Prostate CancerEarly Phase 1RIPCORDNCT07674771
Response With Interim PSMA PET in Metastatic Castration-sensitive Prostate Cancer for Optimization of Adaptive Metastasis-directed Radiotherapy Delivery
A Early Phase 1 study testing Drug: 68-Ga PSMA11, Adaptive stereotactic ablative radiotherapy (SABR) and 68Ga-PSMA-11 in people with Prostate Cancer and Castration Sensitive Prostate Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to characterize the reduction in PSMA-avid tumor volume and metastasis-directed radiotherapy treatment intensity facilitated by PET PSMA-response adapted SABR for poly-metastatic castration sensitive prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Castration Sensitive Prostate Cancer, Metastatic Prostate Cancer
- What is being tested?
- Drug: 68-Ga PSMA11, Adaptive stereotactic ablative radiotherapy (SABR) and 68Ga-PSMA-11
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to 15 Jun 2029
- Phase
- Early Phase 1
- 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
- History of pathologically confirmed prostate cancer.
- Age >=18 years.
- Performance status ECOG 0-2.
- Staging 68Ga PMSA-11 PET/CT showing 4-20 sites of metastasis from prostate cancer within <=90 days prior to registration. This scan ideally should be performed before initiation of androgen deprivation therapy (ADT).
- At the discretion of the treating investigator, it is believed that it is safe to treat all sites of disease using SABR.
- All men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of standard of care SABR and for a period of time of 6 months thereafter as per standard guidelines. Should a patient's partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent.
- Planned for standard systemic therapy for metastatic prostate cancer to include androgen deprivation therapy (ADT). Upfront Docetaxel should not be planned (See section 4.1.2).
Who cannot join
- Prior radiotherapy to any metastases currently targeted for therapy or overlapping regions.
- Patient with metastatic lesions involving the gastrointestinal tract, specifically, invading esophagus, stomach, or intestines will be excluded. Patients with ultra-central metastatic lesions defined as 1 cm from the trachea and main bronchi will be excluded.
- Serious medical co-morbidities precluding safe delivering of radiotherapy to poly-metastatic sites. This includes interstitial lung disease for patients undergoing SABR to thoracic sites and ulcerative colitis or Crohn's disease requiring systemic immunosuppressive therapy for patients undergoing SABR to GI sites.
- Subjects may not be receiving any other PSMA-directed investigational agents for the treatment of the cancer under study.
- History of allergic reactions to PMSA-11 68Ga imaging agent.
- Uncontrolled intercurrent illness or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
SARAH NEUFELD, SUPERVISOR OF CLINICAL RESEARCH, MS, MBA, 214 648 1836, Sarah.Hardee@UTSouthwestern.edu
LILIANA ROBLES, 214 645 5354, LILIANA.ROBLES@UTSouthwestern.edu
About this study
The purpose of this study is to characterize the reduction in PSMA-avid tumor volume and metastasis-directed radiotherapy treatment intensity facilitated by PET PSMA-response adapted SABR for poly-metastatic castration sensitive prostate cancer.
Read the detailed description
This study will enroll patients with poly-metastatic hormone-sensitive prostate cancer, as identified by baseline PSMA PET imaging. All participants will undergo standard of care systemic therapy, including ADT and androgen receptor signaling inhibitors intensification as clinically indicated, for up to three months before protocol radiotherapy. The treating radiation oncologist will pre-plan SABR to a total of 35-40 Gy in 5 fractions. The study will consist of initially delivering three qWeekly SABR "pulses" to all identified metastatic sites. The initial pulse should start within 60 (+/-30 days) of initiation of ADT. Following the third pulse, interim PSMA PET imaging will be repeated at 6 months from initiation of ADT (-30 days allowed) to evaluate the response on a per lesion basis (See Section 6.1.2.1). In the absence of a complete response (CR) for a given lesion, two additional qWeekly pulses may be delivered to these sites within 60 days from interim PSMA PET. PSMA avid lesions identified at baseline will be monitored on interim and follow up scan, and new PSMA avid lesions will require confirmation through conventional imaging. If patients exhibit progression on PSA or conventional imaging, they will exit the trial and undergo systemic therapy intensification. More detailed specifications on systemic therapy and SABR and their parameters are provided in the protocol.
