Feasibility Trial Of Image Guided External Beam Radiotherapy With Or Without High Dose Rate Brachytherapy Boost In Men With Intermediate-Risk Prostate Cancer

• Sponsor: Canadian Cancer Trials Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT01982786
• Collaborator: (none)
• Enrollment: 57
• Locations: 9
• Arms: 2
• Actual Duration (Months): 59.4
• Patients Per Site: 6.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This research is being done because investigators involved in this study would like to compare image guided external beam radiation therapy (IGRT) to IGRT plus HDR brachytherapy boost to see which treatment is better and what the side effects of treatment are.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Radiation: Image guided external beam radiotherapy with or without brachytherapy boost; Radiation: Brachytherapy	N/A

Detailed Description

Before a big study is done, a smaller study (called a "feasibility study") is required to make sure that patients and physicians are willing to participate in a study comparing the two kinds of treatments, and to verify how the radiation therapy is given in different centres across Canada.

The standard or usual treatment for this disease includes treatment with IGRT or IGRT plus HDR brachytherapy boost.

Study Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Randomized Phase II Feasibility Trial Of Image Guided External Beam Radiotherapy With Or Without High Dose Rate Brachytherapy Boost In Men With Intermediate-Risk Prostate Cancer
• Actual Study Start Date: Nov 5, 2013
• Actual Primary Completion Date: Jul 5, 2016
• Actual Study Completion Date: Oct 19, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1 IGRT* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions	Radiation: Image guided external beam radiotherapy with or without brachytherapy boost; image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost
Active Comparator: Arm 2 IGRT 37.5 Gy in 15 fractions + HDR brachytherapy boost 15 Gy	Radiation: Image guided external beam radiotherapy with or without brachytherapy boost; image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost; Radiation: Brachytherapy; Brachytherapy boost

Outcome Measures

Primary Outcome Measures

1. Feasibility of Ability to Accrue Patients [21 months]

   The ability to accrue 60 patients over an 18 month period to a study that randomizes men with intermediate-risk prostate cancer to curative intent treatment with image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost within a Canadian multicentre setting.

Secondary Outcome Measures

1. Number of Participants Reported Adverse Events [21 months]

   Acute genitourinary (GU) and gastrointestinal (GI) adverse events.

2. Treatment Compliance [21 months]

   Treatment compliance will be monitored on an ongoing basis by Central Office and the designated radiotherapy quality assurance reviewer and will be described for both arms.

3. Radiotherapy Quality Assurance -Timing [5 months]

   The time from the the time from IGRT Real Time Review Signed to IGRT Real Time Review Uploaded.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically confirmed prostate adenocarcinoma. The date of the last biopsy that verifies that the eligibility criterions have been met must be within 9 months prior to randomization. There must be no prior treatment.

• Intermediate-risk cancer patients based on the NCCN Guidelines (www.nccn.org):

• TNM classification:

• T2b-T2c and Gleason Score < 8/10 and PSA < 20 ng/ml; or

• T1c-T2a and Gleason Score 7/10 and PSA < 20 ng/ml; or

• T1c-T2a and Gleason Score ≤ 6/10 and 10 ≤ PSA < 20 ng/ml

For patients who have been on alpha reductase inhibitors within the last 6 months, use the following guidelines:

• T2b-T2c and Gleason Score < 8/10 and PSA ≤ 10 ng/ml; or

• T1c-T2a and Gleason Score 7/10 and PSA ≤ 10 ng/ml; or

• T1c-T2a and Gleason Score ≤ 6/10 and 5 ≤ PSA ≤ 10 ng/ml

• No alpha reductase inhibitors (i.e. avodart, proscar) use within 2 weeks of randomization. A washout period of 2 weeks is required prior to randomization.

• Prostate volume ≤ 75 cc.

• American Urological Association (AUA) Symptom Index score < 20.

• Judged to be medically fit for IGRT and HDR brachytherapy boost by a radiation oncologist.

• ECOG Performance Status of 0 or 1.

• ≥ 18 years of age.

• Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment in the trial to document their willingness to participate.

• Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial. Investigators must assure themselves the patients registered on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.

• Protocol treatment is to begin within 4 weeks of patient randomization. HDR brachytherapy boost treatment is to begin within 3 weeks before or after IGRT for those randomized to Arm 2.

• Participants must be willing to take precautions to prevent pregnancy while on treatment. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention). However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures, he is responsible for beginning contraceptive measures.

Exclusion Criteria:

• History of transurethral resection of the prostate (TURP).

• Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.

• Prior or current bleeding diathesis.

• Prior pelvic or prostate radiotherapy.

• Previous history of (or planned) androgen deprivation therapy.

• Evidence of metastatic disease.

• Any serious active disease or co-morbid medical condition, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. H. Bliss Murphy Cancer Centre	St. John's	Newfoundland and Labrador	Canada	A1B 3V6
2	Royal Victoria Regional Health Centre	Barrie	Ontario	Canada	L4M 6M2
3	Lakeridge Health Oshawa	Oshawa	Ontario	Canada	L1G 2B9
4	Odette Cancer Centre	Toronto	Ontario	Canada	M4N 3M5
5	Univ. Health Network-Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9
6	Windsor Regional Cancer Centre	Windsor	Ontario	Canada	N8W 2X3
7	CHUM - Hopital Notre-Dame	Montreal	Quebec	Canada	H2L 4M1
8	McGill University - Dept. Oncology	Montreal	Quebec	Canada	H2W 1S6
9	CHUQ-Pavillon Hotel-Dieu de Quebec	Quebec City	Quebec	Canada	G1R 2J6

