Skip to content
Triangle logo TriangleGet started
← Study library

NCT00304759 · CITED IN SOURCE DOCUMENTS

PROFIT - Prostate Fractionated Irradiation Trial

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2017-07-31

This trial is designed to determine whether an 8-week course of escalated dose conformal radiation can be compressed safely, and with similar efficacy into a 4-week course.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: 1. Histologic diagnosis of carcinoma of the prostate within 6 months of entry without evidence of metastatic disease to the lymph nodes, bone or lung; 2. Intermediate risk prostate cancer (that is, T1-2a, Gleason score \<6, PSA 10.1-20.0 ng/ml; T2b-c Gleason \<6, PSA ≤ 20.0 ng/ml; T1-2, Gleason 7, PSA ≤ 20.0 ng/ml). Exclusion Criteria: 1. Histologic diagnosis of carcinoma of the prostate more than six months prior to study entry; 2. Previous therapy for carcinoma of the prostate other than biopsy or transurethral resection; 3. Patients previously on more than 12 weeks of hormone therapy for treatment of their prostate cancer; 4. Any other active malignancy (untreated, progressive or recurrent), except for non-melanoma skin cancer. Any inactive malignancy diagnosed within 5 years of entry, except for non-melanoma skin cancer; 5. Treatment plan cannot meet dose constraints for the hypofractionation arm of the trial; 6. Previous pelvic radiotherapy; 7. Inflammatory bowel disease.
healthy Volunteers
false
sex
MALE
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    6000 cGy / 20 fractions in 4 weeks
    intervention Names
    1. Procedure: 6000 cGy/20 fractions in 4 weeks
    label
    1
    type
    EXPERIMENTAL
  2. description
    7800 cGy / 39 fractions in 8 weeks
    intervention Names
    1. Procedure: 7800 cGy/39 fractions in 8 weeks
    label
    2
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. 2
    description
    see above
    name
    7800 cGy/39 fractions in 8 weeks
    other Names
    1. standard
    type
    PROCEDURE
  2. arm Group Labels
    1. 1
    description
    see above
    name
    6000 cGy/20 fractions in 4 weeks
    other Names
    1. short fractionation schedule
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
1204
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Biochemical (PSA) Failure
    time Frame
    five years
secondary Outcomes
  1. measure
    Biochemical-Clinical Failure
    time Frame
    five years
  2. measure
    Prostate Cancer Specific Mortality
    time Frame
    five years
  3. measure
    Toxicity
    time Frame
    five years
  4. measure
    Quality of Life
    time Frame
    five years
Full study description
brief Summary
This trial is designed to determine whether an 8-week course of escalated dose conformal radiation can be compressed safely, and with similar efficacy into a 4-week course.
detailed Description
In this trial, men with intermediate risk prostate cancer will be randomized to a shorter course of radiotherapy (6000cGy in 20 fractions over 4 weeks-hypofractionated) or treatment with a conventional fractionation course (7800cGy in 39 fractions over 8 weeks-standard). Three-dimensional conformal radiation treatment techniques, including intensity modulated radiotherapy will be used for both hypofractionated and standard treatments to avoid normal tissue exposure to radiation and minimize the risk of acute and late treatment related toxicity. The primary outcome measure is biochemical (PSA) failure defined by the ASTRO consensus criteria. Secondary outcomes include biochemical-clinical failure (BCF), mortality from cancer, toxicity and health-related quality of life. It is planned to recruit 1204 patients to the study. If the safety and efficacy of the shorter course are demonstrated, then its adoption would reduce the social, emotional and economic burden of treatment for patients and their families.
Source references
references
  1. citation
    Martin J, Frantzis J, Chung P, Langah I, Crain M, Cornes D, Plank A, Finch T, Jones M, Khoo E, Catton C. Prostate radiotherapy clinical trial quality assurance: how real should real time review be? (A TROG-OCOG Intergroup Project). Radiother Oncol. 2013 Jun;107(3):333-8. doi: 10.1016/j.radonc.2013.05.015. Epub 2013 Jun 8.
    pmid
    23751377
    type
    BACKGROUND
  2. citation
    Sanmamed N, Dayes I, Catton C, Liu A, Supiot S, Lukka H, Bauman G, Liu Z, Bahary JP, Ahmed S, Cheung P, Parliament M, Sia M, Tsakiridis T, Siva S, Corbett T, Tang C, Craig T, Martin J, Chung P. Patient-reported Quality of Life in PROFIT, a Phase 3 Randomized Clinical Trial Evaluating Moderately Hypofractionated Radiotherapy for Intermediate-risk Prostate Cancer. Eur Urol Oncol. 2026 Feb;9(1):26-36. doi: 10.1016/j.euo.2025.03.017. Epub 2025 May 6.
    pmid
    40335398
    type
    DERIVED
  3. citation
    Lange M, Campion L, Ollivier L, Renouf M, Magne N, Latorzeff I, Pommier P, Martin E, Paumier A, Bera G, Catton C, Martin J, Supiot S. Patterns of Relapse Following Radiation Therapy of Intermediate-Risk Prostate Cancer in the PROFIT Randomized Trial. Int J Radiat Oncol Biol Phys. 2025 Jun 1;122(2):399-406. doi: 10.1016/j.ijrobp.2025.01.030. Epub 2025 Feb 4.
    pmid
    39914555
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-de46bbd0e5fbce7be6da
      requested nct id
      NCT00304759
      primary nct id
      NCT00304759
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
      89c3cbcb10a3e14c5ee4b607046c929e5902a798e71e758f8a712b0ae71413cf
      payload sha256
      2bba82b487798ef00ae608ba69736bc08e9b8893bc8c4ea2d786f8c144da05e7
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-de46bbd0e5fbce7be6da
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT00304759
      occurrences
      1. context exact
        oward worse late GU grade 2 or higher toxicity: 29.7% versus 22.8% (<em>P</em> = .06).</li></ul></div></li><li>In a multicenter trial (<a href="/clinicaltrials/NCT00304759">NCT00304759</a>), 1,206 men with intermediate-risk prostate cancer (T1&#8211;2a Gleason score &#8804;6, PSA 10.1&#8211;20 ng/mL; T2b&#8211;2c Gleason &#8804;6
        end
        183386
        exact text
        NCT00304759
        start
        183375
      2. context exact
        ate GU grade 2 or higher toxicity: 29.7% versus 22.8% (<em>P</em> = .06).</li></ul></div></li><li>In a multicenter trial (<a href="/clinicaltrials/NCT00304759">NCT00304759</a>), 1,206 men with intermediate-risk prostate cancer (T1&#8211;2a Gleason score &#8804;6, PSA 10.1&#8211;20 ng/mL; T2b&#8211;2c Gleason &#8804;6, PSA &#8804;
        end
        183399
        exact text
        NCT00304759
        start
        183388
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/nci/raw/48a3f061dd2bbd22e8.html
      source file sha256
      89c3cbcb10a3e14c5ee4b607046c929e5902a798e71e758f8a712b0ae71413cf
      source json pointer
      Source null
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source retrieved at
      2026-09-09T23:22:14.334045+00:00
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      351f45145a6c8591cdadd072763243033f8e1fa33cafecd55e4bac86e2b9edf3
      source title
      Prostate Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 14, 2025
        datetime
        2025-05-14T12:00:00Z
        display
        May 14, 2025

    Preserved source evidence · Not medical advice