AzTrials
AzTrials

Prostate CancerPhase 2/3NCT01603420

External Beam Radiation With or Without Chemotherapy to Treat High Risk Prostate Cancer

A Phase 2/3 study testing Luteinizing hormone-releasing hormone (LHRH), Docetaxel and Conformal Radiation Therapy (RT) in people with Prostate Cancer, run by Proton Collaborative Group at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this study is to compare the effects on prostate cancer using radiation therapy with or without chemotherapy. Read more about this study

Who is it for?
Ages 18 to 75 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Luteinizing hormone-releasing hormone (LHRH), Docetaxel and Conformal Radiation Therapy (RT)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
3 sitesUnited States
Study dates
Jul 2012to May 2014
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed prostate adenocarcinoma (within 365 days of randomization.
  • High-risk for recurrence as determined by evidence of at least one of the following: Gleason score 8-10, PSA > 20, T state T3.
  • Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material: Gleason score must be in the range 2-10. > 6 cores are strongly recommended.
  • Clinical stages T1a- T3 N0 M0 as staged by the treating investigator. (AJCC Criteria 7th Ed.-appendix III).
  • PSA values < = 50 ng/ml within 90 days prior to randomization. Must be completed prior to biopsy or at least 21 days after prostate biopsy.
  • Absolute Neutrophil Count (ANC) > = 1,800 cells/mm³ within 90 days prior to randomization.
Show all 16Show fewer
  • Platelets > = 100,000 cells/mm³ within 90 days prior to randomization.
  • Hemoglobin > 10 g/dl within 90 days prior to randomization.
  • ALT, AST, and total bilirubin within 1.5 X institutional upper normal limits within 90 days prior to randomization.
  • ECOG status 0-1 (appendix II) documented within 90 days of randomization.
  • Patient must sign study specific informed consent prior to randomization. Note: consent for legally authorized representative is not permitted.
  • Completed all requirements listed in section 4.0 within the specified time frames.
  • Able to start treatment within 56 days of randomization.
  • At least 18 years old and less than or equal to 75 years of age.
  • Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards.
  • Medical oncology consultation prior to randomization and medically approved for chemotherapy treatment per protocol.

Who cannot join

  • Evidence of distant metastasis.
  • Pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
  • Prior prostate cancer surgery including but not limited to prostatectomy, hyperthermia and cryosurgery.
  • Prior pelvic radiation for their prostate cancer.
  • Prior androgen deprivation.
  • Severe, active co-morbidity, defined as follows:
Show all 17Show fewer
  • Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis. (Non-active diverticulitis and Crohn's disease not affecting the rectum are allowed).
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months.
  • Myocardial infarction within the last 6 months.
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of randomization.
  • Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
  • Prior allergic reaction to the drugs involved in this protocol.
  • Existing peripheral neuropathy > = grade 2.
  • Prior systemic chemotherapy for prostate cancer.
  • History of proximal urethral stricture requiring dilatation.
  • Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up.
  • Evidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed.)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Hampton University Proton Therapy Institute

    Hampton, Virginia, 23666

  • Procure Proton Therapy Center

    Oklahoma City, Oklahoma, 73142

  • CDH Proton Center

    Warrenville, Illinois, 60555

Other trials in United States

About this study

Official title: Phase 2/3 Study of Dose-escalated External Beam Radiation Therapy With or Without Chemotherapy for High Risk Adenocarcinoma of the Prostate

The purpose of this study is to compare the effects on prostate cancer using radiation therapy with or without chemotherapy.

Read the detailed description

The recommended treatment for a high risk prostate cancer consists of a combination of radiation therapy and androgen suppression for 2-3 years. Recent studies have shown a survival advantage for chemotherapy for prostate cancer. Chemotherapy has already been successfully integrated in the treatment of other cancer types and is our belief that chemotherapy will prove to be beneficial for patients with high risk prostate cancer. However, a clinical study is necessary to compare the results good or bad of chemotherapy with radiation therapy.

Conditions
Prostate Cancer
Being tested
Luteinizing hormone-releasing hormone (LHRH), Docetaxel, Conformal Radiation Therapy (RT)
Keywords
prostate, cancer, radiation, proton, chemotherapy, high risk
Medical subject headings
Prostatic Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Luteinizing hormone-releasing hormone (LHRH)Drug

    Also called -Androgen Suppression, -Androgen Deprivation, -Zoladex, -Lupron

    Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.

  • DocetaxelDrug

    Also called -taxotere, -docetaxel

    Docetaxel 20mg/m2 IV every 7 days x 8 weeks.

  • Conformal Radiation Therapy (RT)Other

    Also called Intensity-modulated Radiation Therapy (IMRT), Proton Therapy, Particle Therapy

    1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).

