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Trial record 43 of 1543 for:    Androgens

Androgen Suppression With Stereotactic Body or External Beam Radiation Therapy (ASSERT) (ASSERT)

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ClinicalTrials.gov Identifier: NCT02594072
Recruitment Status : Recruiting
First Posted : November 2, 2015
Last Update Posted : April 30, 2019
Sponsor:
Collaborator:
British Columbia Cancer Agency
Information provided by (Responsible Party):
Abraham Alexander, University of British Columbia

Brief Summary:
Two radiation therapy techniques are commonly used for the treatment of intermediate and high risk prostate cancer: brachytherapy and external beam radiation therapy (EBRT). However, both have limitations. Brachytherapy, in which radioactive seeds are inserted into the prostate, produces excellent outcomes but is invasive and not all patients are eligible or willing to receive this treatment. EBRT, while gentle at the time of delivery, tends to be very prolonged and may have poorer outcomes than brachytherapy. This study will examine the use of stereotactic ablative radiotherapy (SABR), in which patients are given only a few, high dose radiation treatments. Treatments are short, non-invasive, applicable to patients not able to do brachytherapy, and may be more effective than conventional EBRT. This study will compare SABR with EBRT in terms of the rates of acute and late toxicities for each treatment, disease-free survival, and health-related quality of life measures.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: stereotactic ablative radiotherapy Radiation: external beam radiation therapy Drug: Zoladex ® Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Androgen Suppression With Stereotactic Body or External Beam Radiation Therapy (ASSERT): A Phase II Randomized Trial for Intermediate and High Risk Prostate Cancer
Study Start Date : April 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: SABR with androgen suppression
Stereotactic ablative radiotherapy (SABR) with a prescribed dose of 36.25 Gy in 5 fractions over 5 weeks (one treatment day per week). Zoladex ® for androgen suppression, taken for 6 months for patients with intermediate-risk prostate cancer, 18 months for patients with high-risk prostate cancer.
Radiation: stereotactic ablative radiotherapy
Linac-based prostate stereotactic radiotherapy, using Volumetric Modulated Arc Therapy planning and delivery, with fiducial marker and cone-beam CT based image guidance.

Drug: Zoladex ®
The preferred agent for the protocol is goserelin acetate (Zoladex ®) 3-month depot, but other LHRH agonists are permitted. The total duration of ADT will be 6 months for men with intermediate risk disease, and 18 months for those with high risk disease. ADT is to be initiated prior to the start of RT.
Other Name: goserelin acetate

Active Comparator: EBRT with androgen suppression
Conventional external beam radiation therapy (EBRT) with a prescribed dose of 73.68 Gy in 28 fractions (5 treatment days per week over 5.5 weeks). Zoladex ® for androgen suppression, taken for 6 months for patients with intermediate-risk prostate cancer, 18 months for patients with high-risk prostate cancer.
Radiation: external beam radiation therapy
Conventional intensity modulated radiotherapy, with fiducial marker or cone-beam CT based image guidance.

Drug: Zoladex ®
The preferred agent for the protocol is goserelin acetate (Zoladex ®) 3-month depot, but other LHRH agonists are permitted. The total duration of ADT will be 6 months for men with intermediate risk disease, and 18 months for those with high risk disease. ADT is to be initiated prior to the start of RT.
Other Name: goserelin acetate




Primary Outcome Measures :
  1. Number of subjects experiencing treatment-related acute and late toxicities, focussing on grade 3 and 4 complications, as assessed by the NCI CTCAEv4 and modified RTOG/SOMA toxicity scale. [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Number of subjects with biochemical relapse free survival at five years as measured by PSA levels. [ Time Frame: 5 years ]
  2. To compare the health related quality of life as reflected in changes on the EPIC questionnaire between the two interventions [ Time Frame: 5 years ]
  3. To measure the mean prostate pre-fraction to post-fraction displacement, in millimeters, from CT scans done pre- and post-fraction. [ Time Frame: at week 5 of radiotherapy (completion of radiotherapy) ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathological diagnosis of prostate cancer within 365 days prior to registration.
  2. Disease must be Canadian Consensus (GUROC) high and intermediate risk with probability of pelvic nodal involvements <15% by the Updated Partin Tables.

    • High risk is defined by any of: ≥T3a, PSA > 20, or Gleason ≥ 8
    • Intermediate risk is defined by: T1/T2 and/or Gleason ≤ 7 and/or PSA ≤20 and not low risk
  3. Disease must be T1 or T2 clinically
  4. Prostate specific antigen (PSA) and testosterone level (TTT) must be done not more than 60 days before registration. If androgen deprivation therapy is started before registration, PSA and TTT should be done not more than 60 days prior to commencement of androgen deprivation therapy.
  5. For high risk patients, negative pelvis CT scan and bone scan for metastases not more than 60 days before registration. If androgen deprivation therapy is started before registration, pelvis CT scan and bone scan should be done not more than 60 days prior to commencement of androgen deprivation therapy. For intermediate risk patients, pelvis CT scan and bone scan are optional.
  6. Commencement of androgen deprivation therapy is allowed before registration. However, the lead time must allow for completion of the radiation treatment within 6 months and 18 months of the androgen deprivation therapy treatment duration for intermediate and high risk disease respectively.
  7. History/physical examination with digital rectal examination of the prostate within 60 days of registration or commencement of androgen deprivation therapy.
  8. Life expectancy of at least 5 years
  9. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
  10. No contraindication for 6 months and 18 months of androgen deprivation therapy respectively for intermediate and high risk disease.

Exclusion Criteria:

  1. Clinical evidence of extra-prostatic disease extension
  2. Clinical evidence of prostate volume > 90 cc prior to randomization
  3. Prior history of inflammatory bowel disease
  4. Prior history of invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. All patients with in situ carcinoma are eligible for this study (for example, carcinoma in situ of the oral cavity is eligible) except patients with carcinoma of the bladder (including in situ bladder cancer or superficial bladder cancer).
  5. Previous pelvic radiation
  6. Presence of a hip prosthesis
  7. Evidence of pelvic nodal involvement or distant metastases

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): NCT02594072


Contacts
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Contact: Abraham Alexander, MD 250-519-5575 AAlexander3@bccancer.bc.ca
Contact: Winkle Kwan, MD 604-930-4085 WKwan@bccancer.bc.ca

Locations
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Canada, British Columbia
BC Cancer Agency Fraser Valley Center Recruiting
Surrey, British Columbia, Canada, V3V1Z2
Contact: Winkle Kwan, MD FRCPC    604 930 4085    WKwan@bccancer.bc.ca   
BC Cancer Agency Vancouver Island Center Recruiting
Victoria, British Columbia, Canada, V8R6V5
Contact: Abrahaam S Alexander, MD FRCPC    250 519 5575    aalexander3@bccancer.bc.ca   
Sponsors and Collaborators
University of British Columbia
British Columbia Cancer Agency
Investigators
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Principal Investigator: Abraham Alexander, MD British Columbia Cancer Agency
Principal Investigator: Winkle Kwan, MD British Columbia Cancer Agency

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Responsible Party: Abraham Alexander, Clinical assistant professor, Radiation Oncologist, University of British Columbia
ClinicalTrials.gov Identifier: NCT02594072     History of Changes
Other Study ID Numbers: ASSERT
First Posted: November 2, 2015    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Androgens
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Ascorbic Acid
Methyltestosterone
Goserelin
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