Clinical Trials /

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

NCT02064036

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Stereotactic Boost and Long-Term Androgen Deprivation for Adenocarcinoma of the Prostate
  • 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.

Clinical Trial IDs

  • ORG STUDY ID: 421870
  • SECONDARY ID: CCRO025
  • NCT ID: NCT02064036

Conditions

  • Adenocarcinoma of the Prostate

Interventions

DrugSynonymsArms
CasodexBicalutamideSingle
LeuprolideGoserelinSingle

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
SingleExperimentalNeoadjuvant 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)
  • Casodex
  • Leuprolide

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Tumor Assessment
Time Frame:24 months
Safety Issue:
Description: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

Measure:Zubrod Performance Scale
Time Frame:Weekly during radiation treatment; every three months during hormone therapy; every six months for 3 yrs after hormone therapy
Safety Issue:
Description: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.

Details

Phase:N/A
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of California, Davis

Trial Keywords

  • Prostate Cancer
  • Radiotherapy
  • Androgen Deprivation

Last Updated

December 18, 2018