Trial · Interventional

TerminatedPhase 3Registry data

Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial

NCTNCT00243646Other id05-8-4

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: poor accrual

Overview

Status: Terminated
Phase: Phase 3
Enrollment: 6 participants (actual)
Sponsor: Schiffler Cancer Center · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Aug 2004
Primary completion: Jul 2009
Completion: Jul 2009
First posted: 24 Oct 2005 (estimated)
Last update posted: 14 Apr 2016 (estimated)
Conditions: Prostate Cancer

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2004200520062007200820092010

Ph 3
Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial
NCT00243646
Aug 2004 to Jul 2009
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Determine the role of androgen deprivation therapy in high risk patients receiving 45 Gy of pelvic radiotherapy plus a Pd-103 boost and the impact of the duration of ADT in hormonally-manipulated patients.

Interventions

External beam radiationRadiation
LupronDrug
CasodexDrug

Arms2

Active comparator
no hormones
All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant with no hormones
Active comparator
9 months of hormone therapy
All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant with a 9 month course of hormone therapy

Primary outcomes3

Outcomes the sponsor listed as primary.

PSA 3 and 6 months following implantation then every 6 months.
Time frame · 3 and 6 months following implantation then every 6 months
Registry description
PSA 3 and 6 months following implantation then every 6 months.
Serum testosterone levels at 3 and 6 months in hormonally manipulated patients.
Time frame · 3 and 6 months
Registry description
Serum testosterone levels at 3 and 6 months in hormonally manipulated patients
Androgen deprivation therapy will not be reinitiated unless the post-treatment PSA exceeds 10 ng/mL or distant metastases are detected.
Time frame · as needed
Registry description
Androgen deprivation therapy will not be reinitiated unless the post-treatment PSA exceeds 10 ng/mL or distant metastases are detected.

Secondary outcomes(3)

EPIC on 6 and 12 months and then annually.
Time frame · 6 and 12 months and then annually.
Registry description
EPIC on 6 and 12 months and then annually.
Hormonally manipulated patients will obtain a DEXA scan.
Time frame · as needed
Registry description
Hormonally manipulated patients will obtain a DEXA scan.
For documented osteoporosis, Zometa (4 mg IV over 15 minutes) every 3 months is recommended.
Time frame · every 3 months is recommended.
Registry description
For documented osteoporosis, Zometa (4 mg IV over 15 minutes) every 3 months is recommended.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 1997

6 results

Phase III trial of androgen suppression using goserelin in unfavorable-prognosis carcinoma of the prostate treated with definitive radiotherapy: report of Radiation Therapy Oncology Group Protocol 85-31.

Pilepich et al. 1997Journal of clinical oncology : official journal of the American Society of Clinical Oncologycited by 399

PMID 9060541DOI 10.1200/jco.1997.15.3.1013PUB-09060541

Full text at the publisher6 results

Publisher page See results (6)

More studies

2 studies on this page

Indexing hint: Randomized controlled trial · 2004

Report of a multicenter Canadian phase III randomized trial of 3 months vs. 8 months neoadjuvant androgen deprivation before standard-dose radiotherapy for clinically localized prostate cancer.

Crook et al. 2004International journal of radiation oncology, biology, physicscited by 83

PMID 15337535DOI 10.1016/j.ijrobp.2004.02.022PUB-15337535

Full text at the publisher

Publisher page

Indexing hint: Randomized controlled trial · 2002

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.

Bolla et al. 2002Lancet (London, England)cited by 1,178

PMID 12126818DOI 10.1016/s0140-6736(02)09408-4PUB-12126818

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: Male
Age: Not stated
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * High risk patients - Two to three of the following: PSA 10-30 ng/mL, Gleason score greater than or equal to 6, clinical stage greater than or equal to T2c (2002 ACJJ). * CT of the abdomen and pelvis and bone scan without evidence of metastases. * An enzymatic prostatic acid phosphatase must be obtained prior to randomization. * A serum testosterone must be obtained prior to initiation of androgen deprivation therapy. * No prior pelvic external beam radiation therapy for prostate cancer or other malignancies. * No prior androgen deprivation therapy. * Minimum 5 year life expectancy. * No other invasive cancer diagnosis other than non-melanoma skin cancer within the last 5 years. Exclusion Criteria: * Exclusion criteria will be limited to patients who do not meet the above eligibility criteria.

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