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Stage I Prostate Cancer AJCC v8Phase 3NCT03987386

Conventional or Hypofractionated Radiation Therapy in Treating Patients With Prostate Cancer

A Phase 3 study testing Hypofractionated Radiation Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Stage I Prostate Cancer AJCC v8 and Stage II Prostate Cancer AJCC v8, run by M.D. Anderson Cancer Center at 3 sites 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

This phase III trial studies how well hypofractionated radiation therapy works compared to the conventional one in treating patients with prostate cancer. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Hypofractionated Radiation Therapy, Quality-of-Life Assessment and Questionnaire Administration
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
3 sitesUnited States
Study dates
30 May 2019to 1 Nov 2027
Phase
Phase 3
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 age 18 or older
  • Patient has diagnosis of pathologically confirmed prostate cancer, treated with radical prostatectomy. Any type of radical prostatectomy will be permitted, including retropubic, perineal, laparoscopic, or robotically assisted
  • Patient has pathologic T2-T3M0 stage. Patients can have 5 or less metastatic pelvic lymph nodes confirmed by pathology
  • For patients radiated in the post-operative salvage setting: pathology can demonstrate any of the following features but not required, positive margin, extracapsular extension, or seminal vesicle involvement with detectable prostate-specific antigen (PSA) of >= 0.1. PSA >= 0.1 after radical prostatectomy: most recent PSA value within 12 months of registration and prior to initiating any androgen deprivation therapy (ADT)
  • Patient diagnosed with Gleason score of 6-10
  • Eastern Cooperative Oncology Group (ECOG) performance 0-2
  • Patients may receive 6 months and up to 24 months of androgen deprivation therapy. Patients may have received androgen deprivation therapy up to 12 months prior to postoperative radiotherapy
  • If the patient has a prior history of any cancer other than prostate cancer, he must have completed treatment within 1 year of study registration and the patient must have no evidence of disease of this prior non-prostate cancer

Who cannot join

  • Prior radiation therapy to prostate/seminal vesicle fossa or postoperative region
  • Neoadjuvant chemotherapy before or after prostatectomy
  • History of lupus, scleroderma, or calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia (CREST) syndrome
  • History of severe active co-morbidity or uncontrolled diabetes
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  • Transmural myocardial infarction within the last 6 months
  • Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease
  • End-stage renal disease (i.e., on dialysis or dialysis has been recommended)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • MD Anderson League City

    League City, Texas, 77573

  • MD Anderson in Sugar Land

    Sugar Land, Texas, 77478

Other trials in United States

About this study

Official title: Post Operative External Beam Radiotherapy for Prostate Cancer: Randomized Trial Comparing Standard vs. Hypofractionated Radiation Therapy (PORT-HYFX)

This phase III trial studies how well hypofractionated radiation therapy works compared to the conventional one in treating patients with prostate cancer. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. 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 OBJECTIVE:

  1. To assess the gastrointestinal (GI) and genitourinary (GU) toxicities in patients treated with hypo-fractionated postoperative radiotherapy relative to the conventional postoperative radiotherapy.

SECONDARY OBJECTIVES:

  1. To report patient outcome to include local control, loco-regional control, distant metastases, biochemical progression-free survival, prostate-cancer specific survival (PCSS), time to salvage therapy.

Ia. To compare freedom from biochemical failure (FFBF) and time to progression (TTP) with definition of post prostatectomy nadir + 2 ng/mL in both treatment arms.

II. To evaluate patient reported quality of life outcomes with hypo-fractionated compared to standard fractionated postoperative radiotherapy using validated surveys (Expanded Prostate Cancer Index Composite [EPIC]-26, Short Form [SF]-12, EuroQol 5 dimensional [EQ-5D]) and use of erectile dysfunction medications/devices.

III. To compare patient reported GU symptoms using the Common Terminology Criteria for Adverse Events (CTCAE) version 5 (specifically GU symptoms) and quality of life reports with EPIC-26, SF-12, EQ-5D survey at end of radiation therapy (RT), 6, 12, 24 and up to 60 months from the end of radiation therapy.

IV. To compare patient reported GI symptoms using CTCAE version 5 (specifically GI symptoms) and quality of life reports with the EPIC-26 SF-12, EQ-5D survey at end of RT, 6, 12, 24, and up to 60 months from the end of radiation therapy.

  1. To report health economics with cost and time based driven activity (TDABC) in delivering shorter hypofractionated courses of radiotherapy compared to standard course (indirect and direct cost).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo conventional radiation therapy daily over 7 weeks after standard of care surgery.

ARM II: Patients undergo hypofractionated radiation therapy over 4.5 weeks after standard of care surgery.

After completion of study treatment, patients are followed up at 3-6 months, and then every 6-12 months for up to 5 years.

Being tested
Hypofractionated Radiation Therapy, Quality-of-Life Assessment, Questionnaire Administration, 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.

