Prostate AdenocarcinomaPhase 2EXCALIBURNCT04915508
Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer With Rising PSA After Radical Prostatectomy
A Phase 2 study testing Hormone Therapy and Stereotactic Body Radiation Therapy in people with Prostate Adenocarcinoma and Stage IIIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This phase II trial investigates the effect of extremely hypofractionated intensity modulated stereotactic body radiotherapy in treating patients with prostate cancer that has rising prostate specific antigen (PSA) after radical prostatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma, Stage IIIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8, Stage IIIC Prostate Cancer AJCC v8
- What is being tested?
- Hormone Therapy and Stereotactic Body Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2021to 31 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
- History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent
- Presence of any ONE of the following:
- Adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, OR presence of tertiary Gleason grade 5 disease)
- Documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng/mL
- Intermediate- or high-risk Decipher genomic classifier score
- Identification of prostate cancer in >= 1 lymph node at the time of prostatectomy (pN+ disease)
Show all 11Show fewer
- CT scan and MRI of the pelvis within 120 days prior to enrollment [note: (a) if patient has medical contraindication to MRI, an exemption will be granted and enrollment can proceed; (b) for patients with PSA < 1.0 ng/mL, the treatment planning CT can substitute for a diagnostic CT scan; (c) a low-field, radiation planning MRI can replace the diagnostic MRI if the patient refuses or cannot obtain a high-field MRI]
- Bone scan OR advanced nuclear imaging study within 120 days prior to enrollment for patients with PSA > 1.0 ng/mL
- Age >= 18
- Karnofsky performance status (KPS) >= 70 and/or Eastern Cooperative Oncology Group (ECOG) =< 2
- Ability to understand, and willingness to sign, the written informed consent
Who cannot join
- Patients with any evidence of distant metastases. Note, evidence of lymphadenopathy below the level of the renal arteries can be deemed loco regional per the discretion of the investigator
- Patients with neuroendocrine or small cell carcinoma of the prostate
- Prior pelvic radiotherapy
- History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for Adjuvant or Salvage Treatment for Rising PSA After Radical Prostatectomy (EXCALIBUR)
This phase II trial investigates the effect of extremely hypofractionated intensity modulated stereotactic body radiotherapy in treating patients with prostate cancer that has rising prostate specific antigen (PSA) after radical prostatectomy. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the two-year change in patient-reported gastrointestinal (GI) symptoms based on the Expanded Prostate Cancer Index (EPIC) instrument following stereotactic body radiotherapy (SBRT) to the prostate bed and/or pelvic lymph nodes, with a comparison to historical control data for more prolonged radiation regimens.
II. To determine the two-year change in patient-reported urinary (GU) symptoms based on the EPIC instrument following stereotactic body radiotherapy (SBRT) to the prostate bed and/or pelvic lymph nodes, with a comparison to historical control data for more prolonged radiation regimens.
SECONDARY OBJECTIVES:
- To quantify patient-reported GI symptoms using the EPIC instrument at 3 months, 6 months, 1 and 5 years.
II. To quantify patient-reported GU symptoms using the EPIC instrument at 3 months, 6 months, 1 and 5 years.
III. To quantify rates and severity of acute physician scored adverse events using the Common Terminology Criteria for Adverse Events (CTCAE version [v.] 5.0) scale.
IV. To quantify the five-year cumulative incidence of physician scored adverse events the CTCAE v4.03 scale.
- To quantify five-year progression-free survival. VI. To quantify 5-year cumulative incidence of biochemical recurrence. VII. To quantify 5-year distant metastasis-free survival.
EXPLORATORY OBJECTIVES:
- To compare all primary and secondary endpoints between patients treated with an magnetic resonance imaging (MRI)-guided versus a computed tomography (CT)-guided linear accelerator.
II. To compare primary and secondary endpoints between patients treated with short course (=< 6 months) or long-term >= 12 months) antiandrogen therapy (ADT).
OUTLINE:
Patients undergo SBRT every other day or on consecutive days for up to 14 days. Patients may receive hormonal therapy at the discretion of the treating physician.
After completion of study treatment, patients are followed up every 3 months for the first year, and then every 6 months for up to 5 years.
- Conditions
- Prostate Adenocarcinoma, Stage IIIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8, Stage IIIC Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
- Being tested
- Hormone Therapy, Stereotactic Body Radiation Therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormone TherapyDrug
Also called Chemotherapy-Hormones/Steroids, Endocrine Therapy, Hormonal Therapy, hormone treatment
Receive hormonal therapy
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo SBRT
| Study group | Role | What they receive |
|---|---|---|
| Treatment (SBRT, hormone therapy) | Experimental | Patients undergo SBRT every other day or on consecutive days for up to 14 days. Patients may receive hormonal therapy at the discretion of the treating physician. Receives: Drug: Hormone Therapy; Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Expanded Prostate Cancer Index (EPIC) score for the gastrointestinal domain
EPIC assessed the disease-specific aspects of prostate cancer and its therapies within the gastrointestinal summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.
Measured: Baseline up to 2 years
Change of Expanded Prostate Cancer Index (EPIC) score for the genitourinary domain
EPIC assessed the disease-specific aspects of prostate cancer and its therapies within the genitourinary summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.
Measured: Baseline up to 2 years
Secondary outcomes (7)
Patient-reported gastrointestinal (GI) symptoms
EPIC assessed the disease-specific aspects of prostate cancer and its therapies within the gastrointestinal summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.
Measured: At 3 months, 6 months, 1year, and 5 years
Patient-reported genitourinary (GU) symptoms
EPIC assessed the disease-specific aspects of prostate cancer and its therapies within the genitourinary summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.
Measured: At 3 months, 6 months, 1year, and 5 years
Incidence of acute physician scored adverse events
Will be assessed by using the Common Terminology Criteria for Adverse Events version 4.0.
Measured: Up to 5 years
Cumulative incidence of physician scored adverse events
Will be assessed by using the Common Terminology Criteria for Adverse Events version 4.0.
Measured: Up to 5 years
Progression-free survival
Measured: Up to 5 years
Cumulative incidence of biochemical recurrence
Measured: Up to 5 years
Distant metastasis-free survival
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start23 Jun 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer 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
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amar Kishan, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915508
- Sponsor's protocol ID
- 21-000263
- Other IDs
- NCI-2021-05447
- Acronym
- EXCALIBUR
- Status last verified
- Jul 2026
- First submitted
- 1 Jun 2021
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for Adjuvant or Salvage Treatment for Rising PSA After Radical Prostatectomy (EXCALIBUR)
- ClinicalTrials.gov ID
- NCT04915508
- Acronym / sponsor ID
- EXCALIBUR / 21-000263
- Conditions
- Prostate Adenocarcinoma, Stage IIIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8, Stage IIIC Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Jun 2021 (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 trial investigates the effect of extremely hypofractionated intensity modulated stereotactic body radiotherapy in treating patients with prostate cancer that has rising prostate specific antigen (PSA) after radical prostatectomy. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
Detailed description
PRIMARY OBJECTIVES:
- To determine the two-year change in patient-reported gastrointestinal (GI) symptoms based on the Expanded Prostate Cancer Index (EPIC) instrument following stereotactic body radiotherapy (SBRT) to the prostate bed and/or pelvic lymph nodes, with a comparison to historical control data for more prolonged radiation regimens.
II. To determine the two-year change in patient-reported urinary (GU) symptoms based on the EPIC instrument following stereotactic body radiotherapy (SBRT) to the prostate bed and/or pelvic lymph nodes, with a comparison to historical control data for more prolonged radiation regimens.
SECONDARY OBJECTIVES:
- To quantify patient-reported GI symptoms using the EPIC instrument at 3 months, 6 months, 1 and 5 years.
II. To quantify patient-reported GU symptoms using the EPIC instrument at 3 months, 6 months, 1 and 5 years.
III. To quantify rates and severity of acute physician scored adverse events using the Common Terminology Criteria for Adverse Events (CTCAE version [v.] 5.0) scale.
