Prostate CancerPhase 2NCT00003307
Radiation Therapy Plus Amifostine in Treating Patients With Primary Prostate Cancer
A Phase 2 study testing amifostine trihydrate and radiation therapy in people with Prostate Cancer and Radiation Toxicity, run by University of Arizona at 1 site in United States.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Amifostine may protect normal cells from the side effects of radiation therapy. PURPOSE: Phase II trial to study the effectiveness of radiation therapy plus amifostine in treating patients with primary prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Radiation Toxicity
- What is being tested?
- amifostine trihydrate and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1998to Jun 2001
- 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
DISEASE CHARACTERISTICS: Histologically confirmed prostate adenocarcinoma Stage T1a-T3b N0 M0 disease PSA at least 10 ng/mL prior to treatment Must have a risk of seminal vesicle involvement between 10-25% No palpable or radiographic evidence of seminal vesicle involvement
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Greater than 24 months Hematopoietic: Not specified Hepatic: SGOT and SGOT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No severe cerebrovascular disease or sustained hypotension not secondary to antihypotensive medication Other: No history of inflammatory bowel disease No history of malignancy other than nonmelanoma skin cancer No underlying medical or psychiatric illness that may impair ability to participate in study
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the prostate area Surgery: No prior radical prostatectomy Other: No hypertensive medications if blood pressure less than 120/70
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Open Label Trial of Amifostine Plus Fractionated Radiotherapy for Primary Prostate Adenocarcinoma (T1a-T3b, NoMo, PSA>10 ng/ml) to Estimate Acute Grade 2 Genitourinary and Gastrointestinal Toxicity
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Amifostine may protect normal cells from the side effects of radiation therapy.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy plus amifostine in treating patients with primary prostate cancer.
Read the detailed description
OBJECTIVES: I. Determine the incidence, grade, and time course of acute grade 2 or higher gastrointestinal and genitourinary toxicities in patients with primary prostate adenocarcinoma receiving amifostine plus fractionated radiotherapy. II. Determine the incidence and nature of toxicity associated with amifostine in these patients. III. Assess tumor response to this treatment in these patients. IV. Assess impotency rates following radiotherapy in these patients.
OUTLINE: This is an open label study. Patients receive fractionated radiotherapy five days per week for 7 weeks plus amifostine IV push over 5 minutes, 15 minutes before each radiation treatment. Patients are followed at 1 month after radiotherapy, and then every 3 months for at least 5 years.
PROJECTED ACCRUAL: There will be 25 patients accrued into this study over 2 years.
- Conditions
- Prostate Cancer, Radiation Toxicity
- Being tested
- amifostine trihydrate, radiation therapy
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, radiation toxicity
- Medical subject headings
- Prostatic Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amifostine trihydrateDrug
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2004 (estimated)
- Study startMar 1998
- Primary completionJun 2001
- Study completionJun 2001
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.
- More trials run by University of ArizonaThe 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 2
- Primary purpose
- Treatment
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- James R. Oleson, MD, PhD, Study chair, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003307
- Sponsor's protocol ID
- CDR0000066254
- Other IDs
- P30CA023074, UARIZ-HSC-9817, ALZA-98-005-ii, NCI-V98-1412
- Status last verified
- May 2006
- First submitted
- 1 Nov 1999
- Last updated
- 16 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open Label Trial of Amifostine Plus Fractionated Radiotherapy for Primary Prostate Adenocarcinoma (T1a-T3b, NoMo, PSA>10 ng/ml) to Estimate Acute Grade 2 Genitourinary and Gastrointestinal Toxicity
- ClinicalTrials.gov ID
- NCT00003307
- Acronym / sponsor ID
- CDR0000066254
- Conditions
- Prostate Cancer, Radiation Toxicity
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, radiation toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 1998
- Primary completion
- Jun 2001 (actual)
- Study completion
- Jun 2001 (actual)
- First posted
- 14 Apr 2004 (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.
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Amifostine may protect normal cells from the side effects of radiation therapy.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy plus amifostine in treating patients with primary prostate cancer.
Detailed description
OBJECTIVES: I. Determine the incidence, grade, and time course of acute grade 2 or higher gastrointestinal and genitourinary toxicities in patients with primary prostate adenocarcinoma receiving amifostine plus fractionated radiotherapy. II. Determine the incidence and nature of toxicity associated with amifostine in these patients. III. Assess tumor response to this treatment in these patients. IV. Assess impotency rates following radiotherapy in these patients.
OUTLINE: This is an open label study. Patients receive fractionated radiotherapy five days per week for 7 weeks plus amifostine IV push over 5 minutes, 15 minutes before each radiation treatment. Patients are followed at 1 month after radiotherapy, and then every 3 months for at least 5 years.
PROJECTED ACCRUAL: There will be 25 patients accrued into this study over 2 years.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| amifostine trihydrate | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2010.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
James R. Oleson, MD, PhD study chair
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing amifostine trihydrate and radiation therapy in people with Prostate Cancer and Radiation Toxicity, run by University of Arizona 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 16 Mar 2010. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 16 Mar 2010.