Prostate CancerPhase 2NCT04422132

Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 Weeks

A Phase 2 study testing 5 days Radiation Therapy (32.5 Gy in 5 fractions) and 20 days Radiation therapy (55 Gy in 20 fractions) in people with Prostate Cancer, run by Weill Medical College of Cornell University 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

The purpose of this study is to compare urinary and bowel side effects of hypofractionated radiotherapy in 20 treatments (4 weeks) to ultra-hypofractionated radiotherapy in 5 treatments (2 weeks) for prostate cancer that has returned after prostatectomy. Read more about this study

Who is it for?: Ages 18 to 90 years, men only
Conditions the study is for: Prostate Cancer
What is being tested?: 5 days Radiation Therapy (32.5 Gy in 5 fractions) and 20 days Radiation therapy (55 Gy in 20 fractions)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 137 participants
Where: 1 siteUnited States
Study dates: 24 Sep 2020to 31 Dec 2033
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 90 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Men aged 18 and older with histologically confirmed prostate cancer after prostatectomy with detectable PSA. PSA does not need to be detectable for men with pathologically node positive disease.
KPS >=70
Patient with no evidence of distant metastatic disease on PET/CT/MRI or bone scan < 9 months prior to enrollment. Patients with positive pelvic lymph nodes are eligible.
Ability to receive MRI-guided radiotherapy.
Equivocal evidence of metastatic disease outside the pelvis on standard imaging requires documented negative biopsy.
Ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire.

Who cannot join

Prior history of receiving pelvic radiotherapy.
Patient with inflammatory bowel disease.
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of ultra-hypofractionated radiotherapy.
History of bladder neck or urethral stricture.

Trial locations and contacts

1 site in 1 country.

United States1 site

Weill Cornell Medicine
New York, New York, 10065

Other trials in United States

About this study

Read the detailed description

The standard treatment for most patients with biochemical recurrence after radical prostatectomy is salvage radiotherapy. Salvage radiotherapy delays the need for chronic, non-curative treatment, such as long-term androgen suppression, and is the only potentially curative treatment of some biochemical recurrences after prostatectomy.

Patients are recommended to undergo salvage radiotherapy to eradicate biochemical disease delivered in approximately 40 treatments over the course of 8 weeks, representing a high burden of therapy, which may be related to lower utilization of salvage radiotherapy. Modern radiotherapy for prostate cancer has been afforded many advantages including advanced image-guided radiotherapy allowing for larger dose delivery in fewer treatments and smaller margins with hypofractionated (20 treatments) and ultra-hypofractionated (5 treatments) radiotherapy.

In patients that need salvage radiotherapy, the potential advantages of hypofractionated and ultra-hypofractionated radiotherapy delivered over 20 or 5 treatments are: 1) increased convenience to patients because of fewer treatment days, 2) reduced costs to patients because of reduced travel expenses and copays, 3) improved resource utilization for physicians because of the fewer number of treatments per patient and consequently 4) reduced cost to society. In prostate cancer specifically, hypofractionated and ultra-hypofractionated radiotherapy has the added potential of not increasing toxicity with shorter treatment times.

Conditions: Prostate Cancer
Being tested: 5 days Radiation Therapy (32.5 Gy in 5 fractions), 20 days Radiation therapy (55 Gy in 20 fractions)
Medical subject headings: Prostatic Neoplasms

What participants receive

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

5 days Radiation Therapy (32.5 Gy in 5 fractions)Radiation
Patients will receive treatment to the prostate fossa +/- nodes in either 32.5 Gy in 5 fractions or 55 Gy in 20 fractions.
20 days Radiation therapy (55 Gy in 20 fractions)Radiation
Patients will receive treatment to the prostate fossa +/- nodes in either 32.5 Gy in 5 fractions or 55 Gy in 20 fractions.

Study groups in NCT04422132
Study group	Role	What they receive
ARM 1 - 2 weeks	Active comparator	Patients will receive treatment to the prostate fossa +/- nodes in 32.5 Gy in 5 fractions. Patients receiving 32.5 Gy in 5 fractions cannot be treated on consecutive days. Receives: Radiation: 5 days Radiation Therapy (32.5 Gy in 5 fractions)
ARM 2 - 4 weeks	Active comparator	Patients will receive treatment to the prostate fossa +/- nodes in 55 Gy in 20 fractions. Receives: Radiation: 20 days Radiation therapy (55 Gy in 20 fractions)

