Hypofractionated Whole Pelvic Radiotherapy of the Prostate

NCT02546427 | Withdrawn DMC

• 1 other identifier: 15551
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase I feasibility study to evaluate the feasibility of hypofractionated whole pelvis radiotherapy in 35 patients with biopsy-proven intermediate- to high-risk prostate cancer as defined by NCCN risk criteria. Patients will have \>15% risk of lymph node involvement as defined by the Roach equation 2/3(PSA)+10(Gleason Score-6). Day 0 of the study will be defined as the time of first LHRH/agonist/antagonist injection of hormone therapy. Radiation therapy should begin within 8 weeks (+/- 1 week) after the date of the first LHRH agonist/antagonist injection. Patients will be followed at 6 weeks and then every 3 months for the first 24 months after completion of radiotherapy in a similar schedule to usual standard of care. A history and physical, PSA, testosterone and EPIC-26 questionnaire will be collected at each visit. Any toxicity according to CTCAE v. 4.0 criteria will be documented. An interim analysis for evaluating acute toxicity (≤90 days) will be performed after the first follow-up visit of the20th patient enrolled on protocol. The trial will be terminated if \>30% acute grade 2 or \>5% grade 3 or greater toxicity is observed as a result of radiation treatment by CTCAE v. 4.0 criteria. Grade 2 toxicity is defined as a minimal, local or noninvasive intervention. Grade 3 toxicity is defined as a severe or medically significant but not immediately life-threatening event requiring hospitalization or prolongation of hospitalization. Previous studies have demonstrated approximately 30% and 5% incidence of Grade 2 and Grade 3 or greater toxicity, respectively, with conventionally fractionated radiotherapy followed by brachytherapy.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Toxicity

  Acute G3 or greater genitourinary or gastrointestinal toxicity as measured by CTCAE v.4

  90 days post treatment

Secondary Outcomes (3)

• Late Toxicity

  From 90 days post treatment until 36 months from start of therapy

• High-Related Quality of Life (HRQOL)

  Baseline, week prior to RT, 6 weeks post treatment, and at least every 6 months for the first 2 years.

• PSA Complete Response (PSA-CR)

  120-127 days after initiation of therapy

Study Arms (1)

Treatment

EXPERIMENTAL

Step 1: Pelvic Lymph Node Irradiation Helical TomoTherapy (HT): 41.25 Gy in 15 fractions of 2.75 Gy each Step 2: Treat boost volume to prostate and seminal vesicles Acceptable treatment modalities: CyberKnife SBRT: 19 Gy in 2 fractions of 9.5 Gy each with SBRT Permanent prostate implant (PPI): 108 Gy for low dose rate PPI with I-125 90 Gy for low dose rate PPI with Pd-103 HDR brachytherapy: 15 Gy in one fraction for HDR

Radiation: Helical TomoTherapy (HT); Radiation: CyberKnife SBRT; Radiation: Permanent Prostate Implant (PPI); Radiation: HDR brachytherapy

Interventions

Helical TomoTherapy (HT) RADIATION

Treatment

CyberKnife SBRT RADIATION

Treatment

Permanent Prostate Implant (PPI) RADIATION

Treatment

HDR brachytherapy RADIATION

Treatment

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b, PSA \>10, and/or Gleason score ≥ 7) who have a greater than 15% risk of lymph node involvement as determined by the Roach equation.
• History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration
• Zubrod performance status 0-2
• Age ≥18 years
• Ability to understand a written informed consent document, and the willingness to sign it

You may not qualify if:

• Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years.
• Evidence of distant metastases
• Regional lymph node involvement
• Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
• Previous pelvic irradiation, prostate brachytherapy
• Previous or concurrent cytotoxic chemotherapy for prostate cancer
• Patients with history of inflammatory bowel disease or major bowel surgery.
• Prior transurethral resection of the prostate (TURP) procedure.

Sponsors & Collaborators

• Albert J. Chang: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

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)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 10, 2015
• Study Start: December 9, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2022
• Last Updated: February 12, 2018

Record last verified: 2018-02