Prostate CancerPhase 3NCT02091661
Radical Retropubic Prostatectomy Versus Conventional External Beam Radiotherapy for Clinically Localized Prostate Cancer
A Phase 3 study testing Radical retropubic prostatectomy and External beam radiotherapy in people with Prostate Cancer, run by University of Rome Tor Vergata.
Trial summary
The purpose of this study is to evaluate the effectiveness of the two most established primary treatments for patients with clinically localized prostate cancer: radical retropubic prostatectomy, and external-beam radiotherapy. Read more about this study
- Who is it for?
- Ages Up to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radical retropubic prostatectomy and External beam radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jan 1997to 24 Mar 2020
- 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 75 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 75 years or younger
- Diagnosis of prostate cancer, as verified by cytologic or histologic examination the tumor is well differentiated to moderately well differentiated
- Untreated, clinically localized prostate cancer, with a tumor stage of T1, or T2
- Prostate specific antigen (PSA) level of ≤10 ng/ml
- Bone scan with no abnormalities
- Health status that would permit radical prostatectomy
- Life expectancy of more than 10 years.
Who cannot join
- PSA >10 ng/ml
- Bone scan consistent with metastatic disease
- Other evidence that cancer of the prostate is not clinically localized
- Life expectancy less than 10 years
- Serum creatinine greater than 3 mg/dl
- Myocardial infarction within last 6 months
Show all 11Show fewer
- Unstable angina Class III or IV
- Severe pulmonary disease
- Liver failure
- Severe dementia
- Debilitating illness Malignancies, except for nonmelanomatous skin cancer, in the last 5 years.
About this study
The purpose of this study is to evaluate the effectiveness of the two most established primary treatments for patients with clinically localized prostate cancer: radical retropubic prostatectomy, and external-beam radiotherapy. The primary aim is assessing biochemical disease-free survival, overall survival, and prostate cancer-specific survival. As secondary objectives quality of Life impact of treatments' side effects will be also assessed.
Read the detailed description
Eligible patients had clinically localized (clinical TNM classification T1 or T2), biopsy-proven adenocarcinoma of the prostate and were randomly treated with RRP or EBRT. Exclusion criteria included prior treatment for prostate cancer, the presence of metastatic disease on imaging studies, the receipt of neoadjuvant androgen ablation before registration, and an inability to read or understand Italian language. The institutional review boards of every participating centre approved the study design. Every patient enrolled signed an informed-consent form approved by the institutional review boards. Clinical information collected from the medical record included pre-treatment serum prostate-specific antigen (PSA) level, clinical T classification, and biopsy Gleason score. Follow-up assessments were completed before treatment and every 3 months after treatment. Subjects who sought primary treatment elsewhere or did not return follow-up questionnaires beyond the initial assessment were excluded from this analysis.
- Conditions
- Prostate Cancer
- Being tested
- Radical retropubic prostatectomy, External beam radiotherapy
- Keywords
- Clinically localized prostate cancer, Radical retropubic prostatectomy, External beam radiotherapy, Efficacy, Quality of life, adverse events
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical retropubic prostatectomyProcedure or surgery
The surgery arm underwent radical retropubic prostatectomy, performed by a technique described by Walsh. The prostatectomy is performed in retrograde way, preserving the neurovascular bundles if feasible. The degree to which the surgeon preserve the nerves is categorized as non-nerve-sparing, unilateral nerve-sparing, or bilateral nerve-sparing. Pelvic lymph node dissection is performed if feasible. The operative time is about 2 to 3 hours and required hospital stay. The patient has a urinary catheter placed for 6 to 9 days to facilitate bladder emptying.