What is being measured

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

Change in the Number of Patient-reported GI Symptoms Using the Expanded Prostate Cancer Index Composite (EPIC)
The primary objective is to demonstrate that 5 days of ultra-hypofractionated radiotherapy does not significantly increase patient-reported Gastrointestinal (GI) and Genitourinary (GU) symptoms over 20 days of hypofractionated radiotherapy 2 years after treatment completion as measured by EPIC.
Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.
Measured: Baseline
Change in the Number of Patient-reported GI Symptoms Using the Expanded Prostate Cancer Index Composite (EPIC)
The primary objective is to demonstrate that 5 days of ultra-hypofractionated radiotherapy does not significantly increase patient-reported Gastrointestinal (GI) and Genitourinary (GU) symptoms over 20 days of hypofractionated radiotherapy 2 years after treatment completion as measured by EPIC.
Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.
Measured: 24 months
Change in the Number of Patient-reported GU Symptoms Using the Expanded Prostate Cancer Index Composite (EPIC)
The primary objective is to demonstrate that 5 days of ultra-hypofractionated radiotherapy does not significantly increase patient-reported Gastrointestinal (GI) and Genitourinary (GU) symptoms over 20 days of hypofractionated radiotherapy 2 years after treatment completion as measured by EPIC.
Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.
Measured: Baseline
Change in the Number of Patient-reported GU Symptoms Using the Expanded Prostate Cancer Index Composite (EPIC)
The primary objective is to demonstrate that 5 days of ultra-hypofractionated radiotherapy does not significantly increase patient-reported Gastrointestinal (GI) and Genitourinary (GU) symptoms over 20 days of hypofractionated radiotherapy 2 years after treatment completion as measured by EPIC.
Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.
Measured: 24 months

Secondary outcomes (21)

