Prostate CancerPhase 2(RANGER)NCT07313241
Phase II Trial of PSA Response-based Androgen Deprivation Therapy and Nodal Coverage for Prostate Cancer Early Salvage Radiotherapy (RANGER)
A Phase 2 study testing Prostate Fossa Radiotherapy, Pelvic nodal Radiotherapy and Androgen Deprivation Therapy (ADT) in people with Prostate Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This Phase II, single arm study evaluates a PSA-response-adapted approach to salvage radiotherapy after radical prostatectomy for prostate cancer. All participants will receive hypo-fractionated stereotactic radiotherapy to the prostate fossa. At 5 weeks, biochemical response will be assessed. 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?
- Prostate Fossa Radiotherapy, Pelvic nodal Radiotherapy and Androgen Deprivation Therapy (ADT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2025to 14 Nov 2030
- 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
- Men aged ≥18 years with histologically confirmed prostate adenocarcinoma treated with prostatectomy in the localized setting within 10 years, with post-operative PSA (persistent or rising) of ≥0.05ng/mL.
- Radical prostatectomy ≥4 months prior to enrollment without nodal involvement (pN0 or pNx)
- Performance status ECOG 0-2
- No definite evidence of regional or distant metastatic disease by at least pelvic imaging within 90 days of registration. Equivocal findings are allowed at investigator discretion. Imaging is specified as follows:
- PSA>=0.2ng/mL: positron emission tomography (PET) with FDA-approved advanced imaging agent for prostate cancer (e.g. PSMA) required.
- PSA <0.2 n/gm: PET with above noted agents OR conventional CT or MRI at investigator discretion.
- All sexually active men must agree to use adequate contraception for the duration of study therapies and a period of 60 days thereafter. Should a female partner of a trial participant become pregnant or suspect she is pregnant while the subject is participating in this study, the patient should inform his treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Prior androgen deprivation therapy (ADT) > 3 months OR anti-androgen therapy (AAT) of > 30 days. For shorter courses of either, at least 30 day "wash out" period is required with confirmation of resolved castration of testosterone to >50ng/mL.
- Ongoing testosterone replacement therapy (TRT) with refusal to discontinue (must be stopped with demonstration of detectable PSA ≥0.05ng/mL and non-castrate testosterone >50ng/mL after 14 days of TRT cessation)
- Prior pelvic radiotherapy
- 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, in the opinion of the investigator, would limit compliance with study requirements.
- History of bladder neck or urethral stricture requiring procedural intervention.
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to actively interfere with the safety or efficacy assessments of this study in the investigator's view.
- Active inflammatory bowel disease requiring recurring systemic or steroid/enema therapy
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
UT Southwestern Medical Center-Dallas
Dallas, Texas, 75390
Sarah Neufeld, MS, Sarah.Neufeld@utsouthwestern.edu
About this study
Official title: Phase II Trial of PSA Response-based Androgen Deprivation Therapy and Nodal Coverage for Prostate Cancer Early Salvage Radiotherapy
This Phase II, single arm study evaluates a PSA-response-adapted approach to salvage radiotherapy after radical prostatectomy for prostate cancer. All participants will receive hypo-fractionated stereotactic radiotherapy to the prostate fossa. At 5 weeks, biochemical response will be assessed. responders will proceed to observation, while non responders will receive sequential pelvic nodal radiotherapy and 4 months of androgen deprivation therapy (ADT). The study aims to determine whether this response base approach achieves non inferior 2 year freedom from progression compared with historical outcomes using routine pelvic nodal radiotherapy and ADT in all patients.
Read the detailed description
After radical prostatectomy, many men experience biochemical recurrence despite having no visible metastatic disease. Standard salvage radiotherapy is effective but often includes universal use of androgen deprivation therapy and pelvic nodal radiotherapy, which may expose many patients to unnecessary toxicity.
The study evaluates a response adapted strategy using hypo fractionated or ultra hypo fractionated prostate fossa radiotherapy delivered on the Ethos adaptive radiotherapy platform. All participants will undergo 5 fractions of prostate fossa radiotherapy. At 5 weeks from treatment initiation, biochemical response will be defined as PSA <0.05 ng/mL or a 0.2 ng/mL decrease from pre-treatment PSA. Responders will undergo observation. Non responders will receive sequential pelvic nodal stereotactic radiotherapy in 5 fractions and a 4 month course of ADT.
Primary objective is to determine whether PSAA response adapted escalation achieves non inferior 2 year freedom from progression compared with historical control data. Secondary outcomes include patient reported hormonal, urinary, and bowel symptoms (EPIC-26), as well as physician graded gastrointestinal and genitourinary toxicities. Exploratory objectives include evaluating locoregional and distant failure.
This approach may reduce unnecessary toxicity for responders whole allowing early selective intensification for non responders, shortening total treatment duration for all patients.
- Conditions
- Prostate Cancer
- Being tested
- Prostate Fossa Radiotherapy, Pelvic nodal Radiotherapy, Androgen Deprivation Therapy (ADT)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate Fossa RadiotherapyRadiation
Stereotactic ultra hypofractionanted radiotherapy delivered to the prostate fossa using the Ethos online adaptive platform. Total dose of 32.5 Gy administered in 5 fractions over 2-4 weeks.