Study groups in NCT01603420
Study groupRoleWhat they receive
Radiation + 24mo luteinizing hormone-releasing hormone (LHRH)Active comparatorConformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).
Receives: Drug: Luteinizing hormone-releasing hormone (LHRH); Other: Conformal Radiation Therapy (RT)
Radiation + Chemo + 6mo luteinizing hormone-releasing hormoneExperimentalConformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).
Receives: Drug: Luteinizing hormone-releasing hormone (LHRH); Drug: Docetaxel; Other: Conformal Radiation Therapy (RT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 2 - Assessment of Number of Freedom From Failure Events in the Chemotherapy Arm

    Measurement of Freedom from Failure i.e. the first occurence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (Prostate Specific Antigen [PSA] > = 2 ng/ml over the nadir PSA discounting bounces per the investigators discretion), or the start of salvage therapy including androgen deprivation.

    This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months).

    Measured: No failures were reported at the time of study termination (22 months). This outcome was originally written to assess failure at 2 years. However, that end point was not reached.

  2. Phase 2 - Assessment of Number of Freedom From Failure Event Comparing Chemotherapy Arm to Standard Treatment Arm

    This endpoint will be examined if decision is made to not move forward with phase 3 study.

    This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed.

    Measured: at 5 years

  3. Phase 2 - Cumulative Number of Incidences of Grade 3 or Higher Adverse Events.

    Assessment will be performed using CTCAE v4 criteria.

    This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months).

    Measured: 2 years

  4. Phase 3 - Assessment of the Number of Freedom From Failure (FFF) Events Comparing the Chemotherapy Arm to the Standard Treatment Arm.

    The events for FFF will be the first occurence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA > = ng/ml over the nadir PSA discounting bounces per the investigators discretion), or the start of salvage androgen deprivation.

    This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed.

    Measured: at 5 years

Secondary outcomes (8)

  1. Assessment of Number of Grade 2 or Higher Genitourinary (GU) and Gastrointestinal (GI) Adverse Events

    Assessment will be performed using CTCAE v 4 criteria.

    Measured: at 6 months

  2. Assessment of Number of GI and GU Adverse Events

    Descriptive measurements of frequency will be compiled.

    This study was terminated prior to the time frame of 3 years being reached. Therefore, this outcome was not assessed. Data were collected on toxicities up until study closure at 22 months. However, this timepoint was not indicated as a secondary objective in the protocol. Therefore, data was not analyzed at time of study closure.

    Measured: at 3 years

  3. Assessment of Total Number of Local/Distant Failures

    The total number of local/distant failures will be assessed.

    Measured: at time of study closure (22 months)

  4. Assessment of Impotence by Summation of Relative Scores for Sexual Function From the EPIC Quality of Life Instrument.

    unable to assess due to lack of data

    Measured: Up to 10 years

  5. Assessment of Total Number of Salvage Androgen Deprivation Use With Comparison of Arms.

    The total number of subjects with salvage androgen deprivation use will be assessed.

    Measured: At study closure (22 months)

  6. Assessment of Total Number of Survival Events With Comparison of Group Arms

    The number of deaths in both arms will be assessed.

    Measured: at study closure (22 months)

  7. Assessment of Total Number of Biochemical Failure Events

    The number of biochemical failure events will be assessed on both arms.

    Measured: at study closure (22 months)

  8. Assessment of Quality of Life - Summation of Relative Scores From the EPIC Instrument.

    unable to assess due to lack of data

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionMay 2014
  4. Study completionMay 2014

Why it stopped: enrollment goals not met

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01603420
Sponsor's protocol ID
GU004-11
Status last verified
Feb 2016
First submitted
18 May 2012
Last updated
14 Mar 2016
Data monitoring committee
Yes

Publications

  • Guttilla A, Bortolus R, Giannarini G, Ghadjar P, Zattoni F, Gnech M, Palumbo V, Valent F, Garbeglio A, Zattoni F. Multimodal treatment for high-risk prostate cancer with high-dose intensity-modulated radiation therapy preceded or not by radical prostatectomy, concurrent intensified-dose docetaxel and long-term androgen deprivation therapy: results of a prospective phase II trial. Radiat Oncol. 2014 Jan 14;9:24. doi: 10.1186/1748-717X-9-24.

    PubMed 24423462

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Luteinizing hormone-releasing hormone (LHRH), Docetaxel and Conformal Radiation Therapy (RT) in people with Prostate Cancer, run by Proton Collaborative Group at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 2 - Assessment of Number of Freedom From Failure Events in the Chemotherapy Arm (time frame: No failures were reported at the time of study termination (22 months). This outcome was originally written to assess failure at 2 years. However, that end point was not reached.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01603420, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in