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Prostate CancerPhase 1NCT02353819

Stereotactic Ablative Radiotherapy (SABR) of Pelvis and Prostate Targets For High Risk Prostate Cancer

A Phase 1 study testing Stereotactic Ablative Radiotherapy in people with Prostate Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Since high risk prostate cancer requires higher radiation, this study is being done to determine the maximum tolerated dose of radiation to the prostate and pelvic regions. Also to determine the feasibility and safety of each treatment fraction by using cone-beam Computed Tomography(CT) information and high speed… 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?
Stereotactic Ablative Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
Oct 2015to Dec 2030
Phase
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

  • Signed study specific informed consent form.
  • Patients must have at least one of the following criteria:
  • The serum PSA should be greater than or equal to 20 ng/ml OR
  • Study entry PSA must not be obtained during the following time frames following prostate biopsy: (2) following initiation of ADT.
  • The Gleason score should be greater than or equal to 8 OR
  • Eligible patients must have appropriate staging studies identifying them as AJCC stage T3+ adenocarcinoma of the prostate gland. (MR stage T3a without other high risk factors permitted at investigator discretion
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  • Male Patient past their 18th birthday at time of registration.
  • The patient's Zubrod performance status must be 0-2
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, and during radiation treatment.
  • All patients must be willing and capable to provide informed consent to participate in the protocol
  • Imaging studies can include, but is not limited to the following: ultrasound, CT of pelvis/prostate (abdomen recommended) and MRI of pelvis/prostate and (abdomen recommended)
  • The ultrasound, MRI or CT based volume estimation of the patient's prostate gland should not be greater than 80 grams (Repeat measurement after hormone downsizing allowed)
  • Clinically negative lymph nodes, within 90 days of study enrollment, established by imaging (pelvic/prostate (abdominal recommended) CT or MRI) OR by nodal sampling OR by dissection. Nodes > 2.0 cm should be biopsied. Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are < 2.0cm in the short axis.
  • MRI Pelvis/Prostate feasible for staging and planning
  • Patients with contraindications to MRI are not eligible
  • Patient deemed eligible for complete androgen blockade, and androgen deprivation therapy by treating physician (this includes consideration of baseline liver function prior to initiation of therapy, if necessary at physician's discretion). For patients not eligible for anti-testosterone therapy, hormone therapy with LHRH agonist alone will be permitted on case by case by study Principal Investigator. AS can be any LHRH agonists, LHRG antagonists or anti-androgens that are approved for androgen suppression for the treatment of prostate cancer.
  • Patient does not have known allergy to polyethylene glycol hydrogel (spacer material).
  • Patient deemed eligible for rectal spacer ( Space OAR) placement by treating physician.
  • Histologic confirmation of diagnosis of adenocarcinoma of the prostate will be required by biopsy.

