Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) For Prostate Cancer

  • STATUS
    Recruiting
  • End date
    Mar 28, 2023
  • participants needed
    456
  • sponsor
    University of Miami
Updated on 28 June 2020
Investigator
Thomas Eade, M.B.B.S.
Primary Contact
Northern Sydney Local Health District - Royal North Shore Hospital (4.8 mi away) Contact
+3 other location
prostatectomy
androgens
cryotherapy
metastasis
antiandrogen therapy
androgen suppression
bone scan
prostate specific antigen
digital rectal exam
adenocarcinoma
digital rectal examination
adenocarcinoma of prostate
hypofractionated radiation therapy

Summary

Accelerated Hypofractionation Radiotherapy for prostate cancer of 36.25 Gy delivered in 5 fractions will not be inferior to the standard treatment of 70.2 Gy given in 26 fractions with respect to two-year failure defined as a positive biopsy two years post treatment completion or earlier evidence of biochemical or clinical failure.

Details
Treatment Extended Hypofractionation Radiotherapy, Accelerated Hypofractionation Radiotherapy, Expanded Prostate Cancer Index Composite SF-12, International Prostate Symptom Score, Memorial Anxiety Scale for Prostate Cancer patients
Clinical Study IdentifierNCT01794403
SponsorUniversity of Miami
Last Modified on28 June 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 35 yrs and 85 yrs?
Are you male?
Do you have any of these conditions: Prostate Cancer or Prostate Disorders or Prostatic disorder or Prostate Cancer, Early, Recurrent or Malignant neoplasm of prostate?
Histologically proven prostate adenocarcinoma
Gleason score 2-7 (reviewed by reference lab at UM)
Biopsy within one year of date of enrollment
Clinical stage T2 based on DRE and/or T3a based on MRI (if done); N0-Nx; M0-Mx (AJCC 7th Edition)
T-stage and N-stage determined by physical exam and available imaging studies (CT, and/or MRI of the pelvis; see section 4.5). For MRI, questionable extracapsular extension is permitted. To distinguish blood from tumor the ideal study would be to acquire T2, T1 noncontrast and T1 dynamic contrast enhanced sequence, although this is not required. A small amount of extracapsular extension is permitted, as long as it can be included in the clinical target volume (CTV) and the constraints are met
M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases
Prostate-Specific Antigen (PSA) < 20 ng/ml, obtained no greater than 3 months prior to enrollment
Patients belonging in one of the following risk groups
Low
Clinical stage T1-T2; Gleason 6, PSA 10 & <50% biopsy cores positive
Intermediate
Clinical stage T2b-T2c; Gleason 6, PSA 10 & <50% biopsy cores positive
Clinical stage T1-T2; Gleason 6, PSA 10 & 50% biopsy cores positive
Clinical stage T1-T2; Gleason = 7, PSA 10 & <50% biopsy cores positive or T1-T2; Gleason 6 & PSA >10 and < 20 & < 50% biopsy cores positive
MRI stage T3a with evidence of extraprostatic extension is allowed
Clinical stage is based on digital rectal exam (DRE). Seminal vesicle invasion on MRI is not eligible. T1a should be permitted if subsequent peripheral zone biopsies show tumor
Prostate volume: 80 cc
Determined using: volume = /6 x length x height x width
Measured from CT or MRI 90 days prior to enrollment
Zubrod performance status 0-1
No prior total prostatectomy or cryotherapy of the prostate
Prior suprapubic prostatectomy, transurethral resection and laser ablation are permitted
No prior radiotherapy to the prostate or lower pelvis
No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion
No chemotherapy for a malignancy in the last 5 years
No history of an invasive malignancy (other than this prostate cancer, or nonmetastatic basal or squamous skin cancers) in the last 5 years
4-6 months of androgen deprivation therapy (ADT) are allowed for intermediate risk patients. This must be declared prior to randomization. This may not have been started more than 2 months prior to randomization
Patient must be able to have gold fiducial markers placed in the prostate (if on anticoagulants, must be cleared by a primary care physician or cardiologist), or if patient already has fiducial marker placed, they must be in accordance with the protocol specifications (Section 4.2.2). NOTE: If a method of intrafraction prostate tracking is available which does not require fiducial markers, this will be adequate for this trial (i.e. 4D transperitoneal ultrasound, onboard MRI guidance)
Ability to understand and the willingness to sign a written informed consent document
Willingness to fill out quality of life/psychosocial forms
Age >= 35 and =< 85 years
IPSS (AUA) score 12

Exclusion Criteria

Does not have a diagnosis of prostate adenocarcinoma
Patient has clinical T3a or any evidence of T3b disease
Patient has stage N1 or M1 disease
Patients has a PSA of greater than 20 ng/ml, obtained no greater than 3 months prior to randomization
Patient does not meet any of the risk groups outlined in section 3.1.4
Prostate volume greater than 80 cc
Zubrod performance status 2 or greater
Prior total prostatectomy
Prior radiation therapy to the prostate or lower pelvis
Implanted hardware which limits treatment planning or delivery (determined by the investigator)
Chemotherapy within the past 5 years
Diagnosis of an invasive malignancy within 5 years (other than current prostate cancer or non-metastatic basal or squamous skin cancers or non-metastatic curatively treated papillary thyroid carcinoma)
The use of more than 2 months of androgen deprivation therapy (ADT) prior to randomization, or plans for ADT to be continued for greater than 6 months
Inability to have gold fiducial markers placed in the prostate, or fiducial markers already placed that are not in accordance with the protocol (Section 4.2.2). NOTE: If a method of intrafraction prostate tracking is available which does not require fiducial markers, this will be adequate for this trial (i.e. 4D transperitoneal ultrasound, onboard MRI guidance)
Unwilling or inability to give informed consent
Not willing to fill out quality of life/psychosocial questionnaires
IPSS score > to 12
Age < 35 and > 85 years
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