Prostate Cancer (Adenocarcinoma)DE-CARTNCT07219303
Adaptive Radiation Therapy for Men With Intermediate- or High-Risk Prostate Cancer
A study testing adaptive stereotactic body radiation therapy (SBRT) with a SIB in people with Prostate Cancer (Adenocarcinoma), run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate if adaptive stereotactic body radiation therapy (SBRT) is a safe and effective way to treat prostate cancer in adults. It will assess the safety profile of adaptive SBRT over time. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma)
- What is being tested?
- adaptive stereotactic body radiation therapy (SBRT) with a SIB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2025to 1 Nov 2033
- Phase
- Interventional
- 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
- Subjects must have histologically confirmed intermediate- and favorable high risk (AJCC 8th ed stage IIA-IIC) adenocarcinoma of the prostate.
- Age > 18 years.
- ECOG performance status ≤ 2
- Prostate volume (segmented) ≤ 100 cc determined by MRI and/or US within 24 mo of treatment for patients not on ADT and within 6 mo for patients on prior ADT. A simulation MRI is acceptable.
- Subjects must have had a pre-treatment diagnostic multiparametric MRI prostate (mpMRI) showing a PI-RADS3, 4 or 5 lesion or a 68Ga- or 18F-PSMA (TLX591-CDx or piflufolastat F18) PET/CT within 12 mo of study registration.
- Baseline International Prostate Symptom Score (IPSS) is ≤ 15. Baseline alpha blocker use is allowed.
- Subjects must have full capacity to understand and be willing to sign the informed consent document.
Who cannot join
- Subjects must not be experiencing toxicity CTCAE grade ≥ 3 GU or GI toxicity at baseline.
- Subjects must not be receiving any other investigational agents.
- Subjects must not have had prior pelvic radiation therapy.
- Subjects must not have node-positive disease.
- Subjects must not have extraprostatic extension determined by MRI prostate within 24 mo of treatment. For patients receiving ADT, the prostate MRI must have been obtained prior to the start of ADT.
- Subjects must not have had prior ablative therapies for prostate cancer including cryosurgery, HIFU and nanoknife.
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- Subjects with prior TURP or laser enucleation are eligible. However, patients that have undergone prior simple prostatectomy are excluded.
- Subjects that are receiving other antineoplastic agents including methotrexate are ineligible. Subjects that have received prior ADT are eligible if they have received < 6 mo total of ADT, if last administration of ADT was > 6 mo prior to registration and serum total testosterone levels have recovered to at least 100 ng/dL. Subjects with prior cancer diagnoses are eligible provided that treatment was completed and no evidence of disease status achieved at least 2 years prior to study registration.
- Subjects must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Any condition or significant co-morbidity that prevents safe delivery of SBRT per the discretion of the treating physician(s).
- Subjects with active inflammatory bowel disease or active collagen vascular disorder.
- Subjects that cannot undergo prostate fiducial placement.
- Subjects that cannot undergo rectal spacer placement are excluded. Please, note that a rectal spacer incorporating iodine or similar CT contrast is preferred. However, patients that are able to only have a non-contrast rectal spacer due to iodine allergy or similar contraindication remain eligible.
- Subjects that cannot undergo prostate MRI.
- Subjects with bilateral prosthetic hips will be excluded. Subjects with unilateral prosthetic hips will be eligible only if the initial treatment plan meets all target and normal tissue constraints without protocol violation.
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, 1 recruiting
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Mark A Hallman, MD, PhD, 215-728-2581, Mark.Hallman@fccc.edu
About this study
Official title: Dose Escalated CT-Based Adaptive Stereotactic Body Radiation Therapy Among Patients With Intermediate- and Favorable High- Risk Prostate Cancer (DE-CART)
The goal of this clinical trial is to evaluate if adaptive stereotactic body radiation therapy (SBRT) is a safe and effective way to treat prostate cancer in adults. It will assess the safety profile of adaptive SBRT over time.
The main questions this trial aims to answer are:
Read more
- What is highest dose of adaptive SBRT without causing serious side effects?
- Can adaptive SBRT more precisely targeting the prostate while reducing radiation exposure to nearby organs?
- What side effects do participants experience during treatment, right after treatment, and over the five years post-treatment?
- Can adaptive SBRT reduce urination-related side effects and support quality of life during and after treatment?
Participants will:
- Receive adaptive SBRT treatment every other day, for a total of 5 treatment sessions (called fractions). The full course of treatment typically takes 2 to 3 weeks.
- Have a follow-up phone call about 6 weeks after treatment to check on side effects and overall wellbeing.
