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Trial · Interventional

Active, not recruitingPhase 2Results postedRegistry data

Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer

NCTNCT00544830 (opens ClinicalTrials.gov in a new tab)Other id05190Other idNCI-2010-00425Other id05190Other idP30CA033572

Overview

Status
Active, not recruiting
Phase
Phase 2
Enrollment
29 participants (actual)
Sponsor
City of Hope Medical Center · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
18 Jul 2006
Primary completion
16 Mar 2011
Completion
15 Feb 2027 (estimated)
First posted
16 Oct 2007 (estimated)
Last update posted
15 May 2026
Conditions
PSA Level Greater Than Two · Stage IV Prostate Adenocarcinoma AJCC v7

Timeline

1 trial · 1 ongoing · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201520202025
  1. Ph 2

    Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer

    NCT00544830

    18 Jul 2006 to est. 15 Feb 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This phase II trial studies how well hormone therapy and intensity-modulated radiation therapy work in treating patients with prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Anti-hormone therapy using goserelin, leuprolide acetate, or bicalutamide, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. 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. Giving hormone therapy and intensity-modulated radiation therapy may work better in treating patients with prostate cancer.

Interventions

  • BicalutamideDrug
  • Goserelin AcetateDrug
  • Intensity-Modulated Radiation TherapyRadiation
  • Laboratory Biomarker AnalysisOther
  • Leuprolide AcetateDrug

Arms1

  • Experimental

    Treatment (androgen therapy, radiation therapy)

    ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy. RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time to Prostate-specific Antigen (PSA) Relapse

    Time frame · End-of-therapy until PSA reached pre-treatment level or 10 (whichever was lower)

    Registry description

    Time from the date of the last dose of bicalutamide or the last day of radiation therapy (whichever comes later) until the date criteria are met for PSA relapse. PSA relapse after completion of initial 36 weeks of androgen deprivation therapy is defined as an increase in PSA value to above pre-therapy level, or to \> 10, whichever is smaller. For example, a patient with pre-treatment PSA level of 40 will resume androgen deprivation therapy when PSA level is \> 10, while a patient with pre-treatment PSA level of 3 will resume androgen deprivation therapy when PSA level is \> 3.

Secondary outcomes(6)
  1. Patients Who Achieved PSA Nadir of < 0.2 at 36 Weeks.

    Time frame · During the time period between on-study PSA to off-study PSA, up to 36 weeks.

    Registry description

    Number of Patients who achieved PSA nadir of \< 0.2 at 36 weeks.

  2. Rate of Treatment Failure (no PSA Threshold Below 4 ng/dl, or no PSA Below Baseline Level Before LHRH Treatment).

    Time frame · Off-treatment PSA measurement date minus on-study PSA measurement date, up to 36 weeks.

    Registry description

    Treatment failures: Count and percent of patients NOT reaching PSA concentration in serum either below 4 ng/dl or below baseline before LHRH treatment .

  3. Length of Follow-up

    Time frame · Patients are evaluated for disease on day 1 of each of three 12-week cycles. After the last cycle of anti-androgen therapy, patients are assessed every four weeks until PSA relapse occurs, up to 61.4 months

    Registry description

    Length of follow-up in weeks to off-study date. Patients are treated for 36 weeks (+/- 2 weeks) with androgen deprivation therapy. Patients are evaluated for disease on day 1 of each of three 12-week cycles. After the last cycle of anti-androgen therapy, patients are assessed every four weeks until PSA relapse occurs, up to 264.8 weeks (61.4 months; 5.1 years). Patients will remain off-treatment until they meet the criteria for re-treatment with androgen deprivation therapy, whereupon they will be taken off of the protocol. After patients are taken off protocol, we will do a chart review for long-term outcomes.

  4. Count of Patients Remaining Off of Therapy

    Time frame · after 36 week LHRH treatment window.

    Registry description

    Patients who remained off of therapy, in remission, out of the number of patients with metastases limited to pelvic lymph nodes.

  5. Follow-up of the 8 Patients With Metastases Limited to Pelvic Lymph Nodes.

    Time frame · Patients are followed on day one of each of three 12-week periods. After completion of therapy, patients are followed every four weeks until PSA relapse, up to 46.4 months.

    Registry description

    Length of follow-up of the 8 patients with metastases limited to pelvic lymph nodes, months. Patients are followed on day one of each of three 12-week periods. After completion of therapy, patients are followed every four weeks until PSA relapse, up to 46.4 months.

  6. CR Without ADT in Patients With Metastases Limited to Pelvic Lymph Nodes.

    Time frame · after 36 weeks of LHRH therapy.

    Registry description

    Number of patients remaining in complete remission without androgen deprivation therapy in patients with metastases limited to pelvic lymph nodes.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· End-of-therapy until PSA reached pre-treatment level or 10 (whichever was lower)

Time to Prostate-specific Antigen (PSA) Relapse

GroupValue (month)
Treatment (Androgen Therapy, Radiation Therapy)16.5
Secondary and other outcome results(6)
Secondary outcomeCount of participants· During the time period between on-study PSA to off-study PSA, up to 36 weeks.