IV. To quantify the five-year cumulative incidence of physician scored adverse events the CTCAE v4.03 scale.
- To quantify five-year progression-free survival. VI. To quantify 5-year cumulative incidence of biochemical recurrence. VII. To quantify 5-year distant metastasis-free survival.
EXPLORATORY OBJECTIVES:
- To compare all primary and secondary endpoints between patients treated with an magnetic resonance imaging (MRI)-guided versus a computed tomography (CT)-guided linear accelerator.
II. To compare primary and secondary endpoints between patients treated with short course (=< 6 months) or long-term >= 12 months) antiandrogen therapy (ADT).
OUTLINE:
Patients undergo SBRT every other day or on consecutive days for up to 14 days. Patients may receive hormonal therapy at the discretion of the treating physician.
After completion of study treatment, patients are followed up every 3 months for the first year, and then every 6 months for up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (SBRT, hormone therapy) | Experimental | Drug: Hormone Therapy, Radiation: Stereotactic Body Radiation TherapyPatients undergo SBRT every other day or on consecutive days for up to 14 days. Patients may receive hormonal therapy at the discretion of the treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent
- Presence of any ONE of the following:
- CT scan and MRI of the pelvis within 120 days prior to enrollment [note: (a) if patient has medical contraindication to MRI, an exemption will be granted and enrollment can proceed; (b) for patients with PSA < 1.0 ng/mL, the treatment planning CT can substitute for a diagnostic CT scan; (c) a low-field, radiation planning MRI can replace the diagnostic MRI if the patient refuses or cannot obtain a high-field MRI]
- Bone scan OR advanced nuclear imaging study within 120 days prior to enrollment for patients with PSA > 1.0 ng/mL
- Age >= 18
Key exclusion criteria (4 listed)
- Patients with any evidence of distant metastases. Note, evidence of lymphadenopathy below the level of the renal arteries can be deemed loco regional per the discretion of the investigator
- Patients with neuroendocrine or small cell carcinoma of the prostate
- Prior pelvic radiotherapy
- History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
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 |
|---|---|---|
| Hormone TherapyAlso: Chemotherapy-Hormones/Steroids, Endocrine Therapy, Hormonal Therapy, hormone treatmentReceive hormonal therapy | Drug | Treatment (SBRT, hormone therapy) |
| Stereotactic Body Radiation TherapyAlso: SABR, SBRT, Stereotactic Ablative Body Radiation TherapyUndergo SBRT | Radiation | Treatment (SBRT, hormone therapy) |
Primary outcome
Change of Expanded Prostate Cancer Index (EPIC) score for the gastrointestinal domain
Time frame: Baseline up to 2 years
EPIC assessed the disease-specific aspects of prostate cancer and its therapies within the gastrointestinal summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.
Change of Expanded Prostate Cancer Index (EPIC) score for the genitourinary domain
Time frame: Baseline up to 2 years
EPIC assessed the disease-specific aspects of prostate cancer and its therapies within the genitourinary summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.
7 secondary outcomes
Patient-reported gastrointestinal (GI) symptoms
Time frame: At 3 months, 6 months, 1year, and 5 years
Patient-reported genitourinary (GU) symptoms
Time frame: At 3 months, 6 months, 1year, and 5 years
Incidence of acute physician scored adverse events
Time frame: Up to 5 years
Cumulative incidence of physician scored adverse events
Time frame: Up to 5 years
Progression-free survival
Time frame: Up to 5 years
Cumulative incidence of biochemical recurrence
Time frame: Up to 5 years
Distant metastasis-free survival
Time frame: Up to 5 years
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 17 Jul 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. This study is not recruiting at the moment.
Amar Kishan principal investigator
UCLA / Jonsson Comprehensive Cancer 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 Hormone Therapy and Stereotactic Body Radiation Therapy in people with Prostate Adenocarcinoma and Stage IIIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8, run by Jonsson Comprehensive 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 11 inclusion and 4 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 17 Jul 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?
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?
Change of Expanded Prostate Cancer Index (EPIC) score for the gastrointestinal domain (time frame: Baseline up to 2 years). 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 17 Jul 2026.