Prostate CancerNCT00084552
Intensity-Modulated Radiation Therapy With or Without Decreased Radiation Dose to Erectile Tissue in Treating Patients With Stage II Prostate Cancer
A study testing radiation therapy in people with Prostate Cancer and Sexual Dysfunction, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) may reduce damage to healthy tissue near the tumor. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Sexual Dysfunction, Sexuality and Reproductive Issues
- What is being tested?
- radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2003to 5 May 2016
- Phase
- Interventional
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Clinical stage T1b-T2c by palpation
- Pretreatment prostate-specific antigen ≤ 20 ng/mL
- Gleason score ≤ 7
- Suitable erectile function, defined as a response ≥ score 2 in question #1 of the International Index of Erectile Function Questionnaire
- No clinical, radiographic, or pathologic evidence of nodal or distant metastatic disease
PATIENT CHARACTERISTICS:
Age
- Not specified
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Fertile patients must use effective contraception
- No other active malignancy within the past 5 years except nonmetastatic skin cancer or early-stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma)
- No other medical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Prior androgen-ablation therapy allowed provided total calculated duration ≤ 4 months
Radiotherapy
- No prior pelvic radiotherapy
Surgery
- No prior or planned radical prostate surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497
About this study
Official title: Outcomes Following Intensity Modulated Radiation Therapy With And Without Erectile Tissue Dose Sparing For Favorable To Intermediate Risk Prostate Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) may reduce damage to healthy tissue near the tumor. It is not yet known whether reducing the dose of radiation to erectile tissue will help prevent erectile dysfunction.
PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy alone to see how well it works compared to intensity-modulated radiation therapy with reduced doses to erectile tissue in treating patients with stage II prostate cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare erectile dysfunction in patients with stage T1b-T2c adenocarcinoma of the prostate after treatment with intensity-modulated radiotherapy with vs without dose sparing for erectile tissue.
Secondary
- Compare biochemical freedom from failure rates, as a measure of prostate cancer control, in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Determine the association of molecular markers and biochemical freedom from failure rate and other endpoints in patients treated with these regimens.
OUTLINE: This is a randomized, single-blind study. Patients are stratified according to age (≤ 65 vs > 65), prescription radiotherapy dose (74 Gy vs 76 Gy), and frequency of erection during sexual activity within the past 4 weeks (a few times vs sometimes vs most times to always). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
- Arm II: Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks.
Treatment in both arms continues in the absence of unacceptable toxicity or disease metastasis.
Quality of life is assessed at baseline, at 6 and 12 months, and then annually for 4 years
Patients are followed at 3 months and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study within 2.5 years.
- Being tested
- radiation therapy
- Keywords
- sexual dysfunction, sexuality and reproductive issues, adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer
- Medical subject headings
- Prostatic Neoplasms, Sexual Dysfunction, Physiological, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiation therapyRadiation
Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Active comparator | Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks. Receives: Radiation: radiation therapy |
| Arm II | Experimental | Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks. Receives: Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erectile Dysfunction Rates
Postage Stamp Test
-A row of stamps is placed around the base of the penis and the ends are moistened and joined. If the circle is broken in the morning then the subject was recorded as having had a nocturnal erection
International Index of Erectile Function (IIEF) Questionnaire
- 15-item questionnaire that measures erectile function
- Includes companion questionnaire which measures how the partner feels her sexual relationship with the patient has changed since his cancer diagnosis and therapy
Measured: 5 year duration after completion of radiotherapy
Secondary outcomes (3)
Percentage of Patients With Freedom From Biochemical Failure
Patients without documented failure will undergo needle biopsy of the prostate. A minimum of 12 core biopsies will be taken and additional biopsies will be taken from any suspicious areas (ultrasound or palpation) and/or the original site of biopsy confirmation of prostate cancer at diagnosis. The 12 biopsy sites include sextant, bilateral lateral base, bilateral lateral mid-gland and bilateral transition zone. These data will enable us to evaluate the extent of disease eradication, as well as the prognostic significance of positive biopsies in otherwise palpably normal prostate glands after treatment.
Measured: 2 years after treatment
Acute GI Toxicity
Measured: 5 years after treatment
Acute GU Toxicity
Measured: 5 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2004 (estimated)
- Study start11 Dec 2003
- Primary completion24 Aug 2013
- Study completion5 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Horwitz, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00084552
- Sponsor's protocol ID
- 03-028
- Other IDs
- CDR0000365458
- Status last verified
- Feb 2021
- First submitted
- 10 Jun 2004
- Last updated
- 25 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Following Intensity Modulated Radiation Therapy With And Without Erectile Tissue Dose Sparing For Favorable To Intermediate Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT00084552
- Acronym / sponsor ID
- 03-028
- Keywords
- sexual dysfunction, sexuality and reproductive issues, adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- 11 Dec 2003 (actual)
- Primary completion
- 24 Aug 2013 (actual)
- Study completion
- 5 May 2016 (actual)
- First posted
- 11 Jun 2004 (estimated)
- Results
- Posted 25 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) may reduce damage to healthy tissue near the tumor. It is not yet known whether reducing the dose of radiation to erectile tissue will help prevent erectile dysfunction.
PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy alone to see how well it works compared to intensity-modulated radiation therapy with reduced doses to erectile tissue in treating patients with stage II prostate cancer.
Detailed description
OBJECTIVES:
Primary
- Compare erectile dysfunction in patients with stage T1b-T2c adenocarcinoma of the prostate after treatment with intensity-modulated radiotherapy with vs without dose sparing for erectile tissue.
Secondary
- Compare biochemical freedom from failure rates, as a measure of prostate cancer control, in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Determine the association of molecular markers and biochemical freedom from failure rate and other endpoints in patients treated with these regimens.
OUTLINE: This is a randomized, single-blind study. Patients are stratified according to age (≤ 65 vs > 65), prescription radiotherapy dose (74 Gy vs 76 Gy), and frequency of erection during sexual activity within the past 4 weeks (a few times vs sometimes vs most times to always). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
- Arm II: Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks.
Treatment in both arms continues in the absence of unacceptable toxicity or disease metastasis.
Quality of life is assessed at baseline, at 6 and 12 months, and then annually for 4 years
Patients are followed at 3 months and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study within 2.5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Active comparator | Radiation: radiation therapyPatients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks. |
| Arm II | Experimental | Radiation: radiation therapyPatients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| radiation therapyPatients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks. | Radiation | Arm I, Arm II |
Primary outcome
Erectile Dysfunction Rates
Time frame: 5 year duration after completion of radiotherapy
Postage Stamp Test -A row of stamps is placed around the base of the penis and the ends are moistened and joined. If the circle is broken in the morning then the subject was recorded as having had a nocturnal erection International Index of Erectile Function (IIEF) Questionnaire * 15-item questionnaire that measures erectile function * Includes companion questionnaire which measures how the partner feels her sexual relationship with the patient has changed since his cancer diagnosis and therapy
3 secondary outcomes
Percentage of Patients With Freedom From Biochemical Failure
Time frame: 2 years after treatment
Acute GI Toxicity
Time frame: 5 years after treatment
Acute GU Toxicity
Time frame: 5 years after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Eric Horwitz, MD principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiation therapy in people with Prostate Cancer and Sexual Dysfunction, run by Fox Chase Cancer Center at 1 site 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?
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: finished, as of the sponsor's last update on 25 Feb 2021. 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2021). 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?
Erectile Dysfunction Rates (time frame: 5 year duration after completion of radiotherapy). 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 Feb 2021.