Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Androgen Deprivation Therapy for Metastatic Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00544830
First received: October 13, 2007
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy, such as goserelin, leuprolide, or bicalutamide, may lessen the amount of androgens made by the body. Giving intensity-modulated radiation therapy together with androgen deprivation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well intensity-modulated radiation therapy works in treating patients undergoing androgen deprivation therapy for metastatic prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: bicalutamide
Drug: goserelin
Drug: leuprolide acetate
Radiation: intensity-modulated radiation therapy
Radiation: tomotherapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Androgen Deprivation and Localized Radiotherapy to Metastases in Patients With Oligometastatic Hormone - Sensitive Prostate Cancer

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Time to PSA relapse [ Time Frame: One year from the end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PSA response to treatment [ Time Frame: One year from the end of treatment ] [ Designated as safety issue: No ]
  • Safety as assessed by NCI CTCAE v3.0 [ Time Frame: One year from the end of treatment ] [ Designated as safety issue: Yes ]
  • Feasibility [ Time Frame: One year from the end of treatment ] [ Designated as safety issue: No ]
  • Tolerability as assessed by NCI CTCAE v3.0 [ Time Frame: One year from the end of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 29
Study Start Date: July 2006
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Androgen Deprivation and Radiation Therapy
Androgen deprivation subcutaneously with goserelin or leuprolide, radiation therapy to all known metastatic sites.
Drug: bicalutamide
50 mg orally every day for a total of 36 weeks (+/- 2 weeks)
Drug: goserelin
3.6 mg subcutaneously every 4 weeks or 10.8 mg subcutaneously every 12 weeks for a total of 36 weeks (+/- 2 weeks)
Drug: leuprolide acetate
22.5 mg intramuscularly every 12 weeks for a total of 36 weeks (+/- 2 weeks)
Radiation: intensity-modulated radiation therapy
All sites will be treated using one of the following fractionation schemes: 1) 300 cGy/day to 3000 cGy; 2) 250 cGy/day to 3750 cGy; 3) 200 cGy/day to 4000 cGy.
Radiation: tomotherapy
All sites will be treated using one of the following fractionation schemes: 1) 300 cGy/day to 3000 cGy; 2) 250 cGy/day to 3750 cGy; 3) 200 cGy/day to 4000 cGy.

Detailed Description:

OBJECTIVES:

  • To evaluate the time to PSA relapse in patients with oligometastatic (i.e., ≤ 5 lesions) hormone-sensitive prostate cancer treated with 36 weeks of androgen deprivation therapy and localized radiotherapy to all known tumor sites.
  • To assess the PSA and objective tumor response rate in patients treated with this regimen.
  • To assess the toxicity of this regimen in these patients.
  • To evaluate the feasibility and toxicities of using helical tomotherapy image-guided intensity-modulated radiotherapy to treat oligometastatic sites in these patients.

OUTLINE: Patients are stratified according to androgen-deprivation therapy status at time of study entry (currently receiving or planning to receive vs completed or almost completed).

Patients who are not currently androgen deprivation therapy at the time of enrollment receive 36 weeks of androgen deprivation therapy comprising goserelin subcutaneously or leuprolide acetate intramuscularly once every 4-12 weeks and oral bicalutamide once daily for 36 weeks. Patients who are already receiving androgen deprivation therapy at the time of enrollment will continue treatment until they have received a total of 36 weeks of therapy.

All patients undergo helical tomotherapy image-guided intensity-modulated radiotherapy beginning at the time they achieve PSA normalization (i.e., stable or declining PSA level ≤ 4 ng/mL or stable or declining PSA level ≤ pretreatment level, whichever is smaller) on two consecutive measurements taken after androgen deprivation therapy is initiated. All known metastatic sites are irradiated for 2-7 weeks during or after completion of androgen deprivation therapy.

Patients remain off treatment until PSA relapse, defined as an increase in the PSA level to the pre-androgen deprivation therapy level or > 10 ng/mL, whichever is smaller. Once the patient meets the criteria for re-treatment with androgen deprivation therapy, they are removed from study.

After completion of study therapy, patients are followed periodically.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Stage N1, N2, N3, M1a, M1b, M1c disease with ≤ 5 metastatic lesions

      • If the diagnosis of metastasis is based solely on imaging CT scan or MRI, the longitudinal diameter of the lymph node (LN) must be ≥ 2.0 cm
      • If the LN is positive on PET or Prostascint scan, the longitudinal diameter of the LN must be ≥ 1.5 cm on CT scan or MRI
  • Measurable disease documented by x-rays, scans, or physical examination within the past 28 days OR nonmeasurable disease assessed within the past 42 days
  • Has received up to 36 weeks of adjuvant androgen deprivation therapy for metastatic disease OR is planning to receive 36 weeks of adjuvant androgen deprivation therapy

    • Patients who are not receiving androgen deprivation therapy at the time of enrollment undergo androgen deprivation therapy
    • Patients who are already receiving androgen deprivation therapy at the time of enrollment will continue treatment, as described above, until they have received a total of 36 weeks of treatment
    • Patients who have enrolled on study after completion of androgen deprivation therapy or near the end of their treatment course must have serum testosterone level at castrate levels (< 50 ng/dL)
  • Documented PSA level > 2 ng/mL prior to onset of androgen deprivation
  • No disease that is refractory to hormone therapy, as demonstrated by occurrence of 1 of the following while on luteinizing hormone-releasing agonist therapy:

    • Increase in PSA by 25% over baseline to at least > 2 ng/mL on two consecutive PSA measurements
    • Increase by 20% in the sum of longest diameters of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as were used at baseline
    • Clear worsening of any nonmeasurable disease
    • Reappearance of any lesion that had disappeared
    • Appearance of any new lesion
  • No history of brain metastases or current treated or untreated brain metastases

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Able to understand the nature of the trial
  • No unstable or severe concurrent medical conditions
  • No active uncontrolled infection

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior systemic therapy and other previously administered investigational agents
  • No prior radiotherapy or chemotherapy for metastatic disease

    • Prior neoadjuvant and adjuvant chemotherapy allowed
  • May have received one prior systemic non-chemotherapeutic treatment (i.e., immunotherapy, receptor tyrosine kinase inhibitor, antiangiogenic agent, or differentiating agent) for recurrent or metastatic disease
  • More than 2 years since prior adjuvant therapy before androgen deprivation therapy for metastatic disease AND patient must remain hormone-sensitive
  • Sufficient time must have elapsed since other prior investigational agents to ensure that drug interactions do not occur during this study
  • No history of orchiectomy
  • Concurrent androgen deprivation therapy for metastatic disease allowed
  • Concurrent bisphosphonates allowed at the discretion of the treating physician
  • No other concurrent investigational agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544830

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
City of Hope Medical Group
Pasadena, California, United States, 91105
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Przemyslaw W. Twardowski, MD Beckman Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00544830     History of Changes
Other Study ID Numbers: 05190, P30CA033572, CHNMC-05190, CDR0000570276
Study First Received: October 13, 2007
Last Updated: January 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
stage IV prostate cancer
adenocarcinoma of the prostate
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Leuprolide
Goserelin
Bicalutamide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on July 31, 2014