- Conditions
- Prostate Cancer, Castration Sensitive Prostate Cancer, Metastatic Prostate Cancer, Adaptive Radiotherapy
- Being tested
- Drug: 68-Ga PSMA11, Adaptive stereotactic ablative radiotherapy (SABR), 68Ga-PSMA-11, Adaptive stereotactive ablative radiotherapy (SABR)
- Keywords
- prostate cancer, castration sensitive, stereotactic ablative radiotherapy, stereotactic body radiotherapy, metastatic prostate cancer, metastasis, adaptive radiotherapy
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: 68-Ga PSMA11Drug
0-3 months since initiation of ADT. Baseline PSMA PET imaging. 4-20 sites of metastasis by PSMA PET Will be injected/assessed in line with its FDA label.
Other Name:
Adaptive stereotactic ablative radiotherapy (SABR)Radiation
Pre-plan 5 fraction SABR 35-40 Gy. SOC systemic therapy allows for ADT and ARSI intensification. Delivery of 3 pulses to all sites. Pulses delivered weekly.
68Ga-PSMA-11Drug
Repeat PSMA PET imaging at 6 months post-ADT initiation. Radiation of primary allows. Will be injected/assessed in line with its FDA label.
Adaptive stereotactive ablative radiotherapy (SABR)Radiation
Delivery of 2 additional pulses to all remaining PSMA PET visible sites
| Study group | Role | What they receive |
|---|---|---|
| SINGLE ARM UNBLINDED SINGLE SITE PILOT | Experimental | Study will enroll patients with poly-metastatic hormone-sensitive prostate cancer, as identified by baseline PSMA PET imaging.Patients will undergo standard of care systemic therapy,including ADT \& androgen receptor signaling inhibitors intensification as clinically indicated,for up to 3 months before protocol radiotherapy. Receives: Drug: Drug: 68-Ga PSMA11; Radiation: Adaptive stereotactic ablative radiotherapy (SABR); Drug: 68Ga-PSMA-11; Radiation: Adaptive stereotactive ablative radiotherapy (SABR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in PSMA-positive TTV
will be measured by the decrease in TTV (%) on a per-patient basis between the initial scan and post-SABR PSMA PET.
Measured: 1 YEAR
Reduction in SABR treatment intensity
Will be measured by the decrease in proportion of tumor lesions treated to initially prescribed 5 fractions (%) due specifically to complete metabolic response on interim PET PSMA after 3 fractions, as compared to initially planned lesions on a per patient basis.
