Phase I/II Hypofractionated Radiotherapy for Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00214097
• Other study ID #: RO02803
• Secondary ID: NCI (P01 CA88960
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 14, 2002
• Est. completion date: August 21, 2017

Study information

• Verified date: September 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: August 21, 2017
• Est. primary completion date: August 21, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Radiotherapy
Daily radiation to prescribed dose

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (1)

Brower JV, Forman JD, Kupelian PA, Petereit DG, Gondi V, Lawton CA, Anger N, Saha S, Chappell R, Ritter MA. Quality of life outcomes from a dose-per-fraction escalation trial of hypofractionation in prostate cancer. Radiother Oncol. 2016 Jan;118(1):99-104 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experience Grade 3 or Higher Acute Toxicities	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.	90 days post radiation treatment
Primary	Number of Subjects Experiencing Grade 2 or Higher Late Rectal Toxicities at Any Time During Follow Up	To evaluate late radiation toxicities to dose-per fraction escalation in the treatment of prostate	from 90 days post XRT through last follow-up visit (up to 3 years)
Secondary	Biochemical Progression-free Survival Based on PSA Surveillance	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	up to 15 years from enrollment
Secondary	Fox Chase Bowel Survey at 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.	Baseline and 3 years
Secondary	Fox Chase Bladder Survey at 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.	Baseline and 3 years
Secondary	International Index of Erectile Function (IIEF) Score at 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.	Baseline and 3 years
Secondary	Spritzer Quality of Life Index (SQLI) at 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.	Baseline and 3 years

External Links

•   University of Wisconsin Carbone Cancer Center