Patients Who Achieved PSA Nadir of < 0.2 at 36 Weeks.

GroupValue (Participants)
Treatment (Androgen Therapy, Radiation Therapy)25
Secondary outcomeCount of participants· Off-treatment PSA measurement date minus on-study PSA measurement date, up to 36 weeks.

Rate of Treatment Failure (no PSA Threshold Below 4 ng/dl, or no PSA Below Baseline Level Before LHRH Treatment).

GroupValue (Participants)
Treatment (Androgen Therapy, Radiation Therapy)15
Secondary outcomeMedian· Patients are evaluated for disease on day 1 of each of three 12-week cycles. After the last cycle of anti-androgen therapy, patients are assessed every four weeks until PSA relapse occurs, up to 61.4 months

Length of Follow-up

GroupValue (week)
Treatment (Androgen Therapy, Radiation Therapy)111.4
Secondary outcomeCount of participants· after 36 week LHRH treatment window.

Count of Patients Remaining Off of Therapy

GroupValue (Participants)
Treatment (Androgen Therapy, Radiation Therapy)7
Secondary outcomeMedian· Patients are followed on day one of each of three 12-week periods. After completion of therapy, patients are followed every four weeks until PSA relapse, up to 46.4 months.

Follow-up of the 8 Patients With Metastases Limited to Pelvic Lymph Nodes.

GroupValue (month)
Treatment (Androgen Therapy, Radiation Therapy)14.7
Secondary outcomeCount of participants· after 36 weeks of LHRH therapy.

CR Without ADT in Patients With Metastases Limited to Pelvic Lymph Nodes.

GroupValue (Participants)
Treatment (Androgen Therapy, Radiation Therapy)4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Treatment (Androgen Therapy, Radiation Therapy)ADT: Patients not currently on ADT receive goserelin acetate SC or leuprolide acetate via injection once every 4 or 12 weeks and bicalutamide PO QD. Treatment repeats every 12 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients already receiving ADT at the time of enrollment continue treatment until they have received 36 weeks of therapy. RADIATION THERAPY: Patients achieving PSA normalization after initiation of androgen deprivation therapy undergo intensity-modulated radiation therapy daily for 2-7 weeks during or after completion of androgen deprivation therapy. Bicalutamide: Given PO Goserelin Acetate: Given SC Intensity-Modulated Radiation Therapy: Undergo IMRT Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given via injection–1 / 2928 / 29

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Patients with histologically proven diagnosis of adenocarcinoma of the prostate stage N1, N2, N3, M1a, M1b, M1c with =\< 5 metastatic lesions; if the diagnosis of metastasis in the lymph node is based solely on imaging computed tomography (CT) scan or magnetic resonance imaging (MRI), the longitudinal diameter of the lymph node has to be \>= 2.0 cm; if the lymph node is positive on positron emission tomography (PET) or ProstaScint scan, the longitudinal diameter of the lymph node on CT scan or MRI has to be \>= 1.5 cm * Patients who have measurable disease must have had X-rays, scans or physical examination used for tumor measurement completed within 28 days prior to registration; patients must have non-measurable disease assessed within 42 days prior to registration * Patients must have had documented PSA of \> 2 prior to onset of androgen deprivation * Patients might have received up to 36 weeks of adjuvant androgen deprivation therapy and up to 36 weeks of androgen deprivation therapy for metastatic disease prior to enrollment to this study; patients may be on androgen deprivation for metastatic disease at the time of enrollment to the protocol; adjuvant therapy must have been completed at least 2 years before androgen deprivation for metastatic disease and patients must remain hormone sensitive * Prior radiation therapy for metastatic disease is not allowed * Prior chemotherapy for metastatic disease is not allowed; prior neoadjuvant and adjuvant chemotherapy is allowed; patients must have recovered from all acute side-effects related to previous systemic therapy * Patients are allowed to receive one prior systemic non-chemotherapeutic treatment (i. e. immunotherapy, receptor tyrosine kinase inhibitor, antiangiogenic agent, differentiation agent) for recurrent or metastatic disease; patients must have recovered from all acute side-effects related to previous systemic therapy * Use of bisphosphonates is allowed at the discretion of treating physician * Patients must be capable of understanding the nature of the trial and must give written informed consent * Patients must have a World Health Organization (WHO) performance status of 0, 1, or 2 Exclusion Criteria: * Patients with unstable or severe intercurrent medical conditions or active, uncontrolled infection * Patients with a history of orchiectomy * Patients undergoing therapy with other investigational agents; patients must have recovered from all acute effects of previously administered investigational agents and sufficient time must have elapsed since last administration to ensure the drug interactions not occur during this study * Patients with a history of brain metastases or who currently have treated or untreated brain metastases * Patients who have demonstrated refractoriness to hormone therapy with luteinizing hormone-releasing hormone (LHRH) agonist; refractoriness is defined as occurrence of one of the following while on therapy with LHRH agonist: increase in PSA by 25% over baseline (to at least \> 2 ng/ml) on two consecutive PSA measurements, 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, clear worsening of any non-measurable disease, reappearance of any lesion that had disappeared, appearance of any new lesion

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