  • Hypofractionated Radiation TherapyRadiation

    Also called Hypofractionated, Hypofractionated Radiotherapy, hypofractionation, Radiation, Hypofractionated

    Undergo hypofractionated radiation therapy

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, ENERGY_TYPE, Irradiate, Irradiated

    Undergo conventional radiation therapy

Study groups in NCT03987386
Study groupRoleWhat they receive
Arm I (conventional radiation therapy)Active comparatorPatients undergo conventional radiation therapy daily over 7 weeks after standard of care surgery.
Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Radiation Therapy
Arm II (hypofractionated radiation therapy)ExperimentalPatients undergo hypofractionated radiation therapy over 4.5 weeks after standard of care surgery.
Receives: Radiation: Hypofractionated Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

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

  1. Incidence of >= grade 2 gastrointestinal (GI) or genitourinary (GU) toxicity

    Will be denoted as Tc and Te for conventional and hypo-fractionated arm respectively.

    Measured: At 2 years

Secondary outcomes (12)

  1. Local control

    Measured: Up to 5 years

  2. Loco-regional control

    Measured: Up to 5 years

  3. Distant metastases

    Measured: Up to 5 years

  4. Biochemical progression-free survival

    Will be analyzed using the Kaplan-Meier method. Log-rank test will be used to assess the differences in time-to-event outcomes between the two groups. Cox proportional hazards model will be fit to compare the two arms while accounting for other patient characteristics.

    Measured: Up to 5 years

  5. Prostate-cancer specific survival (PCSS)

    Will be analyzed using the Kaplan-Meier method. Log-rank test will be used to assess the differences in time-to-event outcomes between the two groups. Cox proportional hazards model will be fit to compare the two arms while accounting for other patient characteristics.

    Measured: Up to 5 years

  6. Time to salvage therapy

    Will be analyzed using the Kaplan-Meier method. Log-rank test will be used to assess the differences in time-to-event outcomes between the two groups. Cox proportional hazards model will be fit to compare the two arms while accounting for other patient characteristics.

    Measured: Up to 5 years

  7. Biochemical failure (FFBF)

    Measured: Up to 5 years

  8. Time to progression (TTP)

    Will be defined as post prostatectomy nadir + 2 ng/mL in both treatment arms. Will be analyzed using the Kaplan-Meier method. Log-rank test will be used to assess the differences in time-to-event outcomes between the two groups. Cox proportional hazards model will be fit to compare the two arms while accounting for other patient characteristics.

    Measured: Up to 5 years

  9. Patient reported quality of life outcomes

    Will evaluate patient reported quality of life outcomes with hypo-fractionated compared to standard fractionated postoperative radiotherapy using validated surveys (Expanded Prostate Cancer Index Composite [EPIC]-26, Short Form [SF]-12) and use of erectile dysfunction medications/devices. Will be summarized using descriptive statistics by treatment arm and will be compared using two sample t-test or Wilcoxon rank-sum test as appropriate.

    Measured: Up to 5 years

  10. Patient reported GU symptoms

    Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5. Will be compared to quality of life reports with EPIC-26, SF-12, EQ-5D survey. Quality of life (QOL) data will be summarized using descriptive statistics by treatment arm and will be compared using two-sample t-test or Wilcoxon rank-sum test as appropriate. The generalized estimating equations (GEE) model will be fit to assess the change of GU or GI symptoms over time as well as treatment effect.

    Measured: At end of radiation therapy (RT), 6, 12, 24 and up to 60 months from the end of RT

  11. Patient reported GI symptoms

    Will be assessed by CTCAE version 5. Will be compared to quality of life reports with EPIC-26, SF-12, EQ-5D survey. QOL data will be summarized using descriptive statistics by treatment arm and will be compared using two-sample t-test or Wilcoxon rank-sum test as appropriate. The GEE model will be fit to assess the change of GU or GI symptoms over time as well as treatment effect.

    Measured: At end of RT, 6, 12, 24, and up to 60 months from the end of RT

  12. Health economics

    Will report health economics with cost and time based driven activity (TDABC) in delivering shorter hypofractionated courses of radiotherapy compared to standard course (indirect and direct cost). Will be summarized using descriptive statistics by treatment arm and will be compared using two sample t-test or Wilcoxon rank-sum test as appropriate.

    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.

  1. First posted17 Jun 2019
  2. Study start30 May 2019
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion1 Nov 2027 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03987386
Sponsor's protocol ID
2018-0703
Other IDs
NCI-2018-03367, 2018-0703
Status last verified
May 2026
First submitted
25 Jan 2019
Last updated
20 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hypofractionated Radiation Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Stage I Prostate Cancer AJCC v8 and Stage II Prostate Cancer AJCC v8, run by M.D. Anderson Cancer Center at 3 sites 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 8 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 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Incidence of >= grade 2 gastrointestinal (GI) or genitourinary (GU) toxicity (time frame: At 2 years). 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 NCT03987386.

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 20 May 2026.

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