- Visit the clinic for check-ups and tests:
- At 90 days (about 3 months) after treatment
- Then every 3 months for the first year
- Then every 6 months after that
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Being tested
- adaptive stereotactic body radiation therapy (SBRT) with a SIB
- Keywords
- Adaptive, SBRT, Stereotactic body radiation therapy, QOL, Simultaneous integrated boost, SIB, Adenocarcinoma, Prostate Cancer, Prostate Neoplasms
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adaptive stereotactic body radiation therapy (SBRT) with a SIBRadiation
This is a phase 1 dose finding study investigating escalated doses of adaptive prostate SBRT for patients with intermediate and favorable high risk prostate cancer. There will be a Bayseian Optimal Interval Design (BOIN) defining the dose escalation parameters and the dose will escalate as per Section 5.0. Treatment is 5 fractions every other day and will be expected to be typically completed in 2-3 calendar weeks.
| Study group | Role | What they receive |
|---|---|---|
| Phase I Dose escalated adaptive stereotactic body radiation therapy (SBRT) with a SIB | Experimental | Not described Receives: Radiation: adaptive stereotactic body radiation therapy (SBRT) with a SIB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe (CTCAE grade ≥ 3) treatment-related (possibly, probably or definitely) toxicity occurring within 90 days of treatment.
Measured: From initiation of treatment to 90 days after end of treatment, for a duration of ~100 days.
Secondary outcomes (7)
Biochemically progression free survival
Time from the end of treatment administration to biochemical progression (using Pheonix definition), local, regional, or distant progression, initiation of additional prostate cancer therapy, or death. Patients who are alive and have not experienced any progression or initiated any additional prostate cancer therapy by the end of follow up are considered censored.
Measured: From end of treatment to biochemical, local, regional or distant progression, or initiation of additional prostate cancer therapy or death, or end of follow up for a total of up to 5 years.
Local failure free survival
Time from the end of treatment administration to local progression or death. Patients who are still alive and have not had local progression by the end of follow up are considered censored.
Measured: From end of treatment to local progression or death or end of follow up for a total of up to 5 years.
PSA response
The PSA response will be assessed by the post-treatment PSA nadir and time to nadir.
Measured: From end of treatment to end of follow-up for a total of up to 5 years.
The proportion of patients who have a decrease greater than or equal to the acute minimum clinically important difference (MID) in EPIC-26 scores among the urinary, bowel and sexual function domains at 3 and 6 months post-treatment compared to baseline
Measured: From enrollment to 6 months post-treatment.
The proportion of patients who have a decrease greater than or equal to the minimum clinically important difference (MID) in EPIC-26 scores among the urinary, bowel and sexual function domains at 1 and 2 years post-treatment compared to baseline.
Measured: From enrollment to 2 years post-treatment for a duration of ~ 2.5 years.
Distant metastasis free survival
Time from the end of treatment administration to distant metastasis or death. Patients who are still alive and metastasis-free at the end of follow up are considered censored.
Measured: From end of treatment to distant metastasis or death or end of follow up, for a total of up to 5 years.
The proportion of patients who had at least one optimal treatment planning criteria not met, the number of criteria not met per patient, and the number of criteria not met per organ site.
These proportions will be assessed in the overall population and per dose level.
Measured: From radiation simulation to end of treatment for a duration of 2-3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start25 Sep 2025
- Primary completion1 Aug 2033 (estimated)
- Study completion1 Nov 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark A Hallman, MD, PhD, Principal investigator, FCCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219303
- Sponsor's protocol ID
- RT-237
- Other IDs
- 25-1023
- Acronym
- DE-CART
- Status last verified
- Oct 2025
- First submitted
- 16 Sep 2025
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Escalated CT-Based Adaptive Stereotactic Body Radiation Therapy Among Patients With Intermediate- and Favorable High- Risk Prostate Cancer (DE-CART)
- ClinicalTrials.gov ID
- NCT07219303
- Acronym / sponsor ID
- DE-CART / RT-237
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Keywords
- Adaptive, SBRT, Stereotactic body radiation therapy, QOL, Simultaneous integrated boost, SIB, Adenocarcinoma, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 1 Aug 2033 (estimated)
- Study completion
- 1 Nov 2033 (estimated)
- First posted
- 21 Oct 2025 (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 goal of this clinical trial is to evaluate if adaptive stereotactic body radiation therapy (SBRT) is a safe and effective way to treat prostate cancer in adults. It will assess the safety profile of adaptive SBRT over time.
The main questions this trial aims to answer are:
- What is highest dose of adaptive SBRT without causing serious side effects?
- Can adaptive SBRT more precisely targeting the prostate while reducing radiation exposure to nearby organs?
- What side effects do participants experience during treatment, right after treatment, and over the five years post-treatment?
