interim.
To evaluate whether >50% of patients will be treated utilizing GTV contours that are highly concordant with those from interim PET/MR scans (GTV-combined-interim) based on the dice coefficient
Measured: 8 weeks from initiation of hormone therapy/before start of radiation therapy
Secondary outcomes (4)
Geometric accuracies of GTV-Combined-Baseline and GTV-combined-interim contours
The Dice coefficient of GTV-Combined-Baseline contours by the treating physician versus those independently drawn by the principal investigator will be calculated. The Dice coefficient of GTV-Combined-Interim contours by the treating physician versus those independently drawn by the principal investigator will also be calculated.
Measured: 8 weeks from initiation of hormone therapy/before start of radiation therapy
PSA response
The median PSA values at 8-weeks and 24-weeks will be evaluated. The percentage of patients with a PSA≥0.1 ng/mL will be calculated.
Measured: 8 weeks from initiation of hormone therapy and 24 weeks from initiation of hormone therapy (end of treatment)
PSMA PET response
PSMA-PET/CT response at 8-weeks and 24-weeks will be characterized utilizing PSMA PET RECIP 1.0 criteria.
- Complete response: Absence of any PSMA uptake at interim PET.
- Partial: 30% or greater decrease in PSMA-avid total tumor volume.
- Progression: 20% or greater increase in total tumor volume. New PSMA-avid lesions will also count as progression.
- Stable disease: Less than 30% decrease or less than 20% increase in total tumor volume.
Measured: 8 weeks from initiation of hormone therapy and 24 weeks from initiation of hormone therapy (end of treatment)
MRI ADC contrast ratio
The ADC contrast ratio at baseline and 8-weeks will be calculated by evaluating the ratio of the mean ADC contrast within GTV-MRI against ADC contrast within a surrounding 2 mm ring.
Measured: 8 weeks from initiation of hormone therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start29 Apr 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermediate Risk Prostate CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martin T. King, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Diagnostics, Dana-Farber/Brigham and Women's Cancer Center
- Responsible party
- Sponsor-investigator, Martin T. King, MD, PhD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393867
- Sponsor's protocol ID
- 25-708
- Acronym
- ARPEGGIO
- Status last verified
- May 2026
- First submitted
- 27 Jan 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Androgen-responsive POSLUMA-guided Intra-prostatic Boost (ARPEGGIO)
- ClinicalTrials.gov ID
- NCT07393867
- Acronym / sponsor ID
- ARPEGGIO / 25-708
- Keywords
- POSLUMA, prostate-specific membrane antigen positron-emission tomography, PSMA-PET/CT, 18F-flotufolastat-PSMA-PET/CT scan, ADT and 18F-flotufolastat-guided focal SBRT microboost, androgen deprivation therapy and 18F-flotufolastat-guided focal SBRT microboost, neoadjuvant ADT, neoadjuvant androgen deprivation therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Martin T. King, MD, PhDUniversity, hospital or other
- Collaborators
- Blue Earth Diagnostics, Dana-Farber/Brigham and Women's Cancer Center
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 6 Feb 2026 (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 research study is for men with intermediate- or high-risk prostate cancer who are planning to receive hormone therapy and radiation treatment. The purpose of the study is to see whether a special type of diagnostic imaging done during hormone therapy can help doctors more accurately target remaining cancer with radiation, while avoiding areas that may no longer need extra treatment. All participants will receive standard hormone therapy and radiation therapy, along with three imaging scans, over a six-month period. The information gained from this study may help make prostate cancer radiation treatment more precise and reduce side effects for future patients.
Detailed description
Prostate cancer is commonly treated with a combination of hormone therapy and radiation therapy. Hormone therapy, or androgen deprivation therapy (ADT), lowers testosterone levels and often shrinks or weakens prostate cancer before radiation begins. However, after hormone therapy starts, it can become harder for doctors to tell exactly where active cancer remains inside the prostate using standard imaging (typically an MRI). This study is being conducted to determine whether a newer imaging test can better identify which parts of the cancer are still active and may benefit from more focused radiation treatment.
All participants in this study will receive six months of ADT, which is part of standard care for intermediate- and high-risk prostate cancer. In addition, participants will undergo PSMA PET/CT scans, a type of imaging that highlights prostate cancer cells, as well as MRI scans. These scans will be performed at three time-points: before hormone therapy begins, approximately eight weeks after starting hormone therapy (before radiation planning), and again at 24 weeks (at the end of all treatment) to see how the cancer has responded to treatment.
Radiation therapy will begin shortly after the eight-week imaging scan. Participants will receive high-precision radiation (stereotactic body radiation therapy/SBRT) to the prostate over about two weeks. Based on the imaging results, doctors may give an extra "boost" of radiation to small areas that still show signs of active cancer. If the scans show that the cancer has responded well to hormone therapy, some patients may not need this extra boost. This approach is designed to deliver the strongest treatment where it is needed while limiting radiation to healthy tissue in order to minimize side effects.