Change in the Number of Patient Reported GI Symptoms at Specific Intervals as Measured by Expanded Prostate Cancer Index Composite (EPIC)
Secondary endpoints will include both the safety endpoints including change in GI and GU symptoms at 3, 6, 12, 24 and 60 months from end of treatment as measured by EPIC.
Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.
Adverse events can be unexpected or expected, related to treatment.
Measured: 3 months
Change in the Number of Patient Reported GI Symptoms at Specific Intervals as Measured by Expanded Prostate Cancer Index Composite (EPIC)
Secondary endpoints will include both the safety endpoints including change in GI and GU symptoms at 3, 6, 12, 24 and 60 months from end of treatment as measured by EPIC.
Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.
Adverse events can be unexpected or expected, related to treatment.
Measured: 6 months
Change in the Number of Patient Reported GI Symptoms at Specific Intervals as Measured by Expanded Prostate Cancer Index Composite (EPIC)
Secondary endpoints will include both the safety endpoints including change in GI and GU symptoms at 3, 6, 12, 24 and 60 months from end of treatment as measured by EPIC.
Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.
Adverse events can be unexpected or expected, related to treatment.
Measured: 12 months
Change in the Number of Patient Reported GI Symptoms at Specific Intervals as Measured by Expanded Prostate Cancer Index Composite (EPIC)
Secondary endpoints will include both the safety endpoints including change in GI and GU symptoms at 3, 6, 12, 24 and 60 months from end of treatment as measured by EPIC.
Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.
Adverse events can be unexpected or expected, related to treatment.
Measured: 24 months
Change in the Number of Patient Reported GI Symptoms at Specific Intervals as Measured by Expanded Prostate Cancer Index Composite (EPIC)
Secondary endpoints will include both the safety endpoints including change in GI and GU symptoms at 3, 6, 12, 24 and 60 months from end of treatment as measured by EPIC.
Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.
Adverse events can be unexpected or expected, related to treatment.
Measured: 60 months
Change in the Number of Patient Reported GU Symptoms at Specific Intervals as Measured by Expanded Prostate Cancer Index Composite (EPIC)
Secondary endpoints will include both the safety endpoints including change in GI and GU symptoms at 3, 6, 12, 24 and 60 months from end of treatment as measured by EPIC.
Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.
Adverse events can be unexpected or expected, related to treatment.
Measured: 3 months
Change in the Number of Patient Reported GU Symptoms at Specific Intervals as Measured by Expanded Prostate Cancer Index Composite (EPIC)
Secondary endpoints will include both the safety endpoints including change in GI and GU symptoms at 3, 6, 12, 24 and 60 months from end of treatment as measured by EPIC.
Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.
Adverse events can be unexpected or expected, related to treatment.
Measured: 6 months
Change in the Number of Patient Reported GU Symptoms at Specific Intervals as Measured by Expanded Prostate Cancer Index Composite (EPIC)
Secondary endpoints will include both the safety endpoints including change in GI and GU symptoms at 3, 6, 12, 24 and 60 months from end of treatment as measured by EPIC.
Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.
Adverse events can be unexpected or expected, related to treatment.
Measured: 12 months
Change in the Number of Patient Reported GU Symptoms at Specific Intervals as Measured by Expanded Prostate Cancer Index Composite (EPIC)
Secondary endpoints will include both the safety endpoints including change in GI and GU symptoms at 3, 6, 12, 24 and 60 months from end of treatment as measured by EPIC.
Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.
Adverse events can be unexpected or expected, related to treatment.
Measured: 24 months
Change in the Number of Patient Reported GU Symptoms at Specific Intervals as Measured by Expanded Prostate Cancer Index Composite (EPIC)
Secondary endpoints will include both the safety endpoints including change in GI and GU symptoms at 3, 6, 12, 24 and 60 months from end of treatment as measured by EPIC.
Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.
Adverse events can be unexpected or expected, related to treatment.
Measured: 60 months
Progression Free Survival (PFS) at 3 Months
Progression Free Survival (PFS) where progression is defined as the first occurrence of biochemical failure (BF), local failure, regional failure, distant metastasis (DM), institution of new unplanned anticancer treatment, or death from prostate cancer (PCSM).
Measured: 3 months
Progression Free Survival (PFS) at 6 Months
Compare Progression Free Survival (PFS) where progression is defined as the first occurrence of biochemical failure (BF), local failure, regional failure, distant metastasis (DM), institution of new unplanned anticancer treatment, or death from prostate cancer (PCSM).
Measured: 6 months
Progression Free Survival (PFS) at 12 Months
Compare Progression Free Survival (PFS) where progression is defined as the first occurrence of biochemical failure (BF), local failure, regional failure, distant metastasis (DM), institution of new unplanned anticancer treatment, or death from prostate cancer (PCSM).
Measured: 12 months
Progression Free Survival (PFS) at 24 Months
Compare Progression Free Survival (PFS) where progression is defined as the first occurrence of biochemical failure (BF), local failure, regional failure, distant metastasis (DM), institution of new unplanned anticancer treatment, or death from prostate cancer (PCSM).
Measured: 24 months
Progression Free Survival (PFS) at 60 Months
Compare Progression Free Survival (PFS) where progression is defined as the first occurrence of biochemical failure (BF), local failure, regional failure, distant metastasis (DM), institution of new unplanned anticancer treatment, or death from prostate cancer (PCSM).
Measured: 60 months
Overall Survival (OS) at 3 Months
Overall survival (OS) will be measured among the participants
Measured: 3 months
Overall Survival (OS) at 6 Months
Overall survival (OS) will be measured among the participants
Measured: 6 months
Overall Survival (OS) at 12 Months
Overall survival (OS) will be measured among the participants
Measured: 12 months
Overall Survival (OS) at 24 Months
Overall survival (OS) will be measured among the participants
Measured: 24 months
Overall Survival (OS) at 60 Months
Overall survival (OS) will be measured among the participants
Measured: 60 months
Number of Patients Who Expired Due to Prostate Cancer.
Measured: Through study completion, an average of 10 years

Timeline

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

24 Sep 202031 Dec 2033

First posted9 Jun 2020
Study start24 Sep 2020
Primary completion31 Dec 2025
Study completion31 Dec 2033 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by Weill Medical College of Cornell UniversityThe 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 137 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04422132
Sponsor's protocol ID: 20-03021572
Status last verified: Oct 2026
First submitted: 5 Jun 2020
Last updated: 14 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Marciscano AE, Wolfe S, Zhou XK, Barbieri CE, Formenti SC, Hu JC, Molina AM, Nanus DM, Nauseef JT, Scherr DS, Sternberg CN, Tagawa ST, Nagar H. Randomized phase II trial of MRI-guided salvage radiotherapy for prostate cancer in 4 weeks versus 2 weeks (SHORTER). BMC Cancer. 2023 Aug 22;23(1):781. doi: 10.1186/s12885-023-11278-3.
PubMed 37608258

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 Weeks
ClinicalTrials.gov ID: NCT04422132
Acronym / sponsor ID: 20-03021572
Conditions: Prostate Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 137 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: Viewray Inc.
Study start: 24 Sep 2020 (actual)
Primary completion: 31 Dec 2025 (actual)
Study completion: 31 Dec 2033 (estimated)
First posted: 9 Jun 2020 (actual)
Results: Posted 14 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ARM 1 - 2 weeks	Active comparator	Radiation: 5 days Radiation Therapy (32.5 Gy in 5 fractions)Patients will receive treatment to the prostate fossa +/- nodes in 32.5 Gy in 5 fractions. Patients receiving 32.5 Gy in 5 fractions cannot be treated on consecutive days.
ARM 2 - 4 weeks	Active comparator	Radiation: 20 days Radiation therapy (55 Gy in 20 fractions)Patients will receive treatment to the prostate fossa +/- nodes in 55 Gy in 20 fractions.

