Salvage radiotherapy for Prostatectomy

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Princess Margaret Cancer Center, Toronto, Canada
Prostatectomy+2 More
Salvage radiotherapy - Radiation
Eligibility
18+
Male
Eligible conditions
Select

Study Summary

Timing of Post-prostatectomy PSMA Imaging

See full description

Eligible Conditions

  • Prostatectomy
  • Prostate Cancer

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Salvage radiotherapy will improve 1 primary outcome in patients with Prostatectomy. Measurement will happen over the course of 7 years.

7 years
Surveillance with delayed PSMA PET scan

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Salvage radiotherapy
1 of 2
Surveillance
1 of 2
Active Control
Experimental Treatment

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Salvage Radiotherapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Surveillance
Radiation
Patients with early biochemical relapse of prostate cancer following radical prostatectomy who have a PSA greater than or equal to 0.1 to less than 0.3 ng/mL with negative PSMA PET/CT will go on surveillance. Routine PSA will be conducted and a repeat PSMA PET/CT imaging will be conducted when the PSA rises to greater than 0.5 to less than 1.0 ng/mL.
Salvage radiotherapyPatients with early biochemical relapse of prostate cancer following radical prostatectomy who have a PSA of greater than or equal to 0.1 to less than 0.3 ng/mL with negative PSMA PET/CT will receive salvage radiotherapy to the prostate bed. This radiotherapy may or may not include the pelvic lymph nodes.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 7 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 7 years for reporting.

Closest Location

Princess Margaret Cancer Center - Toronto, Canada

Eligibility Criteria

This trial is for male patients aged 18 and older. You must have received 1 prior treatment for Prostatectomy or one of the other 2 conditions listed above. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histologically-proven prostate cancer
pT1-T4 pN0/Nx cM0
PSA at BCR >0.1 - <0.3 ng/mL post-radical prostatectomy
PSMA PET/CT negative at BCR post radical prostatectomy
Planned SRT to prostate bed +/- pelvic lymph nodes
ECOG 0 or 1
Age ≥ 18 years
Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.

Patient Q&A Section

How many people get prostatectomy a year in the United States?

"Prostatectomy is the standard intervention for most men who have elevated PSA levels or biopsy proven and non-organ-confined [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer). For those who are older age, black race, or have low incomes, prostatectomy is generally only used after definitive radiation therapy has failed. In the remaining men, prostatectomy is commonly performed as first choice curative therapy. Prostatectomy is performed more frequently in the Northeast. Prostatectomy rates for the USA increased significantly from 1975 to 2003 owing to an ageing cohort. This change was associated with a steady decline in PSA screening." - Anonymous Online Contributor

Unverified Answer

What are common treatments for prostatectomy?

"The data collected showed the following: in the sample studied, most patients received a blood transfusion. When they were receiving an epidural, the average hemoglobin level was at a normal value. In all cases, the hemoglobin level fell to a normal level two post-operatively. The average post-operative blood loss was 1.15 L. The most common intervention by the doctors was a peripheral infusion and the least frequent intervention was a blood transfusion.\n\nThese are the most common reasons for prostatectomy.\nThe following are the most common treatments in a prostatectomy." - Anonymous Online Contributor

Unverified Answer

What are the signs of prostatectomy?

"The initial recovery lasts about 6 weeks, with symptoms such as pain, urgency and incontinence to urinate frequently and lasting for hours at a time. The risk of further complications is low provided that the patient follows a program of gradual adjustment of daily activities." - Anonymous Online Contributor

Unverified Answer

What causes prostatectomy?

"It is important to educate the patient on the reasons for having surgery and the benefits of it. Patients with high levels of baseline anxiety-related concerns, particularly concerning the negative effect of surgery on sexual potency, experience greater distress after prostatectomy. Patient expectations prior to surgery may need adjustment to better serve their needs." - Anonymous Online Contributor

Unverified Answer

Can prostatectomy be cured?

"Results from a recent clinical trial suggests that a cure is unlikely from prostatectomy alone but in the context of adjuvant therapies. The best survival rates and quality-of-life were seen with early, radical prostatectomy followed by adjuvant/combination therapies." - Anonymous Online Contributor

Unverified Answer

What is prostatectomy?

"A prostatectomy is an operation where part of the prostate is removed. It is often performed to remove cancer tumors of the prostate. It may also be used to treat a number of problems related to the prostate gland, including benign prostatic hyperplasia, an enlarged prostate and problems associated with the prostate's position and size. It can be performed as an open surgery, although typically it is done in a laparoscopic way, and the person heals at a hospital for a period of three to five days or less. It can also be done by means of the perineal or retropubic approach." - Anonymous Online Contributor

Unverified Answer

What is the latest research for prostatectomy?

"More than 80 new studies were published since 2005, which means that even if you were not at the forefront of the latest research, you are likely to be better informed about what is new about this surgery than many other men. For people in New England whose operation is being evaluated as part of their treatment for prostate cancer, this resource can aid in your treatment selection." - Anonymous Online Contributor

Unverified Answer

Does prostatectomy run in families?

"Data from a recent study showed that prostatectomy run in families and other familial cancers could be due to a combination of both genetic and environmental factors." - Anonymous Online Contributor

Unverified Answer

How does salvage radiotherapy work?

"Radiation therapy may be a reasonable salvage therapy for patients presenting ≥ 4 years after radical prostatectomy, as long as the PSA fails to fall below the nadir PSA level." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets prostatectomy?

"Recent findings from the Nationwide Inpatient Sample indicate that median age of men undergoing radical prostatectomy is 69 years. The use of newer biologic therapies and the increasing indications for prostatectomy are likely to boost this number. Moreover, our data indicate that men aged 90 years and older who undergo prostatectomy are 3.6 times as likely to have PSA>10 ng/ml as their younger counterparts. Therefore, these are patients who may benefit from early detection of prostate cancer and early treatment planning. These data suggest it may be prudent to counsel men more aggressively to manage PSA and prostate cancer." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating prostatectomy?

"Findings from a recent study found that the use of the robotic surgical system has led to a less traumatic approach with less blood loss in postoperative periods. Robotic systems are also advantageous in terms of decreased costs, which makes the use of this technology very useful. There were no significant differences in terms of continence or erectile function." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of salvage radiotherapy?

"The incidence of TRT-related adverse effects, including grade III skin reactions, varied among patients according to the clinical indication for salvage RT. The incidence of the complications was significantly higher in the first year after RT." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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