External beam radiotherapyRadiation
External beam radiotherapy is carried out with intensity-modulated radiation technique. The treatment is designed to maximize the radiation dose to the prostate and seminal vesicles and minimize exposure to surrounding structures, including the bladder and rectum. Radiation to the prostate was delivered in fractionated doses divided over multiple treatments (180 to 200 centigray (cGy) daily fractions, 5 days per week) for a total dose to the prostate of 68 to 77 gray (Gy), prescribed at 90% to 100% of the isodose line.
| Study group | Role | What they receive |
|---|---|---|
| Radical retropubic prostatectomy | Active comparator | The surgery arm underwent radical retropubic prostatectomy, performed by a technique described by Walsh.surgery started with dissection of the pelvic lymph nodes. If there were no signs of metastasis in frozen sections, the operation was continued with retropubic radical prostatectomy. The prostatectomy is performed in retrograde way, preserving the neurovascular bundles if feasible. The degree to which the surgeon preserve the nerves is categorized as non-nerve-sparing, unilateral nerve-sparing, or bilateral nerve-sparing.The operative time is about 2 to 3 hours and required hospital stay. The patient has a urinary catheter placed for 6 to 9 days to facilitate bladder emptying. Receives: Procedure: Radical retropubic prostatectomy |
| External beam radiotherapy | Active comparator | External beam radiotherapy is carried out with intensity-modulated radiation technique. The treatment is designed to maximize the radiation dose to the prostate and seminal vesicles and minimize exposure to surrounding structures, including the bladder and rectum. Radiation to the prostate was delivered in fractionated doses divided over multiple treatments (180 to 200 centigray (cGy) daily fractions, 5 days per week) for a total dose to the prostate of 68 to 77 gray (Gy), prescribed at 90% to 100% of the isodose line. Receives: Radiation: External beam radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical disease-free survival
Number of participants who are free of biochemical relapse after a specified duration of time. Biochemical recurrence is measured by PSA levels. The definition of biochemical recurrence was based on a review of the literature and consideration of clinical practice in the year 1997. Biochemical recurrence among patients who underwent radical prostatectomy (RP) was defined as a measurable serum PSA concentration 0.2 ng/ml or greater. The American Society for Therapeutic Radiology and Oncology (ASTRO) criteria were used to define progression after radiation therapy. The ASTRO consensus definition specifies progression as 3 consecutive increases in serum PSA documented at intervals of 6 or more months.
Measured: up to 12 months
Secondary outcomes (6)
•Perceived general health measured by the Medical Outcomes Study 36-Item Short Form (SF-36).
The Medical Outcomes Study 36-Item Short Form (SF-36) version 2 contains 36 items covering eight dimensions: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and mental health. For each dimension, a score ranges from 0-100 (higher score indicate better health).Physical and mental component summaries are constructed, using recommended scoring algorithms. Summary scores are standardized to have a mean of 50 and standard deviation of 10 in the general population.
Measured: 1, 3, 6, 12 and 24 months after treatment.
•Cancer specific Quality of Life measured by the Functional Assessment of Cancer Therapy - General and Prostate specific - (FACT-G and FACT-P, respectively).
The Functional Assessment of Cancer Therapy - General (FACT-G) version 4.0 was designed to measure Quality of Life in cancer patients. It consists of 27 items in 4 dimensions measuring Physical, Social/familial, Emotional, and Functional well-being. The Prostate module (FACT-P) is specific for patients with prostate cancer and contains 12 questions about urinary symptoms, and bowel and sexual function. Scores range from 0 to 108 on the FACT-G, and from 0 to 48 on the FACT-P, with 0 representing perfect health.
Measured: 1, 3, 6, 12 and 24 months after treatment.
•Urinary symptoms measured by the International Prostate Symptom Score (IPSS).
The International Prostate Symptom Score (IPSS) was developed to assess the severity of lower urinary tract symptoms associated to Benign Prostatic Hyperplasia and has also been applied to other conditions that cause lower urinary tract symptoms (LUTS). The IPSS consists of a total of seven questions that deal with voiding symptoms (incomplete empty, intermittency, weak stream and straining to void) and storage symptoms (frequency, urgency and nocturia) and an additional question to measure quality of life. The score ranges from 0 to 35, with lower scores denoting a better health state.