Who may qualify

Ages: 18 to 90 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Men aged 18 and older with histologically confirmed prostate cancer after prostatectomy with detectable PSA. PSA does not need to be detectable for men with pathologically node positive disease.
KPS >=70
Patient with no evidence of distant metastatic disease on PET/CT/MRI or bone scan < 9 months prior to enrollment. Patients with positive pelvic lymph nodes are eligible.
Ability to receive MRI-guided radiotherapy.
Equivocal evidence of metastatic disease outside the pelvis on standard imaging requires documented negative biopsy.

Key exclusion criteria (4 listed)

Prior history of receiving pelvic radiotherapy.
Patient with inflammatory bowel disease.
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of ultra-hypofractionated radiotherapy.
History of bladder neck or urethral stricture.

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
5 days Radiation Therapy (32.5 Gy in 5 fractions)Patients will receive treatment to the prostate fossa +/- nodes in either 32.5 Gy in 5 fractions or 55 Gy in 20 fractions.	Radiation	ARM 1 - 2 weeks
20 days Radiation therapy (55 Gy in 20 fractions)Patients will receive treatment to the prostate fossa +/- nodes in either 32.5 Gy in 5 fractions or 55 Gy in 20 fractions.	Radiation	ARM 2 - 4 weeks

Primary outcome

Change in the Number of Patient-reported GI Symptoms Using the Expanded Prostate Cancer Index Composite (EPIC)
Time frame: Baseline
The primary objective is to demonstrate that 5 days of ultra-hypofractionated radiotherapy does not significantly increase patient-reported Gastrointestinal (GI) and Genitourinary (GU) symptoms over 20 days of hypofractionated radiotherapy 2 years after treatment completion as measured by EPIC. Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.
Change in the Number of Patient-reported GI Symptoms Using the Expanded Prostate Cancer Index Composite (EPIC)
Time frame: 24 months
The primary objective is to demonstrate that 5 days of ultra-hypofractionated radiotherapy does not significantly increase patient-reported Gastrointestinal (GI) and Genitourinary (GU) symptoms over 20 days of hypofractionated radiotherapy 2 years after treatment completion as measured by EPIC. Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.
Change in the Number of Patient-reported GU Symptoms Using the Expanded Prostate Cancer Index Composite (EPIC)
Time frame: Baseline
The primary objective is to demonstrate that 5 days of ultra-hypofractionated radiotherapy does not significantly increase patient-reported Gastrointestinal (GI) and Genitourinary (GU) symptoms over 20 days of hypofractionated radiotherapy 2 years after treatment completion as measured by EPIC. Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.
Change in the Number of Patient-reported GU Symptoms Using the Expanded Prostate Cancer Index Composite (EPIC)
Time frame: 24 months
The primary objective is to demonstrate that 5 days of ultra-hypofractionated radiotherapy does not significantly increase patient-reported Gastrointestinal (GI) and Genitourinary (GU) symptoms over 20 days of hypofractionated radiotherapy 2 years after treatment completion as measured by EPIC. Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes.

