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Completed

NCT Number: NCT00214097

Phase I/II Hypofractionated Radiotherapy for Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiotherapy

Radiation

Daily radiation to prescribed dose

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Phase I/II Trial Examining Dose-per-Fraction Escalation Using Intensity Modulated Radiation Therapy in the Treatment of Prostate Cancer

Important dates

Study start
2002
Primary completion
2017
Study completion
2017
First posted
Sep 21, 2005
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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