Phase I/II Hypofractionated Radiotherapy for Prostate Cancer

NCT00214097 | Completed Phase 1 Results DMC

• 5 other identifiers: RO02803NCI (P01 CA88960)2002-322A533300SMPH/HUMAN ONCOLOGY
• Study Type: interventional
• Target: 347
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Biochemical Progression-free Survival Based on PSA Surveillance

  up to 15 years from enrollment

• Fox Chase Bowel Survey at Baseline and 3 Years

  Baseline and 3 years

• Fox Chase Bladder Survey at Baseline and 3 Years

  Baseline and 3 years

• International Index of Erectile Function (IIEF) Score at Baseline and 3 Years

  Baseline and 3 years

• Spritzer Quality of Life Index (SQLI) at Baseline and 3 Years

  Baseline and 3 years

Study Arms (3)

Level 1

EXPERIMENTAL

64.7 Gy/22 fractions of 2.94 Gy

Radiation: Radiotherapy

Level 2

EXPERIMENTAL

58.08 Gy/16 fractions of 3.63 Gy

Radiation: Radiotherapy

Level 3

EXPERIMENTAL

51.6 Gy/12 fractions of 4.3 Gy

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

Daily radiation to prescribed dose

Level 1; Level 2; Level 3

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related 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. doi: 10.1016/j.radonc.2015.12.018. Epub 2016 Jan 2.

  PMID: 26755165 RESULT

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Diana Trask
• Organization: University of Wisconsin

trask@humonc.wisc.edu

608-263-9528

Study Officials

• Mark Ritter, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: October 14, 2002
• Primary Completion: August 21, 2017
• Study Completion: August 21, 2017
• Last Updated: November 25, 2019
• Results First Posted: October 22, 2019

Record last verified: 2019-09

Locations

US (1)