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Prostate Cancer Stage IIIPhase 2QRT-SOGUGNCT03432780

Radiation-hormone and Docetaxel VS Radiation-hormone in Patients With High-Risk Localized Prostate Cancer

A Phase 2 study testing Docetaxel, Hormone and radiation therapy and Radiation therapy in people with Prostate Cancer Stage III and Prostate Cancer Stage IV, run by Spanish Oncology Genito-Urinary Group.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A prospective, multicenter, parallel-group, open-label, randomized, phase II Clinical Study of Radiation Therapy, Hormone Therapy and Docetaxel Versus Radiation Therapy and Hormone Therapy in Patients with High-Risk Localized Prostate Cancer (Stage III and IV) whose primary objective is determine the percentage of… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Docetaxel, Hormone and radiation therapy and Radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
No sites listed yet
Study dates
18 Dec 2008to 14 Nov 2023
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological confirmation of adenocarcinoma of the prostate.
  • Age > 18 years.
  • Localized high-risk prostate cancer, defined as:
  • Stage III: T3 N0 M0, Gleason grade 8, 9, or 10, or
  • Stage IV: T4 N0 M0, any Gleason grade or Tx N1 M0, any Gleason grade
  • PSA > 20 ng/mL.
Show all 11Show fewer
  • Karnofsky index ≥ 70%
  • Good bone marrow reserve, with white blood cell count > 3000/mm3, hemoglobin >9.5 g/dL and platelets > 150,000/mm3.
  • Absence of hepatic abnormality, with bilirubin values < 1.5 mg/dL and with SGOT/SGPT values up to 2 times the upper limit of normality for each site.
  • Absence of abnormality in renal function, with creatinine levels up to 2 times the upper limit of normality for each site.
  • Having given informed consent in writing.

Who cannot join

  • Previous hormone treatment during more than 3 months.
  • Previous surgical treatment, pelvic radiation therapy, or chemotherapy for the current illness.
  • Concomitant second neoplasm or history of neoplastic disease in the last 5 years, except for cutaneous basal cell carcinoma.
  • Metabolic disease or uncontrolled systemic disease.
  • Previous history of grade III-IV neuropathy (NCI CTCAE v3).
  • Psychological, social, family, or geographical conditions that may compromise compliance with or follow-up of the study.
  • Having received treatment with an investigational medicinal product during the 30 days prior to inclusion in the study.
  • Inflammatory bowel disease.

About this study

Official title: Randomized Phase II Clinical Study of Radiation Therapy, Hormone Therapy and Chemotherapy With Docetaxel Versus Radiation Therapy and Hormone Therapy in Patients With High-Risk Localized Prostate Cancer (Stage III and IV)"

A prospective, multicenter, parallel-group, open-label, randomized, phase II Clinical Study of Radiation Therapy, Hormone Therapy and Docetaxel Versus Radiation Therapy and Hormone Therapy in Patients with High-Risk Localized Prostate Cancer (Stage III and IV) whose primary objective is determine the percentage of patients free of biochemical recurrence within 5 years of receiving a combination of radiation therapy with docetaxel associated with hormone therapy or the standard of care of radiation therapy and hormone therapy in patients with stage III and IV localized prostate cancer with a poor prognosis.

Read the detailed description

Randomized Phase II Clinical Study of Radiation Therapy, Hormone Therapy and Chemotherapy with Docetaxel Versus Radiation Therapy and Hormone Therapy in Patients with High-Risk Localized Prostate Cancer (Stage III and IV) Primary Objective: To determine the percentage of patients free of biochemical recurrence within 5 years of receiving a combination of radiation therapy with docetaxel associated with hormone therapy or the standard of care of radiation therapy and hormone therapy in patients with stage III and IV localized prostate cancer with a poor prognosis.

Design: A prospective, multicenter, multidisciplinary, parallel-group, open-label study with randomized group assignment.

Being tested
Docetaxel, Hormone and radiation therapy, Radiation therapy
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • DocetaxelDrug

    Also called Taxotere

  • Hormone and radiation therapyBiological

  • Radiation therapyRadiation

Study groups in NCT03432780
Study groupRoleWhat they receive
Docetaxel, hormone and radiation therapyExperimentalRadiation therapy combined with weekly docetaxel (20 mg/m2) and hormone therapy.
Receives: Drug: Docetaxel; Biological: Hormone and radiation therapy; Radiation: Radiation therapy
Hormone and radiation therapyActive comparatorRadiation therapy and hormone therapy
Receives: Biological: Hormone and radiation therapy; Radiation: Radiation therapy

What is being measured

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

  1. Percentage of patients free of biochemical recurrence within 5 years of receiving a combination of radiation therapy with docetaxel associated with hormone therapy or the standard of care of radiation therapy and hormone therapy

    Percentage of patients free of elevation of PSA by 2 ng/mL above the minimum level reached since treatment (biochemical reccurrence), calculating the at-call event, i.e., the date of last confirmatory test (Phoenix criteria).