Measured: 1, 3, 6, 12 and 24 months after treatment.
•Sexual symptoms measured by the International Index of Erectile Function (IIES).
The International Index of Erectile Function (IIES) is a 15-item, self-administered questionnaire scale for the assessment of erectile function. Scores range from 5 to 75, with higher scores denoting a better sexual function.
Measured: 1, 3, 6, 12 and 24 months after treatment.
Overall survival.
Number of participants who are alive after a specified duration of time.
Measured: 5, 7 and 10 years after treatment and every 5 years thereafter.
Prostate cancer-specific survival
Number of participants who are not dead due to prostate cancer after a specified duration of time
Measured: 3, 5, and 10 years after treatment and then every 5 years thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startJan 1997
- Primary completionSep 2001
- Study completion24 Mar 2020 (estimated)
Why it stopped: accrual too slow
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savino M. Di Stasi, University of Rome Tor Vergata
- Investigators
- Savino M. Di Stasi, MD, PhD, Study chair, Tor Vergata University of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091661
- Sponsor's protocol ID
- UTV55/96
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2014
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radical Retropubic Prostatectomy Versus Conventional External Beam Radiotherapy for Clinically Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT02091661
- Acronym / sponsor ID
- UTV55/96
- Conditions
- Prostate Cancer
- Keywords
- Clinically localized prostate cancer, Radical retropubic prostatectomy, External beam radiotherapy, Efficacy, Quality of life, adverse events
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: accrual too slow
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- Jan 1997
- Primary completion
- Sep 2001 (actual)
- Study completion
- 24 Mar 2020 (estimated)
- First posted
- 19 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of the two most established primary treatments for patients with clinically localized prostate cancer: radical retropubic prostatectomy, and external-beam radiotherapy. The primary aim is assessing biochemical disease-free survival, overall survival, and prostate cancer-specific survival. As secondary objectives quality of Life impact of treatments' side effects will be also assessed.
Detailed description
Eligible patients had clinically localized (clinical TNM classification T1 or T2), biopsy-proven adenocarcinoma of the prostate and were randomly treated with RRP or EBRT. Exclusion criteria included prior treatment for prostate cancer, the presence of metastatic disease on imaging studies, the receipt of neoadjuvant androgen ablation before registration, and an inability to read or understand Italian language. The institutional review boards of every participating centre approved the study design. Every patient enrolled signed an informed-consent form approved by the institutional review boards. Clinical information collected from the medical record included pre-treatment serum prostate-specific antigen (PSA) level, clinical T classification, and biopsy Gleason score. Follow-up assessments were completed before treatment and every 3 months after treatment. Subjects who sought primary treatment elsewhere or did not return follow-up questionnaires beyond the initial assessment were excluded from this analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radical retropubic prostatectomy | Active comparator | Procedure: Radical retropubic prostatectomyThe surgery arm underwent radical retropubic prostatectomy, performed by a technique described by Walsh.surgery started with dissection of the pelvic lymph nodes. If there were no signs of metastasis in frozen sections, the operation was continued with retropubic radical prostatectomy. The prostatectomy is performed in retrograde way, preserving the neurovascular bundles if feasible. The degree to which the surgeon preserve the nerves is categorized as non-nerve-sparing, unilateral nerve-sparing, or bilateral nerve-sparing.The operative time is about 2 to 3 hours and required hospital stay. The patient has a urinary catheter placed for 6 to 9 days to facilitate bladder emptying. |
