ACTIVE_NOT_RECRUITING

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

Conditions

Prostate Cancer Radiation Therapy Hypofractionation Radiotherapy Extended Hypofractionation Radiotherapy Accelerated Hypofractionation Radiotherapy AHRT EHRT

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 four-year biochemical failure (PSA failure) by Phoenix definition post-treatment completion.

Official Title

A Randomized Study of Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) For Prostate Cancer

Quick Facts

Study Start:2013-04-04

Study Completion:2027-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT01794403

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years to 85 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Histologically proven prostate adenocarcinoma. * Gleason score 2-7 (reviewed by reference lab at UM). * Biopsy within one year of date of enrollment. 2. 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. 3. Prostate-Specific Antigen (PSA) \< 20 ng/ml, obtained no greater than 3 months prior to enrollment. 4. 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. 5. Prostate volume: ≤ 80 cc. * Determined using: volume = π/6 x length x height x width. * Measured from CT or MRI ≤90 days prior to enrollment. 6. Zubrod performance status 0-1. 7. No prior total prostatectomy or cryotherapy of the prostate. * Prior suprapubic prostatectomy, transurethral resection and laser ablation are permitted. 8. No prior radiotherapy to the prostate or lower pelvis. 9. No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion. 10. No chemotherapy for a malignancy in the last 5 years. 11. No history of an invasive malignancy (other than this prostate cancer, or nonmetastatic basal or squamous skin cancers) in the last 5 years. 12. 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. 13. 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. 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. fourth dimensional (4D) transperitoneal ultrasound, onboard MRI guidance). 14. Ability to understand and the willingness to sign a written informed consent document. 15. Willingness to fill out quality of life/psychosocial forms. 16. Age \>= 35 and =\< 85 years. 17. International Prostate Symptom Index (IPSS) (AUA) score ≤12	1. Does not have a diagnosis of prostate adenocarcinoma. 2. Patient has clinical T3a or any evidence of T3b disease. 3. Patient has stage N1 or M1 disease. 4. Patients has a PSA of greater than 20 ng/ml, obtained no greater than 3 months prior to randomization. 5. Patient does not meet any of the risk groups outlined in section 3.1.4. 6. Prostate volume greater than 80 cc. 7. Zubrod performance status 2 or greater. 8. Prior total prostatectomy. 9. Prior radiation therapy to the prostate or lower pelvis. 10. Implanted hardware which limits treatment planning or delivery (determined by the investigator). 11. Chemotherapy within the past 5 years. 12. 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). 13. 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. 14. 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). 15. Unwilling or inability to give informed consent. 16. Not willing to fill out quality of life/psychosocial questionnaires. 17. IPSS score \> to 12. 18. Age \< 35 and \> 85 years.

Inclusion Criteria

Exclusion Criteria

1. Histologically proven prostate adenocarcinoma.
* Gleason score 2-7 (reviewed by reference lab at UM).
* Biopsy within one year of date of enrollment.
2. 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.
3. Prostate-Specific Antigen (PSA) \< 20 ng/ml, obtained no greater than 3 months prior to enrollment.
4. 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.
5. Prostate volume: ≤ 80 cc.
* Determined using: volume = π/6 x length x height x width.
* Measured from CT or MRI ≤90 days prior to enrollment.
6. Zubrod performance status 0-1.
7. No prior total prostatectomy or cryotherapy of the prostate.
* Prior suprapubic prostatectomy, transurethral resection and laser ablation are permitted.
8. No prior radiotherapy to the prostate or lower pelvis.
9. No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
10. No chemotherapy for a malignancy in the last 5 years.
11. No history of an invasive malignancy (other than this prostate cancer, or nonmetastatic basal or squamous skin cancers) in the last 5 years.
12. 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.
13. 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. 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. fourth dimensional (4D) transperitoneal ultrasound, onboard MRI guidance).
14. Ability to understand and the willingness to sign a written informed consent document.
15. Willingness to fill out quality of life/psychosocial forms.
16. Age \>= 35 and =\< 85 years.
17. International Prostate Symptom Index (IPSS) (AUA) score ≤12

1. Does not have a diagnosis of prostate adenocarcinoma.
2. Patient has clinical T3a or any evidence of T3b disease.
3. Patient has stage N1 or M1 disease.
4. Patients has a PSA of greater than 20 ng/ml, obtained no greater than 3 months prior to randomization.
5. Patient does not meet any of the risk groups outlined in section 3.1.4.
6. Prostate volume greater than 80 cc.
7. Zubrod performance status 2 or greater.
8. Prior total prostatectomy.
9. Prior radiation therapy to the prostate or lower pelvis.
10. Implanted hardware which limits treatment planning or delivery (determined by the investigator).
11. Chemotherapy within the past 5 years.
12. 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).
13. 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.
14. 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).
15. Unwilling or inability to give informed consent.
16. Not willing to fill out quality of life/psychosocial questionnaires.
17. IPSS score \> to 12.
18. Age \< 35 and \> 85 years.

Contacts and Locations

Principal Investigator

Matthew Abramowitz, MD

PRINCIPAL_INVESTIGATOR

University of Miami

Alan Pollack, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: University of Miami

Matthew Abramowitz, MD, PRINCIPAL_INVESTIGATOR, University of Miami
Alan Pollack, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-04-04

Study Completion Date2027-02-01

Study Record Updates

Study Start Date2013-04-04

Study Completion Date2027-02-01

Terms related to this study

Keywords Provided by Researchers

Radiation Therapy
Hypofractionation Radiotherapy
Extended Hypofractionation Radiotherapy
Accelerated Hypofractionation Radiotherapy
AHRT
EHRT

Additional Relevant MeSH Terms

Prostate Cancer