Sponsors and Collaborators

• Canadian Cancer Trials Group

Investigators

• Study Chair: Eric Vigneault, CHUQ - Hotel Dieu de Quebec, Quebec QC
• Study Chair: Douglas Loblaw, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto On

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Canadian Cancer Trials Group
• ClinicalTrials.gov Identifier: NCT01982786
• Other Study ID Numbers: PR15
• First Posted: Nov 13, 2013
• Last Update Posted: Oct 22, 2020
• Last Verified: Mar 1, 2017

• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Arm/Group Title	Arm 1	Arm 2
Arm/Group Description	IGRT* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost	IGRT 37.5 Gy in 15 fractions + HDR brachytherapy boost 15 Gy Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost Brachytherapy: Brachytherapy boost
Period Title: Overall Study
STARTED	29	28
COMPLETED	29	28
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Arm 1	Arm 2	Total
Arm/Group Description	IGRT* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost	IGRT 37.5 Gy in 15 fractions + HDR brachytherapy boost 15 Gy Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost Brachytherapy: Brachytherapy boost	Total of all reporting groups
Overall Participants	29	28	57
Age, Customized (Count of Participants)
<= 65 years	13 44.8%	11 39.3%	24 42.1%
> 65 years	16 55.2%	17 60.7%	33 57.9%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	29 100%	28 100%	57 100%
Prostate Carcinoma Disease clinical T Stage (Count of Participants)
T1c	18 62.1%	13 46.4%	31 54.4%
T2a	7 24.1%	11 39.3%	18 31.6%
T2b	3 10.3%	3 10.7%	6 10.5%
T2c	1 3.4%	1 3.6%	2 3.5%
PSA (Count of Participants)
< 10	20 69%	24 85.7%	44 77.2%
10-20	9 31%	4 14.3%	13 22.8%
The AUA Symptom Index Score (Count of Participants)
AUA score from 0 to 9	18 62.1%	21 75%	39 68.4%
AUA score from 10 to 19	11 37.9%	7 25%	18 31.6%
combined Gleason Score (Count of Participants)
Gleason Score of 7	29 100%	28 100%	57 100%
Others	0 0%	0 0%	0 0%
The ECOG Scale of Performance Status (Count of Participants)
0	29 100%	27 96.4%	56 98.2%
Missing	0 0%	1 3.6%	1 1.8%

Outcome Measures

1. Primary Outcome

Title	Feasibility of Ability to Accrue Patients
Description	The ability to accrue 60 patients over an 18 month period to a study that randomizes men with intermediate-risk prostate cancer to curative intent treatment with image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost within a Canadian multicentre setting.
Time Frame	21 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1	Arm 2
Arm/Group Description	IGRT* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost	IGRT 37.5 Gy in 15 fractions + HDR brachytherapy boost 15 Gy Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost Brachytherapy: Brachytherapy boost
Measure Participants	29	28
Count of Participants [Participants]	29 100%	28 100%

2. Secondary Outcome

Title	Number of Participants Reported Adverse Events
Description	Acute genitourinary (GU) and gastrointestinal (GI) adverse events.
Time Frame	21 months

Outcome Measure Data

Analysis Population Description

As treated population

Arm/Group Title	Arm 1	Arm 2
Arm/Group Description	IGRT* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost	IGRT 37.5 Gy in 15 fractions + HDR brachytherapy boost 15 Gy Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost Brachytherapy: Brachytherapy boost
Measure Participants	29	26
GASTROINTESTINAL DISORDERS	1 3.4%	0 0%
RENAL AND URINARY DISORDERS	0 0%	2 7.1%

3. Secondary Outcome

Title	Treatment Compliance
Description	Treatment compliance will be monitored on an ongoing basis by Central Office and the designated radiotherapy quality assurance reviewer and will be described for both arms.
Time Frame	21 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1	Arm 2
Arm/Group Description	IGRT* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost	IGRT 37.5 Gy in 15 fractions + HDR brachytherapy boost 15 Gy Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost Brachytherapy: Brachytherapy boost
Measure Participants	29	26
Minor Deviation	14 48.3%	18 64.3%
Major Deviation	3 10.3%	2 7.1%

4. Secondary Outcome

Title	Radiotherapy Quality Assurance -Timing
Description	The time from the the time from IGRT Real Time Review Signed to IGRT Real Time Review Uploaded.
Time Frame	5 months

Outcome Measure Data

Analysis Population Description

As treated population.

Arm/Group Title	Arm 1	Arm 2
Arm/Group Description	IGRT* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost	IGRT 37.5 Gy in 15 fractions + HDR brachytherapy boost 15 Gy Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost Brachytherapy: Brachytherapy boost
Measure Participants	29	26
Median (Full Range) [Day]	4	3

Adverse Events

Arm/Group Title	Arm 1		Arm 2
Arm/Group Description	IGRT* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost		IGRT 37.5 Gy in 15 fractions + HDR brachytherapy boost 15 Gy Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost Brachytherapy: Brachytherapy boost
All Cause Mortality
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/29 (3.4%)		2/26 (7.7%)
Serious Adverse Events
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/29 (3.4%)		2/26 (7.7%)
Gastrointestinal disorders
Diarrhea	1/29 (3.4%)		0/26 (0%)
Renal and urinary disorders
Hematuria	0/29 (0%)		2/26 (7.7%)
Other (Not Including Serious) Adverse Events
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/26 (0%)

Limitations/Caveats

Limited follow up time, delayed side effect might not be captured.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.