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study startOct 2026 (estimated)
- Primary completion15 Jun 2029 (estimated)
- Study completion15 Jun 2029 (estimated)
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 University of Texas Southwestern Medical CenterThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 1 site pilot study with intent to characterize dynamic range of response by PET PSMA-11 68Ga characterization of poly-metastatic prostate cancer lesions \& safe delivery of comprehensive SABR using adaption based on PSMA metabolic response.Patients will undergo standard of care therapy, including ADT \& androgen receptor signaling inhibitors intensification as clinically indicated,for up to 3 months before protocol radiotherapy.The radiation oncologist will pre-plan SABR to a total of 35-40 Gy in 5 fractions. Trial will consist of initially delivering 3 qWeekly SABR "pulses" to all identified metastatic sites.First pulse should start within 60 (+/-30 days)of start of ADT. Following pulse 3,interim PSMA PET imaging to be repeated at 6 months from initiation of ADT(-30 days allowed)to evaluate response on a per lesion basis.In the absence of a complete response (CR) for a given lesion,2 additional qWeekly pulses may be delivered to these sites within 60 days from interim PSMA PET.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Varian, a Siemens Healthineers Company, Telix Pharmaceuticals (Innovations) Pty Ltd
- Responsible party
- Principal investigator, Daniel Yang, University of Texas Southwestern Medical Center
- Investigators
- DANIEL YANG, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674771
- Sponsor's protocol ID
- STU 20260850
- Acronym
- RIPCORD
- Status last verified
- Aug 2026
- First submitted
- 24 Jun 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response With Interim PSMA PET in Metastatic Castration-sensitive Prostate Cancer for Optimization of Adaptive Metastasis-directed Radiotherapy Delivery
- ClinicalTrials.gov ID
- NCT07674771
- Acronym / sponsor ID
- RIPCORD / STU 20260850
- Conditions
- Prostate Cancer, Castration Sensitive Prostate Cancer, Metastatic Prostate Cancer, Adaptive Radiotherapy
- Keywords
- prostate cancer, castration sensitive, stereotactic ablative radiotherapy, stereotactic body radiotherapy, metastatic prostate cancer, metastasis, adaptive radiotherapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Varian, a Siemens Healthineers Company, Telix Pharmaceuticals (Innovations) Pty Ltd
- Study start
- Oct 2026 (estimated)
- Primary completion
- 15 Jun 2029 (estimated)
- Study completion
- 15 Jun 2029 (estimated)
- First posted
- 30 Jun 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.
The purpose of this study is to characterize the reduction in PSMA-avid tumor volume and metastasis-directed radiotherapy treatment intensity facilitated by PET PSMA-response adapted SABR for poly-metastatic castration sensitive prostate cancer.
Detailed description
This study will enroll patients with poly-metastatic hormone-sensitive prostate cancer, as identified by baseline PSMA PET imaging. All participants will undergo standard of care systemic therapy, including ADT and androgen receptor signaling inhibitors intensification as clinically indicated, for up to three months before protocol radiotherapy. The treating radiation oncologist will pre-plan SABR to a total of 35-40 Gy in 5 fractions. The study will consist of initially delivering three qWeekly SABR "pulses" to all identified metastatic sites. The initial pulse should start within 60 (+/-30 days) of initiation of ADT. Following the third pulse, interim PSMA PET imaging will be repeated at 6 months from initiation of ADT (-30 days allowed) to evaluate the response on a per lesion basis (See Section 6.1.2.1). In the absence of a complete response (CR) for a given lesion, two additional qWeekly pulses may be delivered to these sites within 60 days from interim PSMA PET. PSMA avid lesions identified at baseline will be monitored on interim and follow up scan, and new PSMA avid lesions will require confirmation through conventional imaging. If patients exhibit progression on PSA or conventional imaging, they will exit the trial and undergo systemic therapy intensification. More detailed specifications on systemic therapy and SABR and their parameters are provided in the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 1 site pilot study with intent to characterize dynamic range of response by PET PSMA-11 68Ga characterization of poly-metastatic prostate cancer lesions \& safe delivery of comprehensive SABR using adaption based on PSMA metabolic response.Patients will undergo standard of care therapy, including ADT \& androgen receptor signaling inhibitors intensification as clinically indicated,for up to 3 months before protocol radiotherapy.The radiation oncologist will pre-plan SABR to a total of 35-40 Gy in 5 fractions. Trial will consist of initially delivering 3 qWeekly SABR "pulses" to all identified metastatic sites.First pulse should start within 60 (+/-30 days)of start of ADT. Following pulse 3,interim PSMA PET imaging to be repeated at 6 months from initiation of ADT(-30 days allowed)to evaluate response on a per lesion basis.In the absence of a complete response (CR) for a given lesion,2 additional qWeekly pulses may be delivered to these sites within 60 days from interim PSMA PET.
| Arm | Type | Receives |
|---|---|---|
| SINGLE ARM UNBLINDED SINGLE SITE PILOT | Experimental | Drug: Drug: 68-Ga PSMA11, Radiation: Adaptive stereotactic ablative radiotherapy (SABR), Drug: 68Ga-PSMA-11, Radiation: Adaptive stereotactive ablative radiotherapy (SABR)Study will enroll patients with poly-metastatic hormone-sensitive prostate cancer, as identified by baseline PSMA PET imaging.Patients will undergo standard of care systemic therapy,including ADT \& androgen receptor signaling inhibitors intensification as clinically indicated,for up to 3 months before protocol radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- History of pathologically confirmed prostate cancer.
