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Trial record 80 of 1545 for:    Androgens

Hypofractionated Radiation Therapy in Treating Participants With Prostate Cancer High-Risk Features Following Radical Prostatectomy

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ClinicalTrials.gov Identifier: NCT03570827
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Brief Summary:
This phase II trial studies how well hypofractionated radiation therapy works in treating participants with prostate cancer high-risk features following radical prostatectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

Condition or disease Intervention/treatment Phase
Prostate Adenocarcinoma PSA Level Less Than Two Stage IIB Prostate Cancer AJCC v8 Stage III Prostate Cancer AJCC v8 Stage IIIA Prostate Cancer AJCC v8 Stage IIIB Prostate Cancer AJCC v8 Stage IIIC Prostate Cancer AJCC v8 Drug: Androgen Suppression Radiation: Hypofractionated Radiation Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Hypofractionated Radiation Therapy for Prostate Cancer With High Risk Features After Radical Prostatectomy
Actual Study Start Date : May 8, 2018
Estimated Primary Completion Date : May 8, 2023
Estimated Study Completion Date : May 8, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Group I (hypofractionated radiation therapy)
Participants undergo hypofractionated radiation therapy over 15-30 minutes every other day over 2 weeks, for 5 treatments.
Radiation: Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Other Names:
  • Hypofractionated Radiotherapy
  • hypofractionation

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Experimental: Group II (radiation therapy, androgen suppression therapy)
Beginning 8-10 weeks before radiation therapy, participants receive androgen suppression therapy SC or IM for up to 6 months (at the discretion of the treating physician). Participants then undergo hypofractionated radiation therapy as Group I.
Drug: Androgen Suppression
Given androgen suppression therapy
Other Names:
  • androgen ablation
  • androgen deprivation

Radiation: Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Other Names:
  • Hypofractionated Radiotherapy
  • hypofractionation

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Experimental: Group III (radiation therapy, androgen suppression therapy)
Participants receive androgen suppression therapy as Group II for up to 18 months (at the discretion of the treating physician), then undergo hypofractionated radiation therapy over 15-30 minutes every other day over 1-2 weeks, for 1-5 treatments.
Drug: Androgen Suppression
Given androgen suppression therapy
Other Names:
  • androgen ablation
  • androgen deprivation

Radiation: Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Other Names:
  • Hypofractionated Radiotherapy
  • hypofractionation

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Freedom from failure (FF) defined as the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), the start/re-start of salvage therapy including androgen suppression, and biochemical failure (PSA >= 0.5 ng/ml) [ Time Frame: Up to 5 years ]
    Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.


Secondary Outcome Measures :
  1. Acute grade 2 or higher and grade 3 or higher genitourinary (GU) and gastrointestinal (GI) toxicity performed using National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4 criteria [ Time Frame: Up to 5 years ]
    Descriptive measurements of frequency will be compiled. The maximum grade for each type of acute adverse events (AE) will be recorded for each patient. Data will be summarized as frequencies and relative frequencies. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. Similarly, grade 3 or higher GU and GI events will be estimated along with overall toxicity.

  2. Grade 2 or higher and grade 3 or higher GI and GU toxicity performed using NCI-CTCAE version 4 criteria [ Time Frame: 3 years ]
    The maximum grade for each type of acute adverse events (AE) will be recorded for each patient. Data will be summarized as frequencies and relative frequencies. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. Similarly, grade 3 or higher GU and GI events will be estimated along with overall toxicity.

  3. Local/distant failure [ Time Frame: Start of treatment assessed up to 5 years ]
    Will be measured from the date of the start of treatment to the date of documented local failure as determined either by clinical exam, imaging, or by prostate rebiopsy.

  4. Distant metastasis [ Time Frame: Up to 5 years ]
    Will be assessed using AJCC STAGING SYSTEM- PROSTATE, 8TH EDITION

  5. Quality of life (QOL) items from the Expanded Prostate Cancer Index Composite [ Time Frame: Up to 5 years ]

    Summation of relative scores for quality of life items from the Expanded Prostate Index Composite (EPIC) instrument will be used to measure each individual's quality of life. The difference in mean scores will be assessed with the t-test. To assess changes in health-related QOL from baseline, a clinically significant difference will be defined as half of a standard deviation (SD) and at least a 10-point change. Scale score trajectories over time will be examined using stream plots and mean plots with standard deviation error bars overall. Analysis will include percent change from baseline using t-tests and generalized linear models to test for changes at each time point and non-zero slope respectfully.

    EPIC is a validated instrument that measures urinary, bowel, and sexual function and bother. To statistically evaluate change over time, responses will be grouped by system and assigned a numeric score. The difference in mean scores will be assessed with the t-test.


  6. Impotence [ Time Frame: Up to 3 years ]

    Summation of relative scores for sexual function items (items 31 through 39) from the Expanded Prostate Index Composite (EPIC) instrument will be used to measure each individual's quality of life. Will be estimated as the number of patients experiencing the event of interest divided by the total number of evaluable patients. 95% confidence intervals will be calculated for each estimate.