Pelvic nodal RadiotherapyRadiation
Sequential pelvic nodal radiotherapy delivered only to PSA non responders. Dose of 25 Gy given in 5 fractions over 4 weeks using the same stereotactic technique as prostate fossa RT.
Androgen Deprivation Therapy (ADT)Drug
GnRH agonist or antagonist (leuprolide, goserelin, degarelix) administered as per institutional standard. Therapy duration is 4 months, starting before or within 14 days of pelvic nodal RT initiation.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm: PSA Response Adapted Salvage Radiotherapy | Experimental | All participants initially receive prostate fossa radiotherapy (RT) using stereotactic ultra-hypofractionated dosing (32.5 Gy in 5 fractions over 2-4 weeks) delivered via the Ethos™ online adaptive platform.
At approximately 5 weeks post-RT initiation, PSA response is assessed:
* Responders: Patients with PSA <0.05 ng/mL or a decrease of ≥0.2 ng/mL compared to pre-RT PSA will undergo observation without further immediate therapy.
* Non-Responders: Patients not meeting response criteria will receive sequential pelvic nodal RT (25 Gy in 5 fractions over ≤4 weeks) plus androgen deprivation therapy (ADT) for 4 months. Pelvic nodal RT begins within 14 days after response assessment. ADT (GnRH agonists/antagonists, e.g., leuprolide, goserelin, degarelix) will be started before or within 14 days of pelvic nodal RT initiation. Receives: Radiation: Prostate Fossa Radiotherapy; Radiation: Pelvic nodal Radiotherapy; Drug: Androgen Deprivation Therapy (ADT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from failure
first occurrence of rise of PSA of 2 ng/dL above post-salvage RT nadir, clinical progression (local/regional/distant) or death due to any cause.
Measured: 2 years from end of radiotherapy
Secondary outcomes (4)
EPIC-26 hormonal summary domain score
Patient reported hormonal symptom severity measure by the EPIC-26 questionnaire
Measured: Baseline and regular intervals during 2 year follow up
EPIC-26 Genitourinary (GU) summary domain score
Patient reported genitourinary symptom severity measure by EPIC-26
Measured: Baseline and regular intervals during 2 year follow up
EPIC-26 Gastrointestinal (GI) summary domain score
Patient reported gastrointestinal severity measured by EPIC-26
Measured: Baseline and regular intervals during 2 year follow up
CTCAE v5.0 toxicity GU and GI
GI and GU adverse events will be assessed and graded according to the National Cancer Institute Common Technology Criteria for Adverse Events (CTCAE), version 5.0.
Measured: Baseline and regular intervals during 2 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start14 Nov 2025
- Primary completion14 Nov 2030 (estimated)
- Study completion14 Nov 2030 (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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aurelie Garant, University of Texas Southwestern Medical Center
- Investigators
- Aurelie Garant, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313241
- Sponsor's protocol ID
- 20251220
- Acronym
- (RANGER)
- Status last verified
- Jun 2026
- First submitted
- 16 Dec 2025
- Last updated
- 30 Jun 2026
- 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 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of PSA Response-based Androgen Deprivation Therapy and Nodal Coverage for Prostate Cancer Early Salvage Radiotherapy
- ClinicalTrials.gov ID
- NCT07313241
- Acronym / sponsor ID
- (RANGER) / 20251220
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 14 Nov 2030 (estimated)
- Study completion
- 14 Nov 2030 (estimated)
- First posted
- 31 Dec 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.
This Phase II, single arm study evaluates a PSA-response-adapted approach to salvage radiotherapy after radical prostatectomy for prostate cancer. All participants will receive hypo-fractionated stereotactic radiotherapy to the prostate fossa. At 5 weeks, biochemical response will be assessed. responders will proceed to observation, while non responders will receive sequential pelvic nodal radiotherapy and 4 months of androgen deprivation therapy (ADT). The study aims to determine whether this response base approach achieves non inferior 2 year freedom from progression compared with historical outcomes using routine pelvic nodal radiotherapy and ADT in all patients.
Detailed description
After radical prostatectomy, many men experience biochemical recurrence despite having no visible metastatic disease. Standard salvage radiotherapy is effective but often includes universal use of androgen deprivation therapy and pelvic nodal radiotherapy, which may expose many patients to unnecessary toxicity.
The study evaluates a response adapted strategy using hypo fractionated or ultra hypo fractionated prostate fossa radiotherapy delivered on the Ethos adaptive radiotherapy platform. All participants will undergo 5 fractions of prostate fossa radiotherapy. At 5 weeks from treatment initiation, biochemical response will be defined as PSA <0.05 ng/mL or a 0.2 ng/mL decrease from pre-treatment PSA. Responders will undergo observation. Non responders will receive sequential pelvic nodal stereotactic radiotherapy in 5 fractions and a 4 month course of ADT.
Primary objective is to determine whether PSAA response adapted escalation achieves non inferior 2 year freedom from progression compared with historical control data. Secondary outcomes include patient reported hormonal, urinary, and bowel symptoms (EPIC-26), as well as physician graded gastrointestinal and genitourinary toxicities. Exploratory objectives include evaluating locoregional and distant failure.
This approach may reduce unnecessary toxicity for responders whole allowing early selective intensification for non responders, shortening total treatment duration for all patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm: PSA Response Adapted Salvage Radiotherapy | Experimental | Radiation: Prostate Fossa Radiotherapy, Radiation: Pelvic nodal Radiotherapy, Drug: Androgen Deprivation Therapy (ADT)All participants initially receive prostate fossa radiotherapy (RT) using stereotactic ultra-hypofractionated dosing (32.5 Gy in 5 fractions over 2-4 weeks) delivered via the Ethos™ online adaptive platform. At approximately 5 weeks post-RT initiation, PSA response is assessed: * Responders: Patients with PSA <0.05 ng/mL or a decrease of ≥0.2 ng/mL compared to pre-RT PSA will undergo observation without further immediate therapy. * Non-Responders: Patients not meeting response criteria will receive sequential pelvic nodal RT (25 Gy in 5 fractions over ≤4 weeks) plus androgen deprivation therapy (ADT) for 4 months. Pelvic nodal RT begins within 14 days after response assessment. ADT (GnRH agonists/antagonists, e.g., leuprolide, goserelin, degarelix) will be started before or within 14 days of pelvic nodal RT initiation. |
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)
- Men aged ≥18 years with histologically confirmed prostate adenocarcinoma treated with prostatectomy in the localized setting within 10 years, with post-operative PSA (persistent or rising) of ≥0.05ng/mL.
- Radical prostatectomy ≥4 months prior to enrollment without nodal involvement (pN0 or pNx)
- Performance status ECOG 0-2
- No definite evidence of regional or distant metastatic disease by at least pelvic imaging within 90 days of registration. Equivocal findings are allowed at investigator discretion. Imaging is specified as follows:
- All sexually active men must agree to use adequate contraception for the duration of study therapies and a period of 60 days thereafter. Should a female partner of a trial participant become pregnant or suspect she is pregnant while the subject is participating in this study, the patient should inform his treating physician immediately.
Key exclusion criteria (7 listed)
- Prior androgen deprivation therapy (ADT) > 3 months OR anti-androgen therapy (AAT) of > 30 days. For shorter courses of either, at least 30 day "wash out" period is required with confirmation of resolved castration of testosterone to >50ng/mL.
- Ongoing testosterone replacement therapy (TRT) with refusal to discontinue (must be stopped with demonstration of detectable PSA ≥0.05ng/mL and non-castrate testosterone >50ng/mL after 14 days of TRT cessation)
- Prior pelvic radiotherapy
- 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, in the opinion of the investigator, would limit compliance with study requirements.
- History of bladder neck or urethral stricture requiring procedural intervention.
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 |
|---|---|---|
| Prostate Fossa RadiotherapyStereotactic ultra hypofractionanted radiotherapy delivered to the prostate fossa using the Ethos online adaptive platform. Total dose of 32.5 Gy administered in 5 fractions over 2-4 weeks. | Radiation | Single Arm: PSA Response Adapted Salvage Radiotherapy |
| Pelvic nodal RadiotherapySequential pelvic nodal radiotherapy delivered only to PSA non responders. Dose of 25 Gy given in 5 fractions over 4 weeks using the same stereotactic technique as prostate fossa RT. | Radiation | Single Arm: PSA Response Adapted Salvage Radiotherapy |
| Androgen Deprivation Therapy (ADT)GnRH agonist or antagonist (leuprolide, goserelin, degarelix) administered as per institutional standard. Therapy duration is 4 months, starting before or within 14 days of pelvic nodal RT initiation. | Drug | Single Arm: PSA Response Adapted Salvage Radiotherapy |
Primary outcome
Freedom from failure
Time frame: 2 years from end of radiotherapy
first occurrence of rise of PSA of 2 ng/dL above post-salvage RT nadir, clinical progression (local/regional/distant) or death due to any cause.
4 secondary outcomes
EPIC-26 hormonal summary domain score
Time frame: Baseline and regular intervals during 2 year follow up
EPIC-26 Genitourinary (GU) summary domain score
Time frame: Baseline and regular intervals during 2 year follow up
EPIC-26 Gastrointestinal (GI) summary domain score
Time frame: Baseline and regular intervals during 2 year follow up
CTCAE v5.0 toxicity GU and GI
Time frame: Baseline and regular intervals during 2 year follow up
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 30 Jun 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.
Aurelie Garant, 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 Phase 2 study testing Prostate Fossa Radiotherapy, Pelvic nodal Radiotherapy and Androgen Deprivation Therapy (ADT) in people with 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 7 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 30 Jun 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?
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?
Contact Sarah Neufeld, MS (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?
Freedom from failure (time frame: 2 years from end of radiotherapy). 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 30 Jun 2026.