| External beam radiotherapy | Active comparator | Radiation: External beam radiotherapyExternal beam radiotherapy is carried out with intensity-modulated radiation technique. The treatment is designed to maximize the radiation dose to the prostate and seminal vesicles and minimize exposure to surrounding structures, including the bladder and rectum. Radiation to the prostate was delivered in fractionated doses divided over multiple treatments (180 to 200 centigray (cGy) daily fractions, 5 days per week) for a total dose to the prostate of 68 to 77 gray (Gy), prescribed at 90% to 100% of the isodose line. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age 75 years or younger
- Diagnosis of prostate cancer, as verified by cytologic or histologic examination the tumor is well differentiated to moderately well differentiated
- Untreated, clinically localized prostate cancer, with a tumor stage of T1, or T2
- Prostate specific antigen (PSA) level of ≤10 ng/ml
- Bone scan with no abnormalities
Key exclusion criteria (11 listed)
- PSA >10 ng/ml
- Bone scan consistent with metastatic disease
- Other evidence that cancer of the prostate is not clinically localized
- Life expectancy less than 10 years
- Serum creatinine greater than 3 mg/dl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical retropubic prostatectomyThe surgery arm underwent radical retropubic prostatectomy, performed by a technique described by Walsh. The prostatectomy is performed in retrograde way, preserving the neurovascular bundles if feasible. The degree to which the surgeon preserve the nerves is categorized as non-nerve-sparing, unilateral nerve-sparing, or bilateral nerve-sparing. Pelvic lymph node dissection is performed if feasible. The operative time is about 2 to 3 hours and required hospital stay. The patient has a urinary catheter placed for 6 to 9 days to facilitate bladder emptying. | Procedure or surgery | Radical retropubic prostatectomy |
| External beam radiotherapyExternal beam radiotherapy is carried out with intensity-modulated radiation technique. The treatment is designed to maximize the radiation dose to the prostate and seminal vesicles and minimize exposure to surrounding structures, including the bladder and rectum. Radiation to the prostate was delivered in fractionated doses divided over multiple treatments (180 to 200 centigray (cGy) daily fractions, 5 days per week) for a total dose to the prostate of 68 to 77 gray (Gy), prescribed at 90% to 100% of the isodose line. | Radiation | External beam radiotherapy |
Primary outcome
Biochemical disease-free survival
Time frame: up to 12 months
Number of participants who are free of biochemical relapse after a specified duration of time. Biochemical recurrence is measured by PSA levels. The definition of biochemical recurrence was based on a review of the literature and consideration of clinical practice in the year 1997. Biochemical recurrence among patients who underwent radical prostatectomy (RP) was defined as a measurable serum PSA concentration 0.2 ng/ml or greater. The American Society for Therapeutic Radiology and Oncology (ASTRO) criteria were used to define progression after radiation therapy. The ASTRO consensus definition specifies progression as 3 consecutive increases in serum PSA documented at intervals of 6 or more months.
6 secondary outcomes
•Perceived general health measured by the Medical Outcomes Study 36-Item Short Form (SF-36).
Time frame: 1, 3, 6, 12 and 24 months after treatment.
•Cancer specific Quality of Life measured by the Functional Assessment of Cancer Therapy - General and Prostate specific - (FACT-G and FACT-P, respectively).
Time frame: 1, 3, 6, 12 and 24 months after treatment.
•Urinary symptoms measured by the International Prostate Symptom Score (IPSS).
Time frame: 1, 3, 6, 12 and 24 months after treatment.
•Sexual symptoms measured by the International Index of Erectile Function (IIES).
Time frame: 1, 3, 6, 12 and 24 months after treatment.
Overall survival.
Time frame: 5, 7 and 10 years after treatment and every 5 years thereafter.
Prostate cancer-specific survival
Time frame: 3, 5, and 10 years after treatment and then every 5 years thereafter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Savino M. Di Stasi, MD, PhD study chair
Tor Vergata University of Rome
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radical retropubic prostatectomy and External beam radiotherapy in people with Prostate Cancer, run by University of Rome Tor Vergata.
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 7 inclusion and 11 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: paused, as of the sponsor's last update on 25 Mar 2020. 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 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?
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 disease-free survival (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2020.