    EPIC is a validated instrument that measures urinary, bowel, and sexual function and bother. To statistically evaluate change over time, responses will be grouped by system and assigned a numeric score. The difference in mean scores will be assessed with the t-test.


  7. Salvage androgen suppression use [ Time Frame: Up to 5 years ]
    Will be estimated as the number of patients experiencing the event of interest divided by the total number of evaluable patients. 95% confidence intervals will be calculated for each estimate.

  8. Overall survival [ Time Frame: Up to 5 years ]
    Will be estimated with a Kaplan-Meier estimator and curve. Estimates will be given for specific time points along with 95% confidence intervals (CIs).

  9. Progression free survival [ Time Frame: Up to 5 years ]
    Will use clinical, biochemical and SAD as events. Will be estimated with a Kaplan-Meier estimator and curve. Estimates will be given for specific time points along with 95% CIs.

  10. Disease-free survival [ Time Frame: Up to 5 years ]
    Will be estimated with a Kaplan-Meier estimator and curve. Estimates will be given for specific time points along with 95% CIs.

  11. Freedom from biochemical failure (FFBF) [ Time Frame: Up to 5 years ]
    Will be estimated as the number of patients experiencing the event of interest divided by the total number of evaluable patients. 95% confidence intervals will be calculated for each estimate.


Other Outcome Measures:
  1. Development of quality assurance process for prostate proton therapy [ Time Frame: Up to 5 years ]
    Will perform physics check according to Sec 7.12 of protocol.

  2. Pathologic and radiologic findings [ Time Frame: Up to 5 years ]
    Correlated with outcome (AJCC Criteria 8th Ed.- appendix II)

  3. Estimation of prostate and normal structure movement [ Time Frame: Up to 5 years ]
    during radiation therapy (RT) with the use of scans. Data will be summarized by frequencies and mean (SD) or median values.

  4. Dose volume relationship of normal structures with toxicity [ Time Frame: Up to 5 years ]
  5. Potentially, future research of pathologic risk factors [ Time Frame: Up to 5 years ]
    Allow for future research of pathologic risk factors that may influence prognosis; this information will help us to attempt to characterize their presence in prostate cancer with high risk features after prostatectomy and their potential effect on outcomes.

  6. Possible comparison of an intensity-modulated radiation therapy (IMRT) plan with the proton therapy radiation plan [ Time Frame: Up to 5 years ]
    Proton therapy and x-ray dosimetry levels will be compared to outcomes and described in Groups I/II and III separately. Data will be summarized by frequences and mean (SD) or median values. Continuous variable will be compared using unpaired t tests and nonimal variables will be compared using contingency tables and Chi square analyses.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed prostate adenocarcinoma at the time of surgery
  • Pathologic stages T2-T3b, N0-Nx-N1, M0-1 as staged by the pathology report (American Joint Committee on Cancer [AJCC] criteria 8th edition [Ed.])
  • One or more high risk features including: seminal vesicle invasion, extracapsular extension, positive margins, or a PSA post surgery between 0.2 and < 2.0
  • PSA values < 2 ng/ml within 90 days prior to enrollment. Obtained at least 6 weeks after surgery
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2 assessed within 90 days of enrollment
  • Patients must sign Institutional Review Board (IRB) approved study specific informed consent
  • Patients must complete all required pre-entry tests within the specified time frames
  • Patients must be able to start treatment (androgen suppression [AS] or radiation) within 120 days of study registration
  • Positron emission tomography (PET) scan is suggested for a PSA >= 0.2 ngs/ml
  • Magnetic resonance imaging (MRI) pelvis, computed tomography (CT) pelvic, or bone scan for a PSA >= 0.2 ngs/ml may be done, based on the physician preference
  • Members of all races and ethnic groups are eligible for this trial
  • Patients from outside of the United States may participate in the study

Exclusion Criteria:

  • Previous pelvic radiation
  • Prior androgen suppression therapy for prostate cancer for more than 6 months
  • Active rectal diverticulitis, Crohn?s disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn?s disease not affecting the rectum are allowed)
  • Prior systemic chemotherapy for prostate cancer
  • History of proximal urethral stricture requiring dilatation
  • Current and continuing anticoagulation with warfarin sodium (coumadin), heparin, low- molecular weight heparin, Clopidogrel bisulfate (plavix), or equivalent (unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or place markers)
  • Major medical, addictive or psychiatric illness which in the investigator?s opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized representative is not permitted for this study)
  • Evidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed)
  • History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570827


Locations
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United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Carlos E. Vargas, M.D.         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Carlos Vargas Mayo Clinic

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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT03570827     History of Changes
Other Study ID Numbers: MC1754
NCI-2018-00943 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC1754 ( Other Identifier: Mayo Clinic in Arizona )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Androgens
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Ascorbic Acid
Methyltestosterone
Estrogens, Conjugated (USP)
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents