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Phase I/II Hypofractionated Radiotherapy for Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00214097
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : October 22, 2019
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The purpose of this study is to examine the clinical feasibility of using Intensity-modulated radiation therapy (IMRT) combined with daily pretreatment prostate localization to deliver increasingly hypofractionated treatment courses. Progressively larger fraction sizes will be delivered in a phase I design based on both acute and long-term tolerances to the treatment. The dose-per-fraction escalation design utilizes schemas that maintain an isoeffective dose for late effects, while predicting that tumor control will actually improve. The delivery of fewer, larger fractions of radiation, if proven effective and safe, would result in significant cost saving and more efficient use of resources. Phase II will commence with Maximum Tolerated Dose (MTD) finding with up to 200 additional patients being enrolled during this phase of the study.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Radiotherapy Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 347 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

dose escalation, 3 possible dose groups, with one Phase II group based on MTD.

Per protocol, while waiting for safety data to mature for escalation, protocol permitted enrollment to continue on last dose that was already proven safe. Thus Arms one and two have more than 50 subjects each.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial Examining Dose-per-Fraction Escalation Using Intensity Modulated Radiation Therapy in the Treatment of Prostate Cancer
Actual Study Start Date : October 14, 2002
Actual Primary Completion Date : August 21, 2017
Actual Study Completion Date : August 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Level 1
64.7 Gy/22 fractions of 2.94 Gy
Radiation: Radiotherapy
Daily radiation to prescribed dose

Experimental: Level 2
58.08 Gy/16 fractions of 3.63 Gy
Radiation: Radiotherapy
Daily radiation to prescribed dose

Experimental: Level 3
51.6 Gy/12 fractions of 4.3 Gy
Radiation: Radiotherapy
Daily radiation to prescribed dose




Primary Outcome Measures :
  1. Number of Participants Who Experience Grade 3 or Higher Acute Toxicities [ Time Frame: 90 days post radiation treatment ]
    To evaluate acute tolerances to dose-per-fraction escalation in the treatment of prostate cancer using optimized treatment of Intensity-modulated radiation therapy (IMRT), daily rectal balloon displacement, and transabdominal ultrasound localization of the prostate. For toxicities observed within the first 10 patients at each hypofractionation level, ≥20% acute grade 3 or higher GI or genitourinary (GU) toxicity will constitute a threshold toxicity level and will dictate a decrease in frequency of treatment by one treatment per week. Maximum tolerated dose is reached if 20% of participants experience acute toxicities grade 3 or higher.

  2. Number of Subjects Experiencing Grade 2 or Higher Late Rectal Toxicities at Any Time During Follow Up [ Time Frame: from 90 days post XRT through last follow-up visit (up to 3 years) ]
    To evaluate late radiation toxicities to dose-per fraction escalation in the treatment of prostate


Secondary Outcome Measures :
  1. Biochemical Progression-free Survival Based on PSA Surveillance [ Time Frame: up to 15 years from enrollment ]
    Patients will be considered to be without biochemical recurrence if either the Prostate-specific antigen (PSA) is still declining or the PSA nadir has been reached and is below 1.0ng/ml

  2. Fox Chase Bowel Survey at Baseline and 3 Years [ Time Frame: Baseline and 3 years ]
    The Fox Chase Bowel/Bladder survey was divided into two sections: Bowel (questions 1 to 14, N=14) and Bladder (questions 19, and 21 to 30, N=11). To facilitate analysis, Bowel and Bladder scores for each section were rescaled to a total score of between 0 - 100, where higher scores indicated better Quality of Life (QoL). Results for the Bowel Section are reported here.

  3. Fox Chase Bladder Survey at Baseline and 3 Years [ Time Frame: Baseline and 3 years ]
    The Fox Chase Bowel/Bladder survey was divided into two sections: Bowel (questions 1 to 14, N=14) and Bladder (questions 19, and 21 to 30, N=11). To facilitate analysis, Bowel and Bladder scores for each section were rescaled to a total score of between 0 - 100, where higher scores indicated better Quality of Life. Results for the Bladder Section are reported here.

  4. International Index of Erectile Function (IIEF) Score at Baseline and 3 Years [ Time Frame: Baseline and 3 years ]
    The IIEF is a 15-item survey where 9-items are scored 0-5 and 6-items are scored 1-5 with a total range of 6-75. The standard scoring mechanism was used for IIEF, where the QoL items corresponded to the following domains: erectile function (score range 1-30), orgasmic function (score range 1-10), sexual desire (score range 2-10), intercourse satisfaction (score range 0-15), and overall satisfaction (score range 2-10). Higher numbers indicate increased QoL.

  5. Spritzer Quality of Life Index (SQLI) at Baseline and 3 Years [ Time Frame: Baseline and 3 years ]
    The SQLI is composed of five items (activity, daily living, health, support, outlook) scored utilizing a numerical scale of 0-2. Standard scoring was also used for the SQLI survey (total score range 0-10) where higher score indicate increased QoL.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Histologically proven adenocarcinoma of the prostate.

  • Stage ≤ T2b disease, as defined by 1997 American Joint Committee on Cancer (AJCC) classification
  • Predicted risk of lymph node involvement (by standard nomograms) of 15% or less (24), OR histologically negative pelvic nodes
  • Gleason score ≤ 7
  • No evidence of distant metastasis
  • Age 18+
  • Informed consent signed in accordance with institutional protocol
  • Pretreatment evaluations must be completed as specified in Section 7.0.
  • ECOG performance status 0-1
  • No previous or concurrent cancers, other than localized basal cell or squamous cell skin carcinoma, unless continually disease free for at least 5 years
  • No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
  • Gonadotropin-releasing hormone agonist (GnRH-a) use permitted (maximum of 6 months duration). Anti-androgen therapy permitted concurrently with GnRH-a.
  • No previous or concurrent cytotoxic chemotherapy
  • No radical surgery or cryosurgery for prostate cancer
  • The absence of any co-morbid medical condition which would constitute a contraindication for radical radiotherapy
  • The absence of serious concurrent illness of psychological, familial, sociological, geographical or other concomitant conditions which do not permit adequate follow-up and compliance with the study protocol.
  • No current use of anticoagulation therapy, other than aspirin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00214097


Locations
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United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Mark Ritter, MD, PhD University of Wisconsin, Madison
  Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison:
Additional Information:
Publications of Results:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214097    
Other Study ID Numbers: RO02803
NCI (P01 CA88960)
2002-322 ( Other Identifier: Institutional Review Board )
A533300 ( Other Identifier: UW Madison )
SMPH/HUMAN ONCOLOGY ( Other Identifier: UW Madison )
First Posted: September 21, 2005    Key Record Dates
Results First Posted: October 22, 2019
Last Update Posted: November 25, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases