Hypofractionated Whole Pelvic Radiotherapy of the Prostate

Albert J. Chang

Status: Withdrawn

Conditions: Prostate Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02546427

15551

Details and patient eligibility

About

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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Treatment

Experimental group

Description:

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

Treatment:

Radiation: HDR brachytherapy

Radiation: Helical TomoTherapy (HT)

Radiation: Permanent Prostate Implant (PPI)

Radiation: CyberKnife SBRT