- Age >=18 years.
- Performance status ECOG 0-2.
- Staging 68Ga PMSA-11 PET/CT showing 4-20 sites of metastasis from prostate cancer within <=90 days prior to registration. This scan ideally should be performed before initiation of androgen deprivation therapy (ADT).
- At the discretion of the treating investigator, it is believed that it is safe to treat all sites of disease using SABR.
Key exclusion criteria (6 listed)
- Prior radiotherapy to any metastases currently targeted for therapy or overlapping regions.
- Patient with metastatic lesions involving the gastrointestinal tract, specifically, invading esophagus, stomach, or intestines will be excluded. Patients with ultra-central metastatic lesions defined as 1 cm from the trachea and main bronchi will be excluded.
- Serious medical co-morbidities precluding safe delivering of radiotherapy to poly-metastatic sites. This includes interstitial lung disease for patients undergoing SABR to thoracic sites and ulcerative colitis or Crohn's disease requiring systemic immunosuppressive therapy for patients undergoing SABR to GI sites.
- Subjects may not be receiving any other PSMA-directed investigational agents for the treatment of the cancer under study.
- History of allergic reactions to PMSA-11 68Ga imaging agent.
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 |
|---|---|---|
| Drug: 68-Ga PSMA110-3 months since initiation of ADT. Baseline PSMA PET imaging. 4-20 sites of metastasis by PSMA PET Will be injected/assessed in line with its FDA label. Other Name: | Drug | SINGLE ARM UNBLINDED SINGLE SITE PILOT |
| Adaptive stereotactic ablative radiotherapy (SABR)Pre-plan 5 fraction SABR 35-40 Gy. SOC systemic therapy allows for ADT and ARSI intensification. Delivery of 3 pulses to all sites. Pulses delivered weekly. | Radiation | SINGLE ARM UNBLINDED SINGLE SITE PILOT |
| 68Ga-PSMA-11Repeat PSMA PET imaging at 6 months post-ADT initiation. Radiation of primary allows. Will be injected/assessed in line with its FDA label. | Drug | SINGLE ARM UNBLINDED SINGLE SITE PILOT |
| Adaptive stereotactive ablative radiotherapy (SABR)Delivery of 2 additional pulses to all remaining PSMA PET visible sites | Radiation | SINGLE ARM UNBLINDED SINGLE SITE PILOT |
Primary outcome
Reduction in PSMA-positive TTV
Time frame: 1 YEAR
will be measured by the decrease in TTV (%) on a per-patient basis between the initial scan and post-SABR PSMA PET.
Reduction in SABR treatment intensity
Time frame: 1 YEAR
Will be measured by the decrease in proportion of tumor lesions treated to initially prescribed 5 fractions (%) due specifically to complete metabolic response on interim PET PSMA after 3 fractions, as compared to initially planned lesions on a per patient basis.
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 24 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
DANIEL YANG, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Drug: 68-Ga PSMA11, Adaptive stereotactic ablative radiotherapy (SABR) and 68Ga-PSMA-11 in people with Prostate Cancer and Castration Sensitive Prostate Cancer, run by University of Texas Southwestern Medical Center 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 8 inclusion and 6 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: opening soon, as of the sponsor's last update on 24 Aug 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Contact SARAH NEUFELD, MS, MBA (214 645 8525, sarah.hardee@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in PSMA-positive TTV (time frame: 1 YEAR). The study lists 2 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 24 Aug 2026.