Who cannot join

  • Eligible patients should not have had previous pelvic radiotherapy, chemotherapy or surgery for prostate cancer.
  • There must be no plans for the patient to receive other concomitant or post treatment adjuvant antineoplastic therapy while on this protocol including surgery, cryotherapy, conventionally fractionated radiotherapy, 2nd generation anti-androgen therapy (i.e Enzalutamide, Abiraterone, etc.),or chemotherapy given as part of the treatment of prostate cancer.
  • The patient should not have direct evidence of regional or distant metastases after appropriate staging studies, including no distant metastases (M0) on bone scan within 90 days of study enrollment. Equivocal bone scan findings are allowed if plain films are negative for metastasis. PET or PSMA scans can be performed instead of a bone scan.
  • Patients diagnosed with invasive malignancy are not eligible (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (e.g., oral cavity).
  • Patients diagnosed with severe, active co-morbidity, defined as follows are not eligible:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months.
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  • Transmural myocardial infarction within the last 6 months.
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration.
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
  • Patients with history of inflammatory colitis (including Crohn's Disease and Ulcerative colitis), active lupus, and scleroderma or active collagen vascular disease are not eligible.
  • Patients should not have undergone previous transurethral resection of the prostate (TURP) within 1 year.
  • Patients with history of inflammatory colitis (including Crohn's Disease and Ulcerative colitis) are not eligible.
  • There must be no plans for the patient to receive other concomitant or post treatment adjuvant antineoplastic therapy while on this protocol including surgery, cryotherapy, conventionally fractionated radiotherapy, 2nd generation anti-androgen therapy (i.e Enzalutamide, Abiraterone, etc.),or chemotherapy given as part of the treatment of prostate cancer.
  • The patient should not have direct evidence of regional or distant metastases after appropriate staging studies, including no distant metastases (M0) on bone scan within 90 days of study enrollment. Equivocal bone scan findings are allowed if plain films are negative for metastasis. PET or PSMA scans can be performed instead of a bone scan.
  • Patients diagnosed with invasive malignancy are not eligible (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (e.g., oral cavity).
  • Patients diagnosed with severe, active co-morbidity, defined as follows are not eligible:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months.
  • Transmural myocardial infarction within the last 6 months.
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration.
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
  • Patients with history of inflammatory colitis (including Crohn's Disease and Ulcerative colitis), active lupus, and scleroderma or active collagen vascular disease are not eligible.
  • Patients should not have undergone previous transurethral resection of the prostate (TURP) within 1 year.
  • Patients with history of inflammatory colitis (including Crohn's Disease and Ulcerative colitis) are not eligible.
  • Patients should not have a history of significant psychiatric illness.
  • Patients may have used prior hormonal therapy, but it should be limited to no more than 9 months of therapy prior to enrollment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75239

Other trials in United States

About this study

Official title: Phase I Clinical Trial of Stereotactic Ablative Radiotherapy (SABR) of Pelvis and Prostate Targets for Patients With High Risk Prostate Cancer

Since high risk prostate cancer requires higher radiation, this study is being done to determine the maximum tolerated dose of radiation to the prostate and pelvic regions. Also to determine the feasibility and safety of each treatment fraction by using cone-beam Computed Tomography(CT) information and high speed Graphics Processing Unit based computation treatment planning systems. We also plan to determine the safety of treatment to the prostate. Health-related quality of life will be measured as part of current clinical practice.

  • Determine the maximum tolerated dose (MTD) or to safely escalate dose to the pelvic nodal using 90 day acute toxicity endpoint
  • Determine feasibility and safety of adaptive real time re-planning of the pelvic nodal region at each treatment fraction by using cone-beam CT (CBCT) information and high speed GPU based computation treatment planning systems
  • Determine the safety and tolerability of 9.5 Gy per fraction in five fractions (47.5 Gy total dose) to the prostate
  • Determine the feasibility and safety of temporal enhanced ultrasound for prostate lesion tracking during radiation therapy
  • To follow tumor related outcomes (i.e. PSA control, progression-free survival (PFS), distant metastasis (DM) free survival, and overall survival (OS)
  • Health-related quality of life (HRQOL) will be measured as part of current clinical practice Patients in each dose cohort will all be treated as a single group for dose escalation. There will be two levels of dose escalation-to prostate lesions and to pelvic lymph node region. Prostate/SV PTV will be treated at a fixed dose of 9.5 Gy per fraction for 5 fractions (47.5 Gy) based on our previous phase I/II study experiences. The starting dose for the dose escalation to the pelvic region PTV will be 4.5 Gy per fraction for 5 fractions (total dose= 22.5 Gy). Subsequent cohorts of patients will receive an additional 0.5 Gy per treatment (total 2.5 Gy per escalation). The starting dose for MRI-visible prostatic lesions will be 10 Gy and subsequent cohorts will receive an additional 0.5Gy per treatment (total of 2.5Gy per escalation).
Read the detailed description