The main goal of the study is to understand whether doctors can confidently use the mid-treatment PSMA PET/CT scan to guide radiation planning. Researchers will also monitor changes in PSA blood levels, imaging findings, treatment side effects, and patient-reported quality of life, including urinary, bowel, and sexual symptoms. Additionally, doctors participating in the study will provide feedback on how easy or difficult it is to define radiation target areas using the different scans.
Participation in this study lasts about 6 months, and all treatments provided are commonly used in prostate cancer care, with the incorporation of PSMA PET scans being the experimental component. While participants may or may not directly benefit, the results obtained from this study may help improve how radiation therapy is planned and delivered for future patients with prostate cancer, with the goal of maintaining treatment effectiveness while reducing side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADT + SBRT + PSMA PET/CT Imaging | Experimental | Diagnostic Test: PSMA PET/CT, Drug: Androgen Deprivation Therapy (ADT) +/- bicalutamide, Radiation: Stereotactic Body Radiation Therapy (SBRT) +/- focal microboost* ADT as prescribed * PSMA PET/CT imaging will be completed at baseline, 8 weeks after ADT start, and at end of treatment * SBRT is administered starting 10 weeks after ADT start |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age and older.
- Eastern Oncology Group Status 0 to 1.
- Histologic diagnosis of prostate cancer.
- Prior screening MRI with at least one PI-RADS4 or PI-RADS 5 lesion, obtained within 180 days of screening.
- NCCN intermediate-risk or high-risk prostate cancer (Appendix B). All patients will be staged by MRI.
Key exclusion criteria (12 listed)
- Prior imaging (CT, bone scan, MRI, PSMA-PET/CT) showing nodal or distant disease.
- Intention to receive treatment intensification with secondary androgen receptor signaling inhibitors or chemotherapy.
- Clinical T4 disease.
- Prior ADT.
- Prior pelvic RT.
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 |
|---|---|---|
| PSMA PET/CTPSMA PET/CT is an imaging test that uses a radioactive tracer to highlight prostate cancer cells. Imaging will be performed at baseline, approximately eight weeks after starting ADT, and approximately 24 weeks after starting ADT (end of treatment). These scans are used to guide radiation treatment planning and assess treatment response. | Diagnostic test | ADT + SBRT + PSMA PET/CT Imaging |
| Androgen Deprivation Therapy (ADT) +/- bicalutamideADT is used to lower testosterone levels, which can slow or shrink prostate tumors. All participants will receive approximately six months of ADT starting before radiation therapy, using injectable or oral medications. Depending on the type of ADT, participants may also receive daily bicalutamide. Bicalutamide is categorized as an antiandrogen, which means it will block the effects of testosterone and work together with ADT to slow down or shrink prostate cancer. | Drug | ADT + SBRT + PSMA PET/CT Imaging |
| Stereotactic Body Radiation Therapy (SBRT) +/- focal microboostSBRT is a form of radiation therapy that delivers precise, high-dose radiation to the prostate over a short period of time. SBRT will be initiated 10 weeks after initiation of ADT and will be delivered in five sessions over two weeks. Based on PSMA PET/CT and MRI findings after initiation of ADT, some participants may receive an optional focal radiation microboost to areas of residual cancer. The microboost, if delivered, will be given during the same SBRT treatment sessions and will be limited by standard safety constraints. | Radiation | ADT + SBRT + PSMA PET/CT Imaging |
Primary outcome
Percentage of patients with GTV treatment contours that are highly concordant with GTV-combined interim.
Time frame: 8 weeks from initiation of hormone therapy/before start of radiation therapy
To evaluate whether >50% of patients will be treated utilizing GTV contours that are highly concordant with those from interim PET/MR scans (GTV-combined-interim) based on the dice coefficient
4 secondary outcomes
Geometric accuracies of GTV-Combined-Baseline and GTV-combined-interim contours
Time frame: 8 weeks from initiation of hormone therapy/before start of radiation therapy
PSA response
Time frame: 8 weeks from initiation of hormone therapy and 24 weeks from initiation of hormone therapy (end of treatment)
PSMA PET response
Time frame: 8 weeks from initiation of hormone therapy and 24 weeks from initiation of hormone therapy (end of treatment)
MRI ADC contrast ratio
Time frame: 8 weeks from initiation of hormone therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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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.
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
Milford, United States
Dana-Farber/Brigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital
Weymouth, United States
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PSMA PET/CT, Androgen Deprivation Therapy (ADT) +/- bicalutamide and Stereotactic Body Radiation Therapy (SBRT) +/- focal microboost in people with Intermediate Risk Prostate Cancer and High Risk Prostate Cancer, run by Martin T. King, MD, PhD at 4 sites 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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with GTV treatment contours that are highly concordant with GTV-combined interim. (time frame: 8 weeks from initiation of hormone therapy/before start of radiation therapy). 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 29 May 2026.