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Trial record 39 of 1543 for:    Androgens

Stereotactic Boost and Long-Term Androgen Deprivation for Adenocarcinoma of the Prostate (CCRO025)

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ClinicalTrials.gov Identifier: NCT02064036
Recruitment Status : Recruiting
First Posted : February 17, 2014
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:

We hypothesize that Stereotactic Body Radiotherapy Boost (SBRT) as a boost to the prostate following whole pelvic intensity modulated radiotherapy (IMRT) can be delivered effectively and safely in a population of men with unfavorable intermediate and high risk localized prostate cancer.

Our primary objective is to assess the feasibility and safety of a treatment strategy incorporating whole pelvic IMRT followed by an SBRT boost to the prostate with neoadjuvant, concurrent, and adjuvant androgen deprivation for a total of 28 months for men with unfavorable intermediate or high risk localized prostate cancer.


Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Prostate Radiation: Stereotactic Radiosurgical Boost Drug: Casodex Drug: Leuprolide Not Applicable

Detailed Description:

The primary objective of this study is to assess the feasibility and safety of a treatment strategy incorporating whole pelvic IMRT followed by an SBRT boost to the prostate with neoadjuvant, concurrent, and adjuvant androgen deprivation for a total of 28 months for men with unfavorable intermediate or high risk localized prostate cancer.

The secondary objective is to assess biochemical control at 24 months following the experimental treatment strategy by the "Phoenix definition". Patients not meeting these prostate-specific antigen (PSA) criteria (Phoenix Definition) for failure who undergo salvage therapies (such as androgen deprivation therapy (ADT), radical prostatectomy or brachytherapy, or Cryosurgery) should also be declared as failures at the time a positive biopsy is obtained or salvage therapy is administered, whichever comes first.

Another secondary objective is to assess toxicity of the experimental treatment approach as scored by the Common Terminology Criteria for Adverse Events The third secondary objective is to assess prostate organ motion during hypofractionated radiotherapy. To assess motion of the prostate during the protracted delivery of hypofractionated radiotherapy as assessed by implanted electromagnetic transponder beacons.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Whole-Pelvic Radiotherapy With a Stereotactic Body Radiotherapy Boost and Long-Term Androgen Deprivation for Unfavorable-Intermediate and High Risk Localized Adenocarcinoma of the Prostate.
Study Start Date : March 2013
Estimated Primary Completion Date : September 23, 2019
Estimated Study Completion Date : September 23, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single
Neoadjuvant Androgen Blockade (Casodex) Followed by: Intensity Modulated Radiotherapy (IMRT)2 with Concurrent Androgen Blockade (Casodex and Leuprolide) to Whole Pelvis, Prostate, and Seminal VesiclesFollowed by: Stereotactic Radiosurgical Boost3 to the Prostate with Implanted Electromagnetic Transponder Beacon Intrafraction Guidance Followed by: Adjuvant Androgen Blockade (Casodex)
Radiation: Stereotactic Radiosurgical Boost
Intensity Modulated Radiotherapy (IMRT)2 with Concurrent Androgen Blockade to Whole Pelvis, Prostate, and Seminal Vesicles Followed by: Stereotactic Radiosurgical Boost3 to the Prostate with Implanted Electromagnetic Transponder Beacon Intrafraction Guidance
Other Names:
  • Intensity Modulated Radiotherapy (IMRT)
  • Radiotherapy,
  • X-ray therapy
  • Irradiation

Drug: Casodex
Neoadjuvant Androgen Blockade before radiation therapy and Adjuvant Androgen Blockade after radiation therapy
Other Name: Bicalutamide

Drug: Leuprolide
Neoadjuvant Androgen Blockade before radiation therapy and Adjuvant Androgen Blockade after radiation therapy
Other Name: Goserelin




Primary Outcome Measures :
  1. Tumor Assessment [ Time Frame: 24 months ]
    Tumors will be assessed using the American Joint Committee on Cancer (AJCC) Staging System, 7th Edition. This system consists of the following subscales: the extent of the primary tumor (T category), whether the cancer has spread to nearby lymph nodes (N category), the absence or presence of distant metastasis (M category), the PSA level at the time of diagnosis, and the Gleason score, based on the prostate biopsy (or surgery).


Secondary Outcome Measures :
  1. Zubrod Performance Scale [ Time Frame: Weekly during radiation treatment; every three months during hormone therapy; every six months for 3 yrs after hormone therapy ]
    This is a scale used to evaluate the patient's performance status is an attempt to quantify cancer patients' general well-being and activities of daily life.



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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:

  1. Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate to high risk for recurrence
  2. History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration.
  3. Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MRI), (but not by nodal sampling, or dissection) within 90 days prior to registration.
  4. Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 2.0 cm.
  5. No evidence of bone metastases (M0) on bone scan within 90 days prior to registration.
  6. Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis.
  7. Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 12 weeks (90 days) prior to registration.
  8. Study entry PSA should not be obtained during the following time frames: (1) 10-day period following prostate biopsy; (2) following initiation of hormonal therapy; (3) within 30 days after discontinuation of finasteride; (4) within 90 days after discontinuation of dutasteride.
  9. Zubrod Performance Status 0-2
  10. Complete blood count (CBC)/differential obtained within 2 weeks (14 days) prior to registration on study, with adequate bone marrow function
  11. Patient must be able to provide study specific informed consent prior to study entry.

Exclusion Criteria:

  1. Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 2 years.
  2. Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
  3. Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
  4. Previous hormonal therapy
  5. Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation is ≤ 60 days prior to the date of registration.
  6. Use of finasteride within 30 days prior to registration
  7. Use of dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days prior to registration
  8. Previous or concurrent cytotoxic chemotherapy for prostate cancer; note that prior chemotherapy for a different cancer is allowable. See Section 3.2.1.
  9. Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields
  10. Severe, active co-morbidity including heart issues, infection and liver problems
  11. Patients who are sexually active and not willing/able to use medically acceptable forms of contraception
  12. Prior allergic reaction to the hormones involved in this protocol
  13. Patients status-post a negative lymph node dissection are not eligible

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): NCT02064036


Contacts
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Contact: Heather Melanson 916-734-8628 hcmelanson@ucdavis.edu
Contact: Kristy Lundahl 720-270-9458 krlundahl@ucdavis.edu

Locations
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United States, California
UC Davis Sacramento Cancer Center Dept of Radiation Oncology Recruiting
Sacramento, California, United States, 95817
Contact: Richard Valicenti, MD    916-724-8295    rkvalicenti@ucdavis.edu   
Principal Investigator: Richard Valicenti, MD         
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Richard Valicenti, MD University of California, Davis

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02064036     History of Changes
Other Study ID Numbers: 421870
CCRO025 ( Other Identifier: UC Davis )
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of California, Davis:
Prostate Cancer
Radiotherapy
Androgen Deprivation
Additional relevant MeSH terms:
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Androgens
Androgen Antagonists
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Ascorbic Acid
Methyltestosterone
Leuprolide
Bicalutamide
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