Patients will be accrued in alternating dose levels. The two distinct areas of dose escalations (pelvic lymph node and prostate lesion) will take place one at a time. Minimum waiting periods will be assigned between each dose cohort to observe toxicity. The phase I portion of the study will be completed when dose limiting toxicity is reached or when a sufficiently high dose level (i.e.,5.5 Gy per fraction to a total 27.5 Gy for pelvic lymph node region and 11Gy per fraction to a total of 55Gy to the prostate lesion), is attained to consider the therapy likely to be efficacious. All patients will be treated with a total of 24 months of androgen suppression therapy (ADT). Radiation therapy will start 8-12 weeks after initiation of ADT.

No. Patients for each cohort: 7-15 Cohort 1: 9.5 Gy per fraction to prostate/SV, 10 Gy per fraction to prostate lesion, 4.5Gy per fraction to pelvic lymph node region for 5 fractions for a total of 47.5 / 50 / 22.5 Gy to Prostate+SV /Prostate lesions/Nodes Cohort 2: 9.5 Gy per fraction to prostate/SV, 10 Gy per fraction to prostate lesion, 5Gy per fraction to pelvic lymph node region for 5 fractions for a total of 47.5 / 50 / 25 Gy to Prostate+SV /Prostate lesions/Nodes Cohort 3: 9.5 Gy per fraction to prostate/SV, 10.5 Gy per fraction to prostate lesion, 5Gy per fraction to pelvic lymph node region for 5 fractions for a total of 47.5 / 52.5 / 25 Gy to Prostate+SV /Prostate lesions/Nodes Cohort 4: 9.5 Gy per fraction to prostate/SV, 10.5 Gy per fraction to prostate lesion, 5.5 Gy per fraction to pelvic lymph node region for 5 fractions for a total of 47.5 / 52.5 / 27.5 Gy to Prostate+SV /Prostate lesions/Nodes Cohort 5: 9.5 Gy per fraction to prostate/SV, 11 Gy per fraction to prostate lesion, 5.5 Gy per fraction to pelvic lymph node region for 5 fractions for a total of 47.5 / 55 / 27.5 Gy to Prostate+SV /Prostate lesions/Nodes

Conditions
Prostate Cancer
Being tested
Stereotactic Ablative Radiotherapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic Ablative RadiotherapyRadiation

    Also called SABR

    SABR x5 fractions CBCT based image-guidance prior to each fraction: localize based on prostate/seeds positions SCORE system

Study groups in NCT02353819
Study groupRoleWhat they receive
Stereotactic Ablative RadiotherapyExperimentalStereotactic Ablative Radiotherapy (SABR)
Receives: Radiation: Stereotactic Ablative Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. maximum tolerated dose (MTD)

    Determine the maximum tolerated dose (MTD) or to safely escalate dose to the pelvic nodal PTV using 90 day acute toxicity endpoint

    Measured: 90 days

Secondary outcomes (5)

  1. Adverse events

    Determine the safety of 9.5 Gy per fraction in five fractions (47.5 Gy total dose) to the prostate/SV PTV

    Measured: 90 days

  2. PSA

    To follow tumor response to treatment

    Measured: 5 years

  3. Progression-free survival

    To follow tumor related outcomes (progression-free survival (PFS), distant metastasis (DM) free survival)

    Measured: 5 years

  4. Overall survival

    To follow tumor related outcomes , overall survival (OS)

    Measured: 5 years

  5. Health-related quality of life

    Health-related quality of life (HRQOL) will be measured as part of current clinical practice

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionJan 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02353819
Sponsor's protocol ID
STU 062014-027
Other IDs
1R01EB027898-01
Status last verified
Feb 2026
First submitted
16 Jan 2015
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Stereotactic Ablative Radiotherapy 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 19 inclusion and 29 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: under way, not looking for participants, as of the sponsor's last update on 23 Feb 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

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?

maximum tolerated dose (MTD) (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02353819.

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 23 Feb 2026.

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