- Can adaptive SBRT reduce urination-related side effects and support quality of life during and after treatment?
Participants will:
- Receive adaptive SBRT treatment every other day, for a total of 5 treatment sessions (called fractions). The full course of treatment typically takes 2 to 3 weeks.
- Have a follow-up phone call about 6 weeks after treatment to check on side effects and overall wellbeing.
- Visit the clinic for check-ups and tests:
- At 90 days (about 3 months) after treatment
- Then every 3 months for the first year
- Then every 6 months after that
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase I Dose escalated adaptive stereotactic body radiation therapy (SBRT) with a SIB | Experimental | Radiation: adaptive stereotactic body radiation therapy (SBRT) with a SIB |
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)
- Subjects must have histologically confirmed intermediate- and favorable high risk (AJCC 8th ed stage IIA-IIC) adenocarcinoma of the prostate.
- Age > 18 years.
- ECOG performance status ≤ 2
- Prostate volume (segmented) ≤ 100 cc determined by MRI and/or US within 24 mo of treatment for patients not on ADT and within 6 mo for patients on prior ADT. A simulation MRI is acceptable.
- Subjects must have had a pre-treatment diagnostic multiparametric MRI prostate (mpMRI) showing a PI-RADS3, 4 or 5 lesion or a 68Ga- or 18F-PSMA (TLX591-CDx or piflufolastat F18) PET/CT within 12 mo of study registration.
Key exclusion criteria (15 listed)
- Subjects must not be experiencing toxicity CTCAE grade ≥ 3 GU or GI toxicity at baseline.
- Subjects must not be receiving any other investigational agents.
- Subjects must not have had prior pelvic radiation therapy.
- Subjects must not have node-positive disease.
- Subjects must not have extraprostatic extension determined by MRI prostate within 24 mo of treatment. For patients receiving ADT, the prostate MRI must have been obtained prior to the start of ADT.
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 |
|---|---|---|
| adaptive stereotactic body radiation therapy (SBRT) with a SIBThis is a phase 1 dose finding study investigating escalated doses of adaptive prostate SBRT for patients with intermediate and favorable high risk prostate cancer. There will be a Bayseian Optimal Interval Design (BOIN) defining the dose escalation parameters and the dose will escalate as per Section 5.0. Treatment is 5 fractions every other day and will be expected to be typically completed in 2-3 calendar weeks. | Radiation | Phase I Dose escalated adaptive stereotactic body radiation therapy (SBRT) with a SIB |
Primary outcome
Severe (CTCAE grade ≥ 3) treatment-related (possibly, probably or definitely) toxicity occurring within 90 days of treatment.
Time frame: From initiation of treatment to 90 days after end of treatment, for a duration of ~100 days.
7 secondary outcomes
Biochemically progression free survival
Time frame: From end of treatment to biochemical, local, regional or distant progression, or initiation of additional prostate cancer therapy or death, or end of follow up for a total of up to 5 years.
Local failure free survival
Time frame: From end of treatment to local progression or death or end of follow up for a total of up to 5 years.
PSA response
Time frame: From end of treatment to end of follow-up for a total of up to 5 years.
The proportion of patients who have a decrease greater than or equal to the acute minimum clinically important difference (MID) in EPIC-26 scores among the urinary, bowel and sexual function domains at 3 and 6 months post-treatment compared to baseline
Time frame: From enrollment to 6 months post-treatment.
The proportion of patients who have a decrease greater than or equal to the minimum clinically important difference (MID) in EPIC-26 scores among the urinary, bowel and sexual function domains at 1 and 2 years post-treatment compared to baseline.
Time frame: From enrollment to 2 years post-treatment for a duration of ~ 2.5 years.
Distant metastasis free survival
Time frame: From end of treatment to distant metastasis or death or end of follow up, for a total of up to 5 years.
The proportion of patients who had at least one optimal treatment planning criteria not met, the number of criteria not met per patient, and the number of criteria not met per organ site.
Time frame: From radiation simulation to end of treatment for a duration of 2-3 months.
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 Oct 2025.
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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.
Mark A Hallman, MD, PhD principal investigator
FCCC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adaptive stereotactic body radiation therapy (SBRT) with a SIB in people with Prostate Cancer (Adenocarcinoma), run by Fox Chase Cancer 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 7 inclusion and 15 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 Oct 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.
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 Mark A Hallman, MD, PhD (215-728-2581, Mark.Hallman@fccc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe (CTCAE grade ≥ 3) treatment-related (possibly, probably or definitely) toxicity occurring within 90 days of treatment. (time frame: From initiation of treatment to 90 days after end of treatment, for a duration of ~100 days.). 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 Oct 2025.