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Prostate CancerPhase 3NCT00949962

Post-operative or Early Salvage XRT and ADT for High Risk PCa

A Phase 3 study testing antiandrogen therapy, leuprolide acetate and 3-dimensional conformal radiation therapy in people with Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in France.

Terminated

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

Official record
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Trial summary

RATIONALE: Conformal radiation therapy uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor. Giving conformal external-beam radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Read more about this study

Who is it for?
Ages Up to 80 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
antiandrogen therapy, leuprolide acetate and 3-dimensional conformal radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
1 siteFrance
Study dates
Oct 2009to Jun 2016
Phase
Phase 3
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 Up to 80 years
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of prostate cancer
  • Clinical stage cT1-2-3a, N0, M0 disease pre-operatively
  • Pre-operative PSA ≤ 5 x upper limit of normal
  • Presenting the following conditions after radical prostatectomy:
  • Gleason sum 5-10
  • Pathologic stage pT2R1 (positive surgical margins with at least a tumor trans-section > 2 mm) or pT3a-b (irrespective of margin status)
  • Negative lymph node (LN) status (pN0) by LN sampling or LN dissection
  • Unknown pathological LN status is not allowed, except for disease classified as cT ≤ cT1c with baseline PSA ≤ 10 ng/mL, Gleason score < 7, and ≥ 12 positive core biopsies < 50%
  • Undetectable post-operative PSA within 3 months of surgery

PATIENT CHARACTERISTICS:

  • WHO performance status 0-1
  • WBC ≥ 3 x 10^9/L
  • Hemoglobin ≥ 110 g/L
  • Platelet count ≥ 100 x 10^9/L
  • No other malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient has been disease free for at least 5 years
  • No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 5 years since prior chemotherapy
  • No prior pelvic irradiation
  • No prior bilateral orchiectomy
  • No prior hormonal treatment except neoadjuvant treatment lasting ≤ 3 months
  • No other concurrent anticancer agent or modality

Trial locations and contacts

1 site in 1 country.

France1 site

  • European Organization for Research and Treatment of Cancer

    Grenoble, 38043

Other trials in France

About this study

Official title: Immediate or Early Salvage Post-operative External Radiotherapy Combined With Concomitant and Adjuvant Hormonal Treatment Versus Immediate or Early Salvage Postoperative External Radiotherapy Alone in pT3a-b R0-1 cN0M0 / pT2R1 cN0M0, Gleason Score 5-10 Prostatic Carcinoma. A Phase III Study

RATIONALE: Conformal radiation therapy uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor. Giving conformal external-beam radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Androgens can cause the growth of prostate cancer cells. Hormone therapy, such as leuprolide acetate, may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective when given together with or without hormone therapy in treating patients with prostate cancer who have undergone surgery.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with hormone therapy in treating patients who have undergone surgery for stage I, stage II, or stage III prostate cancer.

Read the detailed description

OBJECTIVES:

  • To investigate the potential benefit of post-operative radiotherapy with vs without a combined and adjuvant treatment consisting of short-term androgen suppression for improving the biochemical progression-free survival of patients who have undergone radical prostatectomy for stage I-III prostate cancer.

OUTLINE: This is a multicenter study. Patients are stratified according to institution, pathological stage (pT2R1 vs pT3R0 vs pT3R1), Gleason sum (≤ 3+4 vs ≥ 4+3), and WHO performance status (0 vs 1). Within 3 months after radical surgery, patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo post-operative conformal external beam irradiation for 6.5 weeks.
  • Arm II: Beginning between days -5 to -3, patients receive an antiandrogen for 2-4 weeks. Beginning on day 0, patients receive leuprolide acetate subcutaneously once (6-month depot) and undergo conformal external beam irradiation 5 times weekly for 6.5 weeks.

Patients undergo quality of life assessments periodically.

After completion of study treatment, patients are followed up every 6 months for 5 years and then yearly thereafter.

Conditions
Prostate Cancer
Being tested
antiandrogen therapy, leuprolide acetate, 3-dimensional conformal radiation therapy
Keywords
stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • antiandrogen therapyDrug

    Given systemically

  • leuprolide acetateDrug

    Given subcutaneously

  • 3-dimensional conformal radiation therapyRadiation

    Undergo radiotherapy

Study groups in NCT00949962
Study groupRoleWhat they receive
Arm IActive comparatorPatients undergo post-operative conformal external beam irradiation for 6.5 weeks.
Receives: Radiation: 3-dimensional conformal radiation therapy
Arm IIExperimentalBeginning on day -5 to -3, patients receive an antiandrogen for 2-4 weeks. Beginning on day 0, patients receive leuprolide acetate subcutaneously once (6-month depot) and undergo conformal external beam irradiation 5 times weekly for 6.5 weeks.
Receives: Drug: antiandrogen therapy; Drug: leuprolide acetate; Radiation: 3-dimensional conformal radiation therapy

What is being measured

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

  1. Biochemical progression-free survival

Secondary outcomes (5)

  1. Clinical progression-free survival

  2. Distant-metastases-free survival

  3. Overall survival

  4. Quality of life as assessed by QLQ-C30 and QLQ-PR25 at baseline and at 6 months, 1 year, 2 years, and 5 years after treatment

  5. Acute and late toxicity according to NCI CTCAE version 3.0

Timeline

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

  1. First posted31 Jul 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionDec 2015 (estimated)
  4. Study completionJun 2016 (estimated)

Why it stopped: Poorly recruiting

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00949962
Sponsor's protocol ID
EORTC-22043-30041
Other IDs
EU-20950, 2006-002772-17
Status last verified
Jul 2014
First submitted
30 Jul 2009
Last updated
4 Jul 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing antiandrogen therapy, leuprolide acetate and 3-dimensional conformal radiation therapy in people with Prostate Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in France.

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

Who may be eligible to take part?

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 4 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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 phase mean?

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?

The study was stopped early (reason given: Poorly recruiting). 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?

Biochemical progression-free survival. 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 NCT00949962.

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 4 Jul 2014.

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