    Measured: 5 years of randomization

Secondary outcomes (7)

  1. Percentage of patients with biochemical recurrence-free survival

    The duration of survival, in months, between randomization of the patient in the study and the date of recurrence by PSA. In the remaining patients, the last available follow-up will be taken as the last control

    Measured: 5 years

  2. Percentage of patients with progression-free survival

    The duration of survival, in months, between randomization of the patient in the study and the date of recurrence by PSA, clinical manifestations or death due to disease. In the remaining patients, the last available follow-up will be taken as the last control

    Measured: 5 years

  3. Percentage of patients with overall survival.

    Defined as the time that elapses, in months, between randomization of the patient in the study and the date of death, regardless of the cause. In the remaining patients, the last available follow-up will be taken as the last control.

    Measured: 5 years

  4. Clinical response rate

    The clinical response rate: percentage of patients with partial and complete response, according to RECIST criteria.

    Measured: 5 years

  5. Biochemical response rate.

    Biochemical response rate: percentage of patients with partial and complete response, according to PSA levels.

    Measured: 5 years

  6. Quality of life of the patients

    Change from baseline in the Quality of Life Questionnaire C30 scale (QLQ-C30) to week 9. The QLQ-c30 has five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. They are assigned values between 1 and 4 (1: nothing, 2: a few, 3: enough, 4: a lot) according to the patient's responses to the item, only in items 29 and 30 are assessed with a score from 1 to 7 (1: terrible, 7: excellent). The obtained scores are summed and standardized and gets a score between 0 and 100

    Measured: screening and week 9

  7. Safety profile of the treatment.

    Numbers of events evaluated according to NCI criteria CTCAE v3

    Measured: 5 years

Timeline

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

  1. First posted14 Feb 2018
  2. Study start18 Dec 2008
  3. Primary completion14 Nov 2023 (estimated)
  4. Study completion14 Nov 2023 (estimated)

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
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
A prospective, multicenter, multidisciplinary, parallel-group, open-label study with randomized group assignment
Masking
None (open label)
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03432780
Sponsor's protocol ID
QRT-SOGUG
Other IDs
2008-003554-14, 2008
Acronym
QRT-SOGUG
Status last verified
Jan 2021
First submitted
15 Jan 2018
Last updated
22 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Armstrong CM, Gao AC. Drug resistance in castration resistant prostate cancer: resistance mechanisms and emerging treatment strategies. Am J Clin Exp Urol. 2015 Aug 8;3(2):64-76. eCollection 2015.

    PubMed 26309896

  • Bolla M, Collette L, Blank L, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Mattelaer J, Lopez Torecilla J, Pfeffer JR, Lino Cutajar C, Zurlo A, Pierart M. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet. 2002 Jul 13;360(9327):103-6. doi: 10.1016/s0140-6736(02)09408-4.

    PubMed 12126818

  • Lawton CA, Winter K, Byhardt R, Sause WT, Hanks GE, Russell AH, Rotman M, Porter A, McGowan DG, DelRowe JD, Pilepich MV. Androgen suppression plus radiation versus radiation alone for patients with D1 (pN+) adenocarcinoma of the prostate (results based on a national prospective randomized trial, RTOG 85-31). Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys. 1997 Jul 15;38(5):931-9. doi: 10.1016/s0360-3016(97)00288-5.

    PubMed 9276357

  • Kumar P, Perrotti M, Weiss R, Todd M, Goodin S, Cummings K, DiPaola RS. Phase I trial of weekly docetaxel with concurrent three-dimensional conformal radiation therapy in the treatment of unfavorable localized adenocarcinoma of the prostate. J Clin Oncol. 2004 May 15;22(10):1909-15. doi: 10.1200/JCO.2004.02.001.

    PubMed 15143084

  • Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. doi: 10.1056/NEJMoa040720.

    PubMed 15470213

  • Petrylak DP, Tangen CM, Hussain MH, Lara PN Jr, Jones JA, Taplin ME, Burch PA, Berry D, Moinpour C, Kohli M, Benson MC, Small EJ, Raghavan D, Crawford ED. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1513-20. doi: 10.1056/NEJMoa041318.

    PubMed 15470214

  • Hennequin C, Giocanti N, Favaudon V. Interaction of ionizing radiation with paclitaxel (Taxol) and docetaxel (Taxotere) in HeLa and SQ20B cells. Cancer Res. 1996 Apr 15;56(8):1842-50.

    PubMed 8620502

  • Mason KA, Hunter NR, Milas M, Abbruzzese JL, Milas L. Docetaxel enhances tumor radioresponse in vivo. Clin Cancer Res. 1997 Dec;3(12 Pt 1):2431-8.

    PubMed 9815644

  • Kumar P. A new paradigm for the treatment of high-risk prostate cancer: radiosensitization with docetaxel. Rev Urol. 2003;5 Suppl 3(Suppl 3):S71-7.

    PubMed 16985954

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, Hormone and radiation therapy and Radiation therapy in people with Prostate Cancer Stage III and Prostate Cancer Stage IV, run by Spanish Oncology Genito-Urinary Group.

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 11 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

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 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.

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

Are results available for this study?

Results are not available in the source record.

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?

Percentage of patients free of biochemical recurrence within 5 years of receiving a combination of radiation therapy with docetaxel associated with hormone therapy or the standard of care of radiation therapy and hormone therapy (time frame: 5 years of randomization). 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 NCT03432780, which also lists 9 linked publications.

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 22 Jan 2021.

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