21 secondary outcomes

Change in the Number of Patient Reported GI Symptoms at Specific Intervals as Measured by Expanded Prostate Cancer Index Composite (EPIC)
Time frame: 3 months
Change in the Number of Patient Reported GI Symptoms at Specific Intervals as Measured by Expanded Prostate Cancer Index Composite (EPIC)
Time frame: 6 months
Change in the Number of Patient Reported GI Symptoms at Specific Intervals as Measured by Expanded Prostate Cancer Index Composite (EPIC)
Time frame: 12 months
Change in the Number of Patient Reported GI Symptoms at Specific Intervals as Measured by Expanded Prostate Cancer Index Composite (EPIC)
Time frame: 24 months
Change in the Number of Patient Reported GI Symptoms at Specific Intervals as Measured by Expanded Prostate Cancer Index Composite (EPIC)
Time frame: 60 months
Change in the Number of Patient Reported GU Symptoms at Specific Intervals as Measured by Expanded Prostate Cancer Index Composite (EPIC)
Time frame: 3 months
Change in the Number of Patient Reported GU Symptoms at Specific Intervals as Measured by Expanded Prostate Cancer Index Composite (EPIC)
Time frame: 6 months
Change in the Number of Patient Reported GU Symptoms at Specific Intervals as Measured by Expanded Prostate Cancer Index Composite (EPIC)
Time frame: 12 months
Change in the Number of Patient Reported GU Symptoms at Specific Intervals as Measured by Expanded Prostate Cancer Index Composite (EPIC)
Time frame: 24 months
Change in the Number of Patient Reported GU Symptoms at Specific Intervals as Measured by Expanded Prostate Cancer Index Composite (EPIC)
Time frame: 60 months
Progression Free Survival (PFS) at 3 Months
Time frame: 3 months
Progression Free Survival (PFS) at 6 Months
Time frame: 6 months
Progression Free Survival (PFS) at 12 Months
Time frame: 12 months
Progression Free Survival (PFS) at 24 Months
Time frame: 24 months
Progression Free Survival (PFS) at 60 Months
Time frame: 60 months
Overall Survival (OS) at 3 Months
Time frame: 3 months
Overall Survival (OS) at 6 Months
Time frame: 6 months
Overall Survival (OS) at 12 Months
Time frame: 12 months
Overall Survival (OS) at 24 Months
Time frame: 24 months
Overall Survival (OS) at 60 Months
Time frame: 60 months
Number of Patients Who Expired Due to Prostate Cancer.
Time frame: Through study completion, an average of 10 years

Results and safety

Results posted to the registry on 14 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ARM 1 - 2 Weeks	68	68
ARM 2 - 4 Weeks	69	69

Primary outcome: Change in the Number of Patient-reported GI Symptoms Using the Expanded Prostate Cancer Index Composite (EPIC)

Time frame: Baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	ARM 1 - 2 Weeks n = 68	ARM 2 - 4 Weeks n = 69
Value	94.17 (8.6)	94.2 (9.28)

Primary outcome: Change in the Number of Patient-reported GI Symptoms Using the Expanded Prostate Cancer Index Composite (EPIC)

Time frame: 24 months. Mean (Standard Deviation). Unit: score on a scale

Measure	ARM 1 - 2 Weeks n = 50	ARM 2 - 4 Weeks n = 47
Value	92.84 (9.97)	94.35 (6.77)

Population analysed: Data in the table is representative of those participants who completed the assessment

Primary outcome: Change in the Number of Patient-reported GU Symptoms Using the Expanded Prostate Cancer Index Composite (EPIC)

Time frame: Baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	ARM 1 - 2 Weeks n = 68	ARM 2 - 4 Weeks n = 69
Value	85.62 (12.93)	85.39 (12.89)

Primary outcome: Change in the Number of Patient-reported GU Symptoms Using the Expanded Prostate Cancer Index Composite (EPIC)

Time frame: 24 months. Mean (Standard Deviation). Unit: score on a scale

Measure	ARM 1 - 2 Weeks n = 50	ARM 2 - 4 Weeks n = 47
Value	78.82 (15.79)	81.16 (15.16)

Population analysed: Data in the table is representative of those participants who completed the assessment

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events are assessed within 2 years after radiotherapy.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ARM 1 - 2 Weeks	3 of 68 (4.4%)	52 of 68 (76.5%)	2 of 68
ARM 2 - 4 Weeks	2 of 69 (2.9%)	50 of 69 (72.5%)	1 of 69

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37608258Marciscano AE, Wolfe S, Zhou XK, Barbieri CE, Formenti SC, Hu JC, Molina AM, Nanus DM, Nauseef JT, Scherr DS, Sternberg CN, Tagawa ST, Nagar H. Randomized phase II trial of MRI-guided salvage radiotherapy for prostate cancer in 4 weeks versus 2 weeks (SHORTER). BMC Cancer. 2023 Aug 22;23(1):781. doi: 10.1186/s12885-023-11278-3.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Emily Weg, M.D. principal investigator

Weill Medical College of Cornell University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 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 14 Oct 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?

Yes. Results are posted in the registry (first posted 14 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 in the Number of Patient-reported GI Symptoms Using the Expanded Prostate Cancer Index Composite (EPIC) (time frame: Baseline). The study lists 4 primary outcomes in all. 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 NCT04422132, which also lists 1 linked